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U.S. Department of Health and Human Services

Class 2 Device Recall Prestige Coil System

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  Class 2 Device Recall Prestige Coil System see related information
Date Initiated by Firm January 03, 2024
Date Posted February 08, 2024
Recall Status1 Open3, Classified
Recall Number Z-1042-2024
Recall Event ID 93751
510(K)Number K220699  
Product Classification Device, Vascular, for Promoting Embolization - Product Code KRD
Product The Prestige Coil System is a product family of embolic coils with associated delivery system components. These devices are angiographically delivered through the vasculature to embolize peripheral vascular abnormalities. The devices are to be placed to create blood stasis, reducing flow into the anomaly, and thrombosing the target site. The Prestige Coil System is comprised of the implant coil and a pusher assembly. There are a total of 81 Prestige coil models. Vascular Embolization Device Prestige Coil Model Numbers and Product description: PRES0413CPKPL Prestige Coil 4mm x 13cm Prestige Plus Complex Pack PRES1137COM18 Prestige Coil 11mm x 37cm Complex-18 PRES0202CXPPL Prestige Coil 2mm x 2cm Prestige Plus Complex Xtra Pac PRES0203CXPPL Prestige Coil 2mm x 3cm Prestige Plus Complex Xtra Pac PRES0410CPKPL Prestige Coil 4mm x 10cm Prestige Plus Complex Pack PRES0413CPKPL Prestige Coil 4mm x 13cm Prestige Plus Complex Pack PRES0315HXPPL Prestige Coil 3mm x 15cm Prestige Plus Helical Xtra Pac PRES0420HPKPL Prestige Coil 4mm x 20cm Prestige Plus Helical Pack PRES0520HPKPL Prestige Coil 5mm x 20cm Prestige Plus Helical Pack PRES0620HPKPL Prestige Coil 6mm x 20cm Prestige Plus Helical Pack PRES0720CPKPL Prestige Coil 7mm x 20cm Prestige Plus Complex Pack PRES0930CPKPL Prestige Coil 9mm x 30cm Prestige Plus Complex Pack PRES0101HXPPL Prestige Coil 1mm x 1cm Prestige Plus Helical Xtra Pac PRES0153HXPPL Prestige Coil 1.5mm x 3cm Prestige Plus Helical Xtra Pac PRES0720HPKPL Prestige Coil 7mm x 20cm Prestige Plus Helical Pack PRES0830HPKPL Prestige Coil 8mm x 30cm Prestige Plus Helical Pack PRES0930HPKPL Prestige Coil 9mm x 30cm Prestige Plus Helical Pack PRES1040HPKPL Prestige Coil 10mm x 40cm Prestige Plus Helical Pack PRES1240COM18 Prestige Coil 12mm x 40cm Complex-18 PRES0204CXPPL Prestige Coil 2mm x 4cm Prestige Plus Complex Xtra Pac PRES0206CXPPL Prestige Coil 2mm x 6cm Prestige Plus Complex Xtra Pac PRES0310CXPPL Prestige Coil 3mm x 10cm Prestige Plus Complex Xtra Pac PRES0620CPKPL Prestige Coil 6mm x 20cm Prestige Plus Complex Pack PRES0830CPKPL Prestige Coil 8mm x 30cm Prestige Plus Complex Pack PRES0210CXP10 Prestige Coil 2mm x 10cm Complex-10 Xtra Pack PRES0258CXP10 Prestige Coil 2.5mm x 8cm Complex-10 Xtra Pack PRES0417CPK10 Prestige Coil 4mm x 17cm Complex-10 Xtra Pack PRES0520CPK10 Prestige Coil 5mm x 20cm Complex-10 Xtra Pack PRES0615CPK10 Prestige Coil 6mm x 15cm Complex-10 Xtra Pack PRES0103CXPPL Prestige Coil 1mm x 3cm Prestige Plus Complex Xtra Pac PRES0152CXPPL Prestige Coil 1.5mm x 2cm Prestige Plus Complex Xtra Pac PRES0413CPKPL Prestige Coil 4mm x 13cm Prestige Plus Complex Pack PRES2525HXPPL Prestige Coil 2.5mm x 2.5cm Prestige Plus Helical Xtra Pac PRES1040CPKPL Prestige Coil 10mm x 40cm Prestige Plus Complex Pack PRES0307CXPPL Prestige Coil 3mm x 7cm Prestige Plus Complex Xtra Pac PRES0517CPKPL Prestige Coil 5mm x 17cm Prestige Plus Complex Pack PRES0620CPKPL Prestige Coil 6mm x 20cm Prestige Plus Complex Pack PRES0152CXPPL Prestige Coil 1.5mm x 2cm Prestige Plus Complex Xtra Pac PRES0413CRG10 Prestige Coil 4mm x 13cm Complex 10 Regular PRES0153CXPPL Prestige Coil 1.5mm x 3cm Prestige Plus Complex Xtra Pac PRES0255CXPPL Prestige Coil 2.5mm x 5cm Prestige Plus Complex Xtra Pac PRES0358CXPPL Prestige Coil 3.5mm x 8cm Prestige Plus Complex Xtra Pac PRES0410CPKPL Prestige Coil 4mm x 10cm Prestige Plus Complex Pack PRES1040CPKPL Prestige Coil 10mm x 40cm Prestige Plus Complex Pack PRES0420HPKPL Prestige Coil 4mm x 20cm Prestige Plus Helical Pack PRES0520HPKPL Prestige Coil 5mm x 20cm Prestige Plus Helical Pack PRES0204HXP10 Prestige Coil 2mm x 4cm Helical-10 Xtra Pack PRES0206HXP10 Prestige Coil 2mm x 6cm Helical-10 Xtra Pack PRES1447COM18 Prestige Coil 14mm x 47cm Complex-18 PRES0204HXP10 Prestige Coil 2mm x 4cm Helical-10 Xtra Pack PRES0306HPK10 Prestige Coil 3mm x 6cm Helical-10 Pack PRES0310HPK10 Prestige Coil 3mm x 10cm Helical-10 Pack PRES0410HPK10 Prestige Coil 4mm x 10cm Helical-10 Pack PRES0930H
Code Information Refer to Attachment 1 for list of affected products including the products' Lot Number, Product model number, UDI and expiration date. Prestige Coils ( Lot Number/Model Number/Product Description/UDI-DI Code: F201000210 PRES0413CPKPL Prestige Coil 4mm x 13cm Prestige Plus Complex Pack 00818053027451 F201000231 PRES1137COM18 Prestige Coil 11mm x 37cm Complex-18 00818053023217 F201000319 PRES0202CXPPL Prestige Coil 2mm x 2cm Prestige Plus Complex Xtra Pac 00818053027307 F201000320 PRES0203CXPPL Prestige Coil 2mm x 3cm Prestige Plus Complex Xtra Pac 00818053027314 F201000321 PRES0410CPKPL Prestige Coil 4mm x 10cm Prestige Plus Complex Pack 00818053027444 F201000322 PRES0413CPKPL Prestige Coil 4mm x 13cm Prestige Plus Complex Pack 00818053027451 F201000323 PRES0315HXPPL Prestige Coil 3mm x 15cm Prestige Plus Helical Xtra Pac 00818053027178 F201000324 PRES0420HPKPL Prestige Coil 4mm x 20cm Prestige Plus Helical Pack 00818053027185 F201000325 PRES0520HPKPL Prestige Coil 5mm x 20cm Prestige Plus Helical Pack 00818053027192 F201000326 PRES0620HPKPL Prestige Coil 6mm x 20cm Prestige Plus Helical Pack 00818053027208 F201000329 PRES0720CPKPL Prestige Coil 7mm x 20cm Prestige Plus Complex Pack 00818053027550 F201000330 PRES0930CPKPL Prestige Coil 9mm x 30cm Prestige Plus Complex Pack 00818053027581 F201000331 PRES0101HXPPL Prestige Coil 1mm x 1cm Prestige Plus Helical Xtra Pac 00818053027109 F201000332 PRES0153HXPPL Prestige Coil 1.5mm x 3cm Prestige Plus Helical Xtra Pac 00818053027147 F201000333 PRES0720HPKPL Prestige Coil 7mm x 20cm Prestige Plus Helical Pack 00818053027215 F201000334 PRES0830HPKPL Prestige Coil 8mm x 30cm Prestige Plus Helical Pack 00818053027222 F201000335 PRES0930HPKPL Prestige Coil 9mm x 30cm Prestige Plus Helical Pack 00818053027239 F201000336 PRES1040HPKPL Prestige Coil 10mm x 40cm Prestige Plus Helical Pack 00818053027246 F201000450 PRES1240COM18 Prestige Coil 12mm x 40cm Complex-18 00818053023224 F201000451 PRES0204CXPPL Prestige Coil 2mm x 4cm Prestige Plus Complex Xtra Pac 00818053027321 F201000452 PRES0206CXPPL Prestige Coil 2mm x 6cm Prestige Plus Complex Xtra Pac 00818053027338 F201000453 PRES0310CXPPL Prestige Coil 3mm x 10cm Prestige Plus Complex Xtra Pac 00818053027383 F201000454 PRES0620CPKPL Prestige Coil 6mm x 20cm Prestige Plus Complex Pack 00818053027536 F201000455 PRES0830CPKPL Prestige Coil 8mm x 30cm Prestige Plus Complex Pack 00818053027574 F201000516 PRES0210CXP10 Prestige Coil 2mm x 10cm Complex-10 Xtra Pack 00818053027604 F201000517 PRES0258CXP10 Prestige Coil 2.5mm x 8cm Complex-10 Xtra Pack 00818053027611 F201000518 PRES0417CPK10 Prestige Coil 4mm x 17cm Complex-10 Xtra Pack 00818053027642 F201000520 PRES0520CPK10 Prestige Coil 5mm x 20cm Complex-10 Xtra Pack 00818053027659 F201000521 PRES0615CPK10 Prestige Coil 6mm x 15cm Complex-10 Xtra Pack 00818053027666 F201000522 PRES0103CXPPL Prestige Coil 1mm x 3cm Prestige Plus Complex Xtra Pac 00818053027277 F201000523 PRES0152CXPPL Prestige Coil 1.5mm x 2cm Prestige Plus Complex Xtra Pac 00818053027284 F201000524 PRES0413CPKPL Prestige Coil 4mm x 13cm Prestige Plus Complex Pack 00818053027451 F201000526 PRES2525HXPPL Prestige Coil 2.5mm x 2.5cm Prestige Plus Helical Xtra Pac 00818053027154 F201000527 PRES1040CPKPL Prestige Coil 10mm x 40cm Prestige Plus Complex Pack 00818053027598 F201000564 PRES0307CXPPL Prestige Coil 3mm x 7cm Prestige Plus Complex Xtra Pac 00818053027376 F201000571 PRES0517CPKPL Prestige Coil 5mm x 17cm Prestige Plus Complex Pack 00818053027505 F201000572 PRES0620CPKPL Prestige Coil 6mm x 20cm Prestige Plus Complex Pack 00818053027536 F201000575 PRES0152CXPPL Prestige Coil 1.5mm x 2cm Prestige Plus Complex Xtra Pac 00818053027284 F201000788 PRES0413CRG10 Prestige Coil 4mm x 13cm Complex 10 Regular 00818053027703 F201000789 PRES0153CXPPL Prestige Coil 1.5mm x 3cm Prestige Plus Complex Xtra Pac 00818053027291 F201000790 PRES0255CXPPL Prestige Coil 2.5mm x 5cm Prestige Plus Complex Xtra Pac 00818053027352 F201000791 PRES0358CXPPL Prestige Coil 3.5mm x 8cm Prestige Plus Complex Xtra Pac 00818053027413 F201000792 PRES0410CPKPL Prestige Coil 4mm x 10cm Prestige Plus Complex Pack 00818053027444 F201000793 PRES1040CPKPL Prestige Coil 10mm x 40cm Prestige Plus Complex Pack 00818053027598 F201000794 PRES0420HPKPL Prestige Coil 4mm x 20cm Prestige Plus Helical Pack 00818053027185 F201000795 PRES0520HPKPL Prestige Coil 5mm x 20cm Prestige Plus Helical Pack 00818053027192 F201001014 PRES0204HXP10 Prestige Coil 2mm x 4cm Helical-10 Xtra Pack 00818053023989 F201001025 PRES0206HXP10 Prestige Coil 2mm x 6cm Helical-10 Xtra Pack 00818053023996 F201001126 PRES1447COM18 Prestige Coil 14mm x 47cm Complex-18 00818053023248 F201001139 PRES0204HXP10 Prestige Coil 2mm x 4cm Helical-10 Xtra Pack 00818053023989 F201100055 PRES0306HPK10 Prestige Coil 3mm x 6cm Helical-10 Pack 00818053024153 F201100056 PRES0310HPK10 Prestige Coil 3mm x 10cm Helical-10 Pack 00818053024177 F201100057 PRES0410HPK10 Prestige Coil 4mm x 10cm Helical-10 Pack 00818053024207 F201100058 PRES0930HRG10 Prestige Coil 9mm x 30cm Helical-10 Regular 00818053024337 F201100059 PRES0102CXPPL Prestige Coil 1mm x 2cm Prestige Plus Complex Xtra Pac 00818053027260 F201100060 PRES0103CXPPL Prestige Coil 1mm x 3cm Prestige Plus Complex Xtra Pac 00818053027277 F201100061 PRES0203CXPPL Prestige Coil 2mm x 3cm Prestige Plus Complex Xtra Pac 00818053027314 F201100062 PRES0204CXPPL Prestige Coil 2mm x 4cm Prestige Plus Complex Xtra Pac 00818053027321 F201100063 PRES0517CPKPL Prestige Coil 5mm x 17cm Prestige Plus Complex Pack 00818053027505 F201100064 PRES0615CPKPL Prestige Coil 6mm x 15cm Prestige Plus Complex Pack 00818053027529 F201100065 PRES0830CPKPL Prestige Coil 8mm x 30cm Prestige Plus Complex Pack 00818053027574 F201100066 PRES0101HXPPL Prestige Coil 1mm x 1cm Prestige Plus Helical Xtra Pac 00818053027109 F201100067 PRES0101CXPPL Prestige Coil 1mm x 1cm Prestige Plus Complex Xtra Pac 00818053027253 F201100132 PRES0306HPK10 Prestige Coil 3mm x 6cm Helical-10 Pack 00818053024153 F201100133 PRES0308HPK10 Prestige Coil 3mm x 8cm Helical-10 Pack 00818053024160 F201100134 PRES0310HPK10 Prestige Coil 3mm x 10cm Helical-10 Pack 00818053024177 F201100135 PRES0508HPK10 Prestige Coil 5mm x 8cm Helical-10 Pack 00818053024221 F201100136 PRES0930HRG10 Prestige Coil 9mm x 30cm Helical-10 Regular 00818053024337 F201100137 PRES0101CXPPL Prestige Coil 1mm x 1cm Prestige Plus Complex Xtra Pac 00818053027253 F201100138 PRES0153HXPPL Prestige Coil 1.5mm x 3cm Prestige Plus Helical Xtra Pac 00818053027147 F201100139 PRES1040HPKPL Prestige Coil 10mm x 40cm Prestige Plus Helical Pack 00818053027246 F201100229 PRES0615HRG10 Prestige Coil 6mm x 15cm Helical-10 Regular 00818053024276 F201100247 PRES1447COM18 Prestige Coil 14mm x 47cm Complex-18 00818053023248 F201100248 PRES1860COM18 Prestige Coil 18mm x 60cm Complex-18 00818053023279 F201100249 PRES0102CXPPL Prestige Coil 1mm x 2cm Prestige Plus Complex Xtra Pac 00818053027260 F201100250 PRES0413CPKPL Prestige Coil 4mm x 13cm Prestige Plus Complex Pack 00818053027451 F201100253 PRES0510CPKPL Prestige Coil 5mm x 10cm Prestige Plus Complex Pack 00818053027499 F201100255 PRES0517CPKPL Prestige Coil 5mm x 17cm Prestige Plus Complex Pack 00818053027505 F201100257 PRES0103HXPPL Prestige Coil 1mm x 3cm Prestige Plus Helical Xtra Pac 00818053027123 F201100258 PRES0620HPKPL Prestige Coil 6mm x 20cm Prestige Plus Helical Pack 00818053027208 F201100266 PRES0308HPK10 Prestige Coil 3mm x 8cm Helical-10 Pack 00818053024160 F201100267 PRES0720HPKPL Prestige Coil 7mm x 20cm Prestige Plus Helical Pack 00818053027215 F201100268 PRES0620HRG10 Prestige Coil 6mm x 20cm Helical-10 Regular 00818053024283 F201100291 PRES0720CPKPL Prestige Coil 7mm x 20cm Prestige Plus Complex Pack 00818053027550 F201100296 PRES0510HPK10 Prestige Coil 5mm x 10cm Helical-10 Pack 00818053024238 F201100297 PRES2065COM18 Prestige Coil 20mm x 65cm Complex-18 00818053023286 F201100320 PRES1447COM18 Prestige Coil 14mm x 47cm Complex-18 00818053023248 F201100321 PRES2465COM18 Prestige Coil 24mm x 65cm Complex-18 00818053023309 F201100403 PRES0420HPKPL Prestige Coil 4mm x 20cm Prestige Plus Helical Pack 00818053027185 F201100404 PRES0520HPKPL Prestige Coil 5mm x 20cm Prestige Plus Helical Pack 00818053027192 F201100405 PRES0720HPKPL Prestige Coil 7mm x 20cm Prestige Plus Helical Pack 00818053027215 F201100412 PRES0412CXP10 Prestige Coil 4mm x 12cm Complex-10 Xtra Pack 00818053027628 F201100499 PRES0307CXPPL Prestige Coil 3mm x 7cm Prestige Plus Complex Xtra Pac 00818053027376 F201200013 PRES0304HPK10 Prestige Coil 3mm x 4cm Helical-10 Pack 00818053024146 F201200015 PRES0204HXP10 Prestige Coil 2mm x 4cm Helical-10 Xtra Pack 00818053023989 F201200016 PRES0413CPKPL Prestige Coil 4mm x 13cm Prestige Plus Complex Pack 00818053027451 F201200017 PRES0720CPKPL Prestige Coil 7mm x 20cm Prestige Plus Complex Pack 00818053027550 F201200018 PRES0930CPKPL Prestige Coil 9mm x 30cm Prestige Plus Complex Pack 00818053027581 F201200019 PRES0620HPKPL Prestige Coil 6mm x 20cm Prestige Plus Helical Pack 00818053027208 F201200020 PRES0206HXP10 Prestige Coil 2mm x 6cm Helical-10 Xtra Pack 00818053023996 F201200377 PRES1655COM18 Prestige Coil 16mm x 55cm Complex-18 00818053023262 F201200378 PRES1860COM18 Prestige Coil 18mm x 60cm Complex-18 00818053023279 F201200765 PRES0408HPK10 Prestige Coil 4mm x 8cm Helical-10 Pack 00818053024191 F201200766 PRES0303CXPPL Prestige Coil 3mm x 3cm Prestige Plus Complex Xtra Pac 00818053027369 F201200767 PRES0407CPKPL Prestige Coil 4mm x 7cm Prestige Plus Complex Pack 00818053027437 F201200768 PRES4510CPKPL Prestige Coil 4.5mm x 10cm Prestige Plus Complex Pack 00818053027475 F201200771 PRES0204HXPPL Prestige Coil 2mm x 4cm Prestige Plus Helical Xtra Pac 00818053029943 F201200772 PRES0208HXPPL Prestige Coil 2mm x 8cm Prestige Plus Helical Xtra Pac 00818053029981 F201200773 PRES0515HPKPL Prestige Coil 5mm x 15cm Prestige Plus Helical Pack 00818053029684 F201200789 PRES1030HRG10 Prestige Coil 10mm x 30cm Helical-10 Regular 00818053024344 F201200920 PRES1240COM18 Prestige Coil 12mm x 40cm Complex-18 00818053023224 F201200921 PRES1655COM18 Prestige Coil 16mm x 55cm Complex-18 00818053023262 F201200922 PRES0204HXP10 Prestige Coil 2mm x 4cm Helical-10 Xtra Pack 00818053023989 F201200923 PRES0206HXP10 Prestige Coil 2mm x 6cm Helical-10 Xtra Pack 00818053023996 F201200924 PRES0608HPK10 Prestige Coil 6mm x 8cm Helical-10 Pack 00818053024252 F201200925 PRES0730HRG10 Prestige Coil 7mm x 30cm Helical-10 Regular 00818053024306 F201200926 PRES0930HRG10 Prestige Coil 9mm x 30cm Helical-10 Regular 00818053024337 F201200927 PRES0358CXPPL Prestige Coil 3.5mm x 8cm Prestige Plus Complex Xtra Pac 00818053027413 F201201093 PRES0304HPK10 Prestige Coil 3mm x 4cm Helical-10 Pack 00818053024146 F201201095 PRES0255HXPPL Prestige Coil 2.5mm x 5cm Prestige Plus Helical Xtra Pac 00818053027161 F201201101 PRES0720HRG10 Prestige Coil 7mm x 20cm Helical-10 Regular 00818053024290 F201201102 PRES1030HRG10 Prestige Coil 10mm x 30cm Helical-10 Regular 00818053024344 F201201103 PRES0202CXPPL Prestige Coil 2mm x 2cm Prestige Plus Complex Xtra Pac 00818053027307 F201201104 PRES0517CPKPL Prestige Coil 5mm x 17cm Prestige Plus Complex Pack 00818053027505 F201201105 PRES0101HXPPL Prestige Coil 1mm x 1cm Prestige Plus Helical Xtra Pac 00818053027109 F201201106 PRES0206HXPPL Prestige Coil 2mm x 6cm Prestige Plus Helical Xtra Pac 00818053029967 F201201107 PRES0310HXPPL Prestige Coil 3mm x 10cm Prestige Plus Helical Xtra Pac 00810068560060 F201201108 PRES0315HXPPL Prestige Coil 3mm x 15cm Prestige Plus Helical Xtra Pac 00818053027178 F201201109 PRES0410HPKPL Prestige Coil 4mm x 10cm Prestige Plus Helical Pack 00818053029646 F201201110 PRES0608HPK10 Prestige Coil 6mm x 8cm Helical-10 Pack 00818053024252 F201201111 PRES0407CPKPL Prestige Coil 4mm x 7cm Prestige Plus Complex Pack 00818053027437 F201201112 PRES1030CPKPL Prestige Coil 10mm x 30cm Prestige Plus Complex Pack 00818053029745 F201201113 PRES0255HXPPL Prestige Coil 2.5mm x 5cm Prestige Plus Helical Xtra Pac 00818053027161 F210100021 PRES0408HPK10 Prestige Coil 4mm x 8cm Helical-10 Pack 00818053024191 F210100022 PRES0608HPK10 Prestige Coil 6mm x 8cm Helical-10 Pack 00818053024252 F210100023 PRES0830HRG10 Prestige Coil 8mm x 30cm Helical-10 Regular 00818053024320 F210100024 PRES0404CPKPL Prestige Coil 4mm x 4cm Prestige Plus Complex Pack 00818053027420 F210100025 PRES0255HXPPL Prestige Coil 2.5mm x 5cm Prestige Plus Helical Xtra Pac 00818053027161 F210100026 PRES0204HXP10 Prestige Coil 2mm x 4cm Helical-10 Xtra Pack 00818053023989 F210100027 PRES0304HPK10 Prestige Coil 3mm x 4cm Helical-10 Pack 00818053024146 F210100028 PRES0410HPK10 Prestige Coil 4mm x 10cm Helical-10 Pack 00818053024207 F210100029 PRES0510HPK10 Prestige Coil 5mm x 10cm Helical-10 Pack 00818053024238 F210100030 PRES0255CXPPL Prestige Coil 2.5mm x 5cm Prestige Plus Complex Xtra Pac 00818053027352 F210100032 PRES0103HXPPL Prestige Coil 1mm x 3cm Prestige Plus Helical Xtra Pac 00818053027123 F210100033 PRES0515HPKPL Prestige Coil 5mm x 15cm Prestige Plus Helical Pack 00818053029684 F210100475 PRES0308HPK10 Prestige Coil 3mm x 8cm Helical-10 Pack 00818053024160 F210100476 PRES0408HPK10 Prestige Coil 4mm x 8cm Helical-10 Pack 00818053024191 F210100477 PRES0410HPK10 Prestige Coil 4mm x 10cm Helical-10 Pack 00818053024207 F210100478 PRES0510HPK10 Prestige Coil 5mm x 10cm Helical-10 Pack 00818053024238 F210100479 PRES0610HPK10 Prestige Coil 6mm x 10cm Helical-10 Pack 00818053024269 F210100480 PRES0730HRG10 Prestige Coil 7mm x 30cm Helical-10 Regular 00818053024306 F210100481 PRES1030HRG10 Prestige Coil 10mm x 30cm Helical-10 Regular 00818053024344 F210100482 PRES4510CPKPL Prestige Coil 4.5mm x 10cm Prestige Plus Complex Pack 00818053027475 F210100483 PRES0517CPKPL Prestige Coil 5mm x 17cm Prestige Plus Complex Pack 00818053027505 F210100484 PRES0820CPKPL Prestige Coil 8mm x 20cm Prestige Plus Complex Pack 00818053027567 F210100485 PRES1030CPKPL Prestige Coil 10mm x 30cm Prestige Plus Complex Pack 00818053029745 F210100486 PRES0206HXPPL Prestige Coil 2mm x 6cm Prestige Plus Helical Xtra Pac 00818053029967 F210100487 PRES0208HXPPL Prestige Coil 2mm x 8cm Prestige Plus Helical Xtra Pac 00818053029981 F210100488 PRES0255HXPPL Prestige Coil 2.5mm x 5cm Prestige Plus Helical Xtra Pac 00818053027161 F210100489 PRES0310HXPPL Prestige Coil 3mm x 10cm Prestige Plus Helical Xtra Pac 00810068560060 F210100490 PRES0315HXPPL Prestige Coil 3mm x 15cm Prestige Plus Helical Xtra Pac 00818053027178 F210100491 PRES0410HPKPL Prestige Coil 4mm x 10cm Prestige Plus Helical Pack 00818053029646 F210100492 PRES0420HPKPL Prestige Coil 4mm x 20cm Prestige Plus Helical Pack 00818053027185 F210100493 PRES0515HPKPL Prestige Coil 5mm x 15cm Prestige Plus Helical Pack 00818053029684 F210100494 PRES0520HPKPL Prestige Coil 5mm x 20cm Prestige Plus Helical Pack 00818053027192 F210100495 PRES0620HPKPL Prestige Coil 6mm x 20cm Prestige Plus Helical Pack 00818053027208 F210100496 PRES0720HPKPL Prestige Coil 7mm x 20cm Prestige Plus Helical Pack 00818053027215 F210100497 PRES0830HPKPL Prestige Coil 8mm x 30cm Prestige Plus Helical Pack 00818053027222 F210100498 PRES0930HPKPL Prestige Coil 9mm x 30cm Prestige Plus Helical Pack 00818053027239 F210100499 PRES1040HPKPL Prestige Coil 10mm x 40cm Prestige Plus Helical Pack 00818053027246 F210100500 PRES0153CXPPL Prestige Coil 1.5mm x 3cm Prestige Plus Complex Xtra Pac 00818053027291 F210100901 PRES0202CXPPL Prestige Coil 2mm x 2cm Prestige Plus Complex Xtra Pac 00818053027307 F210100902 PRES0255CXPPL Prestige Coil 2.5mm x 5cm Prestige Plus Complex Xtra Pac 00818053027352 F210100903 PRES0303CXPPL Prestige Coil 3mm x 3cm Prestige Plus Complex Xtra Pac 00818053027369 F210100904 PRES0310CXPPL Prestige Coil 3mm x 10cm Prestige Plus Complex Xtra Pac 00818053027383 F210100905 PRES0355CXPPL Prestige Coil 3.5mm x 5cm Prestige Plus Complex Xtra Pac 00818053027406 F210100935 PRES0615HRG10 Prestige Coil 6mm x 15cm Helical-10 Regular 00818053024276 F210100936 PRES0203CXPPL Prestige Coil 2mm x 3cm Prestige Plus Complex Xtra Pac 00818053027314 F210100937 PRES0410CPKPL Prestige Coil 4mm x 10cm Prestige Plus Complex Pack 00818053027444 F210100938 PRES0413CPKPL Prestige Coil 4mm x 13cm Prestige Plus Complex Pack 00818053027451 F210100939 PRES0510CPKPL Prestige Coil 5mm x 10cm Prestige Plus Complex Pack 00818053027499 F210100940 PRES0620CPKPL Prestige Coil 6mm x 20cm Prestige Plus Complex Pack 00818053027536 F210100941 PRES0204HXPPL Prestige Coil 2mm x 4cm Prestige Plus Helical Xtra Pac 00818053029943 F210100942 PRES0410HPKPL Prestige Coil 4mm x 10cm Prestige Plus Helical Pack 00818053029646 F210100943 PRES0720HPKPL Prestige Coil 7mm x 20cm Prestige Plus Helical Pack 00818053027215 F210200379 PRES0720HRG10 Prestige Coil 7mm x 20cm Helical-10 Regular 00818053024290 F210200380 PRES0830HRG10 Prestige Coil 8mm x 30cm Helical-10 Regular 00818053024320 F210200382 PRES0101CXPPL Prestige Coil 1mm x 1cm Prestige Plus Complex Xtra Pac 00818053027253 F210200383 PRES0102CXPPL Prestige Coil 1mm x 2cm Prestige Plus Complex Xtra Pac 00818053027260 F210200384 PRES0103CXPPL Prestige Coil 1mm x 3cm Prestige Plus Complex Xtra Pac 00818053027277 F210200385 PRES0202CXPPL Prestige Coil 2mm x 2cm Prestige Plus Complex Xtra Pac 00818053027307 F210200386 PRES0206CXPPL Prestige Coil 2mm x 6cm Prestige Plus Complex Xtra Pac 00818053027338 F210200387 PRES0307CXPPL Prestige Coil 3mm x 7cm Prestige Plus Complex Xtra Pac 00818053027376 F210200388 PRES0355CXPPL Prestige Coil 3.5mm x 5cm Prestige Plus Complex Xtra Pac 00818053027406 F210200389 PRES0358CXPPL Prestige Coil 3.5mm x 8cm Prestige Plus Complex Xtra Pac 00818053027413 F210200390 PRES1040CPKPL Prestige Coil 10mm x 40cm Prestige Plus Complex Pack 00818053027598 F210200391 PRES0153HXPPL Prestige Coil 1.5mm x 3cm Prestige Plus Helical Xtra Pac 00818053027147 F210200440 PRES0820HRG10 Prestige Coil 8mm x 20cm Helical-10 Regular 00818053024313 F210200457 PRES0620HRG10 Prestige Coil 6mm x 20cm Helical-10 Regular 00818053024283 F210200460 PRES0413CPKPL Prestige Coil 4mm x 13cm Prestige Plus Complex Pack 00818053027451 F210200539 PRES0407CPKPL Prestige Coil 4mm x 7cm Prestige Plus Complex Pack 00818053027437 F210300005 PRES0830CPKPL Prestige Coil 8mm x 30cm Prestige Plus Complex Pack 00818053027574 F210300007 PRES0410CPKPL Prestige Coil 4mm x 10cm Prestige Plus Complex Pack 00818053027444 F210300017 PRES0202CXPPL Prestige Coil 2mm x 2cm Prestige Plus Complex Xtra Pac 00818053027307 F210300024 PRES0830CPKPL Prestige Coil 8mm x 30cm Prestige Plus Complex Pack 00818053027574 F210300104 PRES0930HRG10 Prestige Coil 9mm x 30cm Helical-10 Regular 00818053024337 F210300177 PRES0310CXPPL Prestige Coil 3mm x 10cm Prestige Plus Complex Xtra Pac 00818053027383 F210300183 PRES1030CPKPL Prestige Coil 10mm x 30cm Prestige Plus Complex Pack 00818053029745 F210300185 PRES0410HPKPL Prestige Coil 4mm x 10cm Prestige Plus Helical Pack 00818053029646 F210300381 PRES0208HXPPL Prestige Coil 2mm x 8cm Prestige Plus Helical Xtra Pac 00818053029981 F210601079 PRES0520HPKPL Prestige Coil 5mm x 20cm Prestige Plus Helical Pack 00818053027192 F230601801 PRES1655COM18 Prestige Coil 16mm x 55cm Complex-18 00840303708094 F230601818 PRES2065COM18 Prestige Coil 20mm x 65cm Complex-18 00840303708117 F230601877 PRES1447COM18 Prestige Coil 14mm x 47cm Complex-18 00840303708070 F230602699 PRES2465COM18 Prestige Coil 24mm x 65cm Complex-18 00840303708131 F230602711 PRES1860COM18 Prestige Coil 18mm x 60cm Complex-18 00840303708100 F230604171 PRES2265COM18 Prestige Coil 22mm x 65cm Complex-18 00840303708124 F230604173 PRES1860COM18 Prestige Coil 18mm x 60cm Complex-18 00840303708100 F230604175 PRES2065COM18 Prestige Coil 20mm x 65cm Complex-18 00840303708117 F230604374 PRES2465COM18 Prestige Coil 24mm x 65cm Complex-18 00840303708131 F230605423 PRES2265COM18 Prestige Coil 22mm x 65cm Complex-18 00840303708124 F230605479 PRES1447COM18 Prestige Coil 14mm x 47cm Complex-18 00840303708070 F230605542 PRES1655COM18 Prestige Coil 16mm x 55cm Complex-18 00840303708094 F230605560 PRES2265COM18 Prestige Coil 22mm x 65cm Complex-18 00840303708124 F230700403 PRES1240COM18 Prestige Coil 12mm x 40cm Complex-18 00840303708056 F230700467 PRES0827COM18 Prestige Coil 8mm x 27cm Complex-18 00840303708018 F230700759 PRES1034COM18 Prestige Coil 10mm x 34cm Complex-18 00840303708032 F230700883 PRES1034COM18 Prestige Coil 10mm x 34cm Complex-18 00840303708032 F231100604 PRES0152CXPPL Prestige Coil 1.5mm x 2cm Prestige Plus Complex Xtra Pac 00818053027284
Recalling Firm/
Manufacturer		 BALT USA, LLC
29 Parker Ste 100
Irvine CA 92618-1667
For Additional Information Contact Mr. David Vu
949-788-1443
Manufacturer Reason
for Recall		 Discoloration was identified along the delivery pusher which was attributed to corrosion of the hypotube. The material which caused the corrosion was identified as remnants of solder flux residue remaining on the hypotube component of the delivery pusher. Due to the location of the delivery pusher within the delivery system, it is possible for the discoloration to mechanically break off from the delivery pusher, leaving the potential for the material to flow through the delivery system (i.e. microcatheter), and into the patient vasculature causing foreign emboli.
FDA Determined
Cause 2		 Material/Component Contamination
Action On 01/03/2024, the firm sent an "URGENT: MEDICAL DEVICE RECALL" Letter via priority mail to customers informing them that Balt USA has became aware of a situation where discoloration along the delivery system pusher component of the Optima Coil System was identified during in-house inspection of released finished good products. The discoloration was observed on the outside of the PET jacket along the hypotube component. Customers are instructed to: 1) Stop or cease use of the affected recall product. 2) Inform their hospital staff, such as safety officers, pharmacists, purchasing agent, head of neuroradiology and the neuroradiology staff, physicians including but not limited to endovascular neurosurgeons and interventional neurologists, as well as any other person if deemed necessary of the recall. 3) Identify and locate the Optima Coil System products concerned by this recall procedure. 4) Collect and put in quarantine the Optima Coil System products concerned by this recall procedure, then return them to Balt USA through the usual RGA (Return Goods Authorization) procedure by contacting Balt USA s Customer Service department. 5) Keep informed by Balt USA about the status of every unit of Optima Coil System products concerned by this recall procedure. For questions or additional assistance, contact Balt USA Quality Department at: Contact: Quality Department email: QA@baltgroup.com Balt USA, LLC 29 Parker | Irvine CA, 92618 | USA Telephone: +1 949.788.1443 | Fax: +1 949.788.1444
Quantity in Commerce 2802 coils
Distribution U.S.: AZ, CA, CO, FL, GA, HI, IL, KS, MA, ME, MO, MS, NC, NE, NH, NJ, NY, OH, OK, PA, SC, SD, TN, TX, VA, VT, WI and Puerto Rico O.U.S.: Argentina, Australia, Brazil, Canada, Chile, Columbia, Dominican Republic, Ecuador, France, Indonesia, India, Japan, Korea, Malaysia, Mexico, Panama, Paraguay, Peru, Russia, Uruguay, and Vietnam.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database 510(K)s with Product Code = KRD and Original Applicant = Bait USA, LLC
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