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U.S. Department of Health and Human Services

Class 2 Device Recall Optima Coil System

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 Class 2 Device Recall Optima Coil Systemsee related information
Date Initiated by FirmMay 08, 2025
Date PostedJune 18, 2025
Recall Status1 Open3, Classified
Recall NumberZ-1988-2025
Recall Event ID 96787
510(K)NumberK172390 K200030 
Product Classification Device, neurovascular embolization - Product Code HCG
ProductOptima Coil System REFs/UDI-DI codes: OPTI0156BLK 00810068568875 OPTI0158BLK 00810068568882 OPTI0103BLK 00810068568851 OPTI0258BLK 00810068568929 OPTI0212BLK 00810068568912 OPTI0206BLK 00810068568905 OPTI0310BLK 00810068568943 OPTI0320BLK 00810068568950 OPTI0151HSS10 00818053026614 OPTI0152HSS10 00840303701002 OPTI0153HSS10 00840303701019 OPTI0154CSS10 00818053025761 OPTI0154HSS10 00840303701026 OPTI1027CST10 00840303700142 OPTI1030HST10 00818053027086 OPTI1034COM18 00818053026461 OPTI1137COM18 00818053026478 OPTI1550COM18 00818053026515 OPTI0101CSS10 00818053025709 OPTI0101HSS10 00840303700951 OPTI0102CSS10 00818053025716 OPTI0102HSS10 00840303700968 OPTI0103HSS10 00818053026591 OPTI0103CSS10 00818053025723 OPTI0104HSS10 00818053026607 OPTI0254CSS10 00840303700548 OPTI0255CSF10 00840303700203 OPTI0256CSS10 00818053025853 OPTI0256HSS10 00818053026737 OPTI0202HSS10 00840303701040 OPTI0203HSS10 00840303701057 OPTI0203CSS10 00818053025785 OPTI0204CSS10 00840303700494 OPTI0204HSS10 00840303701064 OPTI0206CSF10 00818053026027 OPTI0206CSS10 00818053025808 OPTI0208CSF10 00818053026034 OPTI0208HSS10 00840303701088 OPTI0208CSS10 00840303700517 OPTI0358CSS10 00818053025921 OPTI0310HSS10 00840303701156 OPTI0310CSS10 00818053025907 OPTI0310HSF10 00840303700814 OPTI0310CSF10 00840303700234 OPTI0304HSS10 00840303701125 OPTI0304HSF10 00840303700784 OPTI0304CSS10 00818053025877 OPTI0306HSS10 00840303701132 OPTI0308HSS10 00840303701149 OPTI0308CSF10 00818053026065 OPTI0308CSS10 00840303700593 OPTI0410CSS10 00840303700654 OPTI0410HSF10 00840303700852 OPTI0413CSF10 00818053026119 OPTI0406HSS10 00840303701163 OPTI0408HSS10 00818053026799 OPTI0413CST10 00840303700036 OPTI0510HSS10 00840303701217 OPTI0510CSS10 00840303700685 OPTI0510HSF10 00840303700890 OPTI0513CSS10 00840303700692 OPTI0517CSF10 00818053026157 OPTI0517CST10 00840303700050 OPTI0508CSS10 00840303700678 OPTI0509CSF10 00818053026140 OPTI0610HSF10 00840303700937 OPTI0611CSF10 00818053026171 OPTI0620CSF10 00840303700357 OPTI0620HST10 00840303700715 OPTI0713CST10 00840303700081 OPTI0713CSF10 00840303700364 OPTI0724CSF10 00818053026218 OPTI0724CST10 00840303700098 OPTI0724COM18 00818053026430 OPTI0827CSF10 00818053026232 OPTI0827CST10 00840303700111 OPTI0923CST10 00818053026379 OPTI0930COM18 00818053026454 OPTI0153HSSMX 00818053025419 OPTI1040CSFMX 00818053025280 OPTI1245CSFMX 00818053025303 OPTI1445CSFMX 00818053025327 OPTI1650CSFMX 00818053025341 OPTI0103CSSMX 00840303701408 OPTI2525CSSMX 00840303701477 OPTI0255CSSMX 00818053025020 OPTI0202CSSMX 00818053024979 OPTI3535CSSMX 00818053025068 OPTI0310CSSMX 00818053025051 OPTI0307CSSMX 00818053025044 OPTI4510CSFMX 00818053025143 OPTI4545CSFMX 00818053025136 OPTI0413CSFMX 00818053025129 OPTI0404CSFMX 00818053025099 OPTI0407CSFMX 00818053025105 OPTI0510CSFMX 00818053025167 OPTI0507CSFMX 00818053025150 OPTI0715CSFMX 00818053025228 OPTI0720CSFMX 00818053025235 OPTI0930CSFMX 00818053025266 The Optima Coil System consists of an implantable embolization coil comprised of a platinum-tungsten alloy attached to a proximal stainless steel hypotube and distal body coil delivery pusher with a radiopaque distal positioning marker and a proximal fluorosafe marker. The Optima Coil delivery pusher is 185cm in length. It is designed for use with the XCEL Detachment Controller. The XCEL Detachment Controller comes pre-loaded with batteries and is a sterile, handheld, single patient-use device which should not be reused, re-sterilized, opened or tampered with. The Optima Coil achieves detachment by an internal heater element, which is powered by the XCEL Detachment Controller. The Optima Coil System and XCEL Detachment Controller(s) are sold separately.
Code Information Product Description/Product Catalog Number/UDI-DI/Lot Numbers: OptiBLOCK Coil 1.5mm x 6cm OptiBLOCK Complex OPTI0156BLK 00810068568875 F230800439 OptiBLOCK Coil 1.5mm x 6cm OptiBLOCK Complex OPTI0156BLK 00810068568875 F230800506 OptiBLOCK Coil 1.5mm x 6cm OptiBLOCK Complex OPTI0156BLK 00810068568875 F230800507 OptiBLOCK Coil 1.5mm x 6cm OptiBLOCK Complex OPTI0156BLK 00810068568875 F230800579 OptiBLOCK Coil 1.5mm x 6cm OptiBLOCK Complex OPTI0156BLK 00810068568875 F230800885 OptiBLOCK Coil 1.5mm x 8cm OptiBLOCK Complex OPTI0158BLK 00810068568882 F230800480 OptiBLOCK Coil 1.5mm x 8cm OptiBLOCK Complex OPTI0158BLK 00810068568882 F230800581 OptiBLOCK Coil 1.5mm x 8cm OptiBLOCK Complex OPTI0158BLK 00810068568882 F230800722 OptiBLOCK Coil 1.5mm x 8cm OptiBLOCK Complex OPTI0158BLK 00810068568882 F230800857 OptiBLOCK Coil 1.5mm x 8cm OptiBLOCK Complex OPTI0158BLK 00810068568882 F230800858 OptiBLOCK Coil 1mm x 3cm OptiBLOCK Complex OPTI0103BLK 00810068568851 F230800854 OptiBLOCK Coil 1mm x 3cm OptiBLOCK Complex OPTI0103BLK 00810068568851 F230800855 OptiBLOCK Coil 2.5mm x 8cm OptiBLOCK Complex OPTI0258BLK 00810068568929 F230800768 OptiBLOCK Coil 2mm x 12cm OptiBLOCK Complex OPTI0212BLK 00810068568912 F230800514 OptiBLOCK Coil 2mm x 12cm OptiBLOCK Complex OPTI0212BLK 00810068568912 F230800525 OptiBLOCK Coil 2mm x 12cm OptiBLOCK Complex OPTI0212BLK 00810068568912 F230800577 OptiBLOCK Coil 2mm x 12cm OptiBLOCK Complex OPTI0212BLK 00810068568912 F230800770 OptiBLOCK Coil 2mm x 12cm OptiBLOCK Complex OPTI0212BLK 00810068568912 F230800887 OptiBLOCK Coil 2mm x 6cm OptiBLOCK Complex OPTI0206BLK 00810068568905 F230800478 OptiBLOCK Coil 3mm x 10cm OptiBLOCK Complex OPTI0310BLK 00810068568943 F230800497 OptiBLOCK Coil 3mm x 20cm OptiBLOCK Complex OPTI0320BLK 00810068568950 F230800760 OptiBLOCK Coil 3mm x 20cm OptiBLOCK Complex OPTI0320BLK 00810068568950 F230800856 Optima Coil 1.5mm x 1cm Helical-10 SuperSoft OPTI0151HSS10 00818053026614 F230800784 Optima Coil 1.5mm x 2cm Helical-10 SuperSoft OPTI0152HSS10 00840303701002 F230800453 Optima Coil 1.5mm x 2cm Helical-10 SuperSoft OPTI0152HSS10 00818053026621 F230800452 Optima Coil 1.5mm x 2cm Helical-10 SuperSoft OPTI0152HSS10 00818053026621 F230800542 Optima Coil 1.5mm x 2cm Helical-10 SuperSoft OPTI0152HSS10 00818053026621 F230800543 Optima Coil 1.5mm x 2cm Helical-10 SuperSoft OPTI0152HSS10 00818053026621 F230800801 Optima Coil 1.5mm x 2cm Helical-10 SuperSoft OPTI0152HSS10 00818053022135 F230900938 Optima Coil 1.5mm x 3cm Helical-10 SuperSoft OPTI0153HSS10 00840303701019 F230800521 Optima Coil 1.5mm x 3cm Helical-10 SuperSoft OPTI0153HSS10 00818053026638 F230800496 Optima Coil 1.5mm x 4cm Complex-10 SuperSoft OPTI0154CSS10 00818053025761 F230800679 Optima Coil 1.5mm x 4cm Complex-10 SuperSoft OPTI0154CSS10 00818053025761 F230800762 Optima Coil 1.5mm x 4cm Helical-10 SuperSoft OPTI0154HSS10 00840303701026 F230800813 Optima Coil 1.5mm x 4cm Complex-10 SuperSoft OPTI0154CSS10 00818053025761 F230800852 Optima Coil 1.5mm x 4cm Complex-10 SuperSoft OPTI0154CSS10 00818053025761 F230900011 Optima Coil 10mm x 27cm Complex- 10 Standard OPTI1027CST10 00840303700142 F230800522 Optima Coil 10mm x 30cm Helical-10 Standard OPTI1030HST10 00818053027086 F230800668 Optima Coil 10mm x 30cm Helical-10 Standard OPTI1030HST10 00818053027086 F230800772 Optima Coil 10mm x 34cm Complex-18 OPTI1034COM18 00818053026461 F230800823 Optima Coil 10mm x 34cm Complex-18 OPTI1034COM18 00818053026461 F230800955 Optima Coil 10mm x 34cm Complex-18 OPTI1034COM18 00818053021978 F230900979 Optima Coil 11mm x 37cm Complex-18 OPTI1137COM18 00818053026478 F230800895 Optima Coil 11mm x 37cm Complex-18 OPTI1137COM18 00818053026478 F240500725 Optima Coil 15mm x 50cm Complex-18 OPTI1550COM18 00818053026515 F230800463 Optima Coil 15mm x 50cm Complex-18 OPTI1550COM18 00818053022029 F230900419 Optima Coil 1mm x 1cm Complex-10 SuperSoft OPTI0101CSS10 00818053025709 F230800449 Optima Coil 1mm x 1cm Complex-10 SuperSoft OPTI0101CSS10 00818053025709 F230800540 Optima Coil 1mm x 1cm Complex-10 SuperSoft OPTI0101CSS10 00818053025709 F230800824 Optima Coil 1mm x 1cm Helical-10 SuperSoft OPTI0101HSS10 00840303700951 F230800960 Optima Coil 1mm x 2cm Complex-10 SuperSoft OPTI0102CSS10 00818053025716 F230800562 Optima Coil 1mm x 2cm Complex-10 SuperSoft OPTI0102CSS10 00818053025716 F230800692 Optima Coil 1mm x 2cm Helical-10 SuperSoft OPTI0102HSS10 00840303700968 F230800700 Optima Coil 1mm x 2cm Complex-10 SuperSoft OPTI0102CSS10 00818053021381 F230900932 Optima Coil 1mm x 3cm Helical-10 SuperSoft OPTI0103HSS10 00818053026591 F230800455 Optima Coil 1mm x 3cm Helical-10 SuperSoft OPTI0103HSS10 00818053026591 F230800456 Optima Coil 1mm x 3cm Helical-10 SuperSoft OPTI0103HSS10 00818053026591 F230800457 Optima Coil 1mm x 3cm Helical-10 SuperSoft OPTI0103HSS10 00818053026591 F230800532 Optima Coil 1mm x 3cm Complex-10 SuperSoft OPTI0103CSS10 00818053025723 F230800942 Optima Coil 1mm x 3cm Complex-10 SuperSoft OPTI0103CSS10 00818053025723 F230800967 Optima Coil 1mm x 3cm Helical-10 SuperSoft OPTI0103HSS10 00818053022104 F230900935 Optima Coil 1mm x 4cm Helical-10 SuperSoft OPTI0104HSS10 00818053026607 F230800717 Optima Coil 1mm x 4cm Helical-10 SuperSoft OPTI0104HSS10 00818053026607 F230800719 Optima Coil 1mm x 4cm Helical-10 SuperSoft OPTI0104HSS10 00818053026607 F230800866 Optima Coil 2.5mm x 4cm Complex-10 SuperSoft OPTI0254CSS10 00840303700548 F230800561 Optima Coil 2.5mm x 4cm Complex-10 SuperSoft OPTI0254CSS10 00840303700548 F230800757 Optima Coil 2.5mm x 5cm Complex-10 Soft OPTI0255CSF10 00840303700203 F230800466 Optima Coil 2.5mm x 6cm Complex-10 SuperSoft OPTI0256CSS10 00818053025853 F230800554 Optima Coil 2.5mm x 6cm Complex-10 SuperSoft OPTI0256CSS10 00818053025853 F230800555 Optima Coil 2.5mm x 6cm Complex-10 SuperSoft OPTI0256CSS10 00818053025853 F230800556 Optima Coil 2.5mm x 6cm Complex-10 SuperSoft OPTI0256CSS10 00818053025853 F230800559 Optima Coil 2.5mm x 6cm Complex-10 SuperSoft OPTI0256CSS10 00818053025853 F230800685 Optima Coil 2.5mm x 6cm Complex-10 SuperSoft OPTI0256CSS10 00818053025853 F230800686 Optima Coil 2.5mm x 6cm Complex-10 SuperSoft OPTI0256CSS10 00818053025853 F230800694 Optima Coil 2.5mm x 6cm Helical-10 SuperSoft OPTI0256HSS10 00818053026737 F230800725 Optima Coil 2.5mm x 6cm Helical-10 SuperSoft OPTI0256HSS10 00840303701118 F230800726 Optima Coil 2.5mm x 6cm Helical-10 SuperSoft OPTI0256HSS10 00818053026737 F230800816 Optima Coil 2.5mm x 6cm Helical-10 SuperSoft OPTI0256HSS10 00840303701118 F230800817 Optima Coil 2.5mm x 6cm Complex-10 SuperSoft OPTI0256CSS10 00818053025853 F230800859 Optima Coil 2.5mm x 6cm Complex-10 SuperSoft OPTI0256CSS10 00818053025853 F230900016 Optima Coil 2.5mm x 6cm Helical-10 SuperSoft OPTI0256HSS10 00818053026737 F230900026 Optima Coil 2.5mm x 6cm Complex-10 SuperSoft OPTI0256CSS10 00818053021510 F230900958 Optima Coil 2.5mm x 6cm Complex-10 SuperSoft OPTI0256CSS10 00818053021510 F230900960 Optima Coil 2.5mm x 6cm Complex-10 SuperSoft OPTI0256CSS10 00818053025853 F240500687 Optima Coil 2mm x 2cm Helical-10 SuperSoft OPTI0202HSS10 00840303701040 F230800764 Optima Coil 2mm x 2cm Helical-10 SuperSoft OPTI0202HSS10 00818053026669 F230800765 Optima Coil 2mm x 2cm Helical-10 SuperSoft OPTI0202HSS10 00818053022173 F230900945 Optima Coil 2mm x 3cm Helical-10 SuperSoft OPTI0203HSS10 00840303701057 F230800573 Optima Coil 2mm x 3cm Complex-10 SuperSoft OPTI0203CSS10 00818053025785 F230800678 Optima Coil 2mm x 3cm Helical-10 SuperSoft OPTI0203HSS10 00840303701057 F230800706 Optima Coil 2mm x 4cm Complex-10 SuperSoft OPTI0204CSS10 00840303700494 F230800501 Optima Coil 2mm x 4cm Helical-10 SuperSoft OPTI0204HSS10 00840303701064 F230800541 Optima Coil 2mm x 4cm Helical-10 SuperSoft OPTI0204HSS10 00818053026683 F230800814 Optima Coil 2mm x 4cm Helical-10 SuperSoft OPTI0204HSS10 00818053022197 F230900950 Optima Coil 2mm x 6cm Complex-10 Soft OPTI0206CSF10 00818053026027 F230800475 Optima Coil 2mm x 6cm Complex-10 SuperSoft OPTI0206CSS10 00818053025808 F230800696 Optima Coil 2mm x 6cm Complex-10 SuperSoft OPTI0206CSS10 00818053025808 F230800697 Optima Coil 2mm x 6cm Complex-10 SuperSoft OPTI0206CSS10 00818053025808 F230800698 Optima Coil 2mm x 6cm Complex-10 SuperSoft OPTI0206CSS10 00818053025808 F230800699 Optima Coil 2mm x 6cm Complex-10 SuperSoft OPTI0206CSS10 00818053025808 F230800807 Optima Coil 2mm x 6cm Complex-10 SuperSoft OPTI0206CSS10 00818053025808 F230900012 Optima Coil 2mm x 6cm Complex-10 SuperSoft OPTI0206CSS10 00818053021473 F230900951 Optima Coil 2mm x 8cm Complex-10 Soft OPTI0208CSF10 00818053026034 F230800468 Optima Coil 2mm x 8cm Helical-10 SuperSoft OPTI0208HSS10 00840303701088 F230800572 Optima Coil 2mm x 8cm Helical-10 SuperSoft OPTI0208HSS10 00840303701088 F230800733 Optima Coil 2mm x 8cm Complex-10 SuperSoft OPTI0208CSS10 00840303700517 F230800737 Optima Coil 2mm x 8cm Helical-10 SuperSoft OPTI0208HSS10 00818053026706 F230800811 Optima Coil 2mm x 8cm Complex-10 SuperSoft OPTI0208CSS10 00818053025815 F230800903 Optima Coil 3.5mm x 8cm Complex-10 SuperSoft OPTI0358CSS10 00818053025921 F230800484 Optima Coil 3.5mm x 8cm Complex-10 SuperSoft OPTI0358CSS10 00818053025921 F230800531 Optima Coil 3.5mm x 8cm Complex-10 SuperSoft OPTI0358CSS10 00818053025921 F230800798 Optima Coil 3.5mm x 8cm Complex-10 SuperSoft OPTI0358CSS10 00818053025921 F230800965 Optima Coil 3mm x 10cm Helical-10 SuperSoft OPTI0310HSS10 00840303701156 F230800459 Optima Coil 3mm x 10cm Complex-10 SuperSoft OPTI0310CSS10 00818053025907 F230800560 Optima Coil 3mm x 10cm Helical-10 Soft OPTI0310HSF10 00840303700814 F230800564 Optima Coil 3mm x 10cm Complex-10 SuperSoft OPTI0310CSS10 00818053025907 F230800676 Optima Coil 3mm x 10cm Helical-10 Soft OPTI0310HSF10 00840303700814 F230800721 Optima Coil 3mm x 10cm Complex-10 Soft OPTI0310CSF10 00840303700234 F230800738 Optima Coil 3mm x 10cm Complex-10 SuperSoft OPTI0310CSS10 00840303700609 F230800808 Optima Coil 3mm x 10cm Complex-10 Soft OPTI0310CSF10 00818053026072 F230800894 Optima Coil 3mm x 10cm Complex-10 SuperSoft OPTI0310CSS10 00840303700609 F230900039 Optima Coil 3mm x 4cm Helical-10 SuperSoft OPTI0304HSS10 00840303701125 F230800460 Optima Coil 3mm x 4cm Helical-10 Soft OPTI0304HSF10 00840303700784 F230800499 Optima Coil 3mm x 4cm Complex-10 SuperSoft OPTI0304CSS10 00818053025877 F230800675 Optima Coil 3mm x 6cm Helical-10 SuperSoft OPTI0306HSS10 00840303701132 F230800571 Optima Coil 3mm x 6cm Helical-10 SuperSoft OPTI0306HSS10 00840303701132 F230800734 Optima Coil 3mm x 8cm Helical-10 SuperSoft OPTI0308HSS10 00840303701149 F230800461 Optima Coil 3mm x 8cm Complex-10 Soft OPTI0308CSF10 00818053026065 F230800473 Optima Coil 3mm x 8cm Helical-10 SuperSoft OPTI0308HSS10 00818053026768 F230800712 Optima Coil 3mm x 8cm Complex-10 Soft OPTI0308CSF10 00840303700227 F230800842 Optima Coil 3mm x 8cm Complex-10 SuperSoft OPTI0308CSS10 00840303700593 F230800850 Optima Coil 3mm x 8cm Complex-10 Soft OPTI0308CSF10 00840303700227 F230800959 Optima Coil 3mm x 8cm Complex-10 SuperSoft OPTI0308CSS10 00840303700593 F230900014 Optima Coil 4mm x 10cm Complex-10 SuperSoft OPTI0410CSS10 00840303700654 F230800563 Optima Coil 4mm x 10cm Complex-10 SuperSoft OPTI0410CSS10 00840303700654 F230800667 Optima Coil 4mm x 10cm Complex-10 SuperSoft OPTI0410CSS10 00840303700654 F230800683 Optima Coil 4mm x 10cm Complex-10 SuperSoft OPTI0410CSS10 00840303700654 F230800684 Optima Coil 4mm x 10cm Helical-10 Soft OPTI0410HSF10 00840303700852 F230800785 Optima Coil 4mm x 10cm Complex-10 SuperSoft OPTI0410CSS10 00818053025952 F230800849 Optima Coil 4mm x 10cm Complex-10 SuperSoft OPTI0410CSS10 00818053025952 F230800939 Optima Coil 4mm x 10cm Complex-10 SuperSoft OPTI0410CSS10 00818053025952 F230800968 Optima Coil 4mm x 10cm Complex-10 SuperSoft OPTI0410CSS10 00818053021602 F230900384 Optima Coil 4mm x 10cm Complex-10 SuperSoft OPTI0410CSS10 00818053021602 F230900980 Optima Coil 4mm x 13cm Complex-10 Soft OPTI0413CSF10 00818053026119 F230800465 Optima Coil 4mm x 13cm Complex-10 Soft OPTI0413CSF10 00840303700272 F230800552 Optima Coil 4mm x 13cm Complex-10 Soft OPTI0413CSF10 00840303700272 F230800553 Optima Coil 4mm x 13cm Complex-10 Soft OPTI0413CSF10 00840303700272 F230800673 Optima Coil 4mm x 13cm Complex-10 Soft OPTI0413CSF10 00840303700272 F230800680 Optima Coil 4mm x 6cm Helical-10 SuperSoft OPTI0406HSS10 00840303701163 F230800800 Optima Coil 4mm x 6cm Helical-10 SuperSoft OPTI0406HSS10 00840303701163 F230800962 Optima Coil 4mm x 8cm Helical-10 SuperSoft OPTI0408HSS10 00818053026799 F230800820 Optima Coil 4mm x 8cm Helical-10 SuperSoft OPTI0408HSS10 00818053022302 F230900975 Optima Coil 4mm x13cm Complex- 10 Standard OPTI0413CST10 00840303700036 F230800724 Optima Coil 5mm x 10cm Helical-10 SuperSoft OPTI0510HSS10 00840303701217 F230800443 Optima Coil 5mm x 10cm Complex-10 SuperSoft OPTI0510CSS10 00840303700685 F230800783 Optima Coil 5mm x 10cm Helical-10 Soft OPTI0510HSF10 00840303700890 F230800964 Optima Coil 5mm x 13cm Complex-10 SuperSoft OPTI0513CSS10 00840303700692 F230800539 Optima Coil 5mm x 13cm Complex-10 SuperSoft OPTI0513CSS10 00818053025990 F230800902 Optima Coil 5mm x 17cm Complex-10 Soft OPTI0517CSF10 00818053026157 F230800476 Optima Coil 5mm x 17cm Complex- 10 Standard OPTI0517CST10 00840303700050 F230800758 Optima Coil 5mm x 8cm Complex-10 SuperSoft OPTI0508CSS10 00840303700678 F230800851 Optima Coil 5mm x 8cm Complex-10 SuperSoft OPTI0508CSS10 00840303700678 F230900034 Optima Coil 5mm x 9cm Complex-10 Soft OPTI0509CSF10 00818053026140 F230800547 Optima Coil 5mm x 9cm Complex-10 Soft OPTI0509CSF10 00840303700302 F230800705 Optima Coil 6mm x 10cm Helical-10 Soft OPTI0610HSF10 00840303700937 F230800500 Optima Coil 6mm x 11cm Complex-10 Soft OPTI0611CSF10 00818053026171 F230800469 Optima Coil 6mm x 11cm Complex-10 Soft OPTI0611CSF10 00818053021763 F230901000 Optima Coil 6mm x 20cm Complex-10 Soft OPTI0620CSF10 00840303700357 F230800470 Optima Coil 6mm x 20cm Complex-10 Soft OPTI0620CSF10 00840303700357 F230800548 Optima Coil 6mm x 20cm Helical-10 Standard OPTI0620HST10 00840303700715 F230800773 Optima Coil 7mm x 13cm Complex- 10 Standard OPTI0713CST10 00840303700081 F230800545 Optima Coil 7mm x 13cm Complex-10 Soft OPTI0713CSF10 00840303700364 F230800710 Optima Coil 7mm x 24cm Complex-10 Soft OPTI0724CSF10 00818053026218 F230800474 Optima Coil 7mm x 24cm Complex-10 Soft OPTI0724CSF10 00840303700371 F230800691 Optima Coil 7mm x 24cm Complex- 10 Standard OPTI0724CST10 00840303700098 F230800701 Optima Coil 7mm x 24cm Complex-18 OPTI0724COM18 00818053026430 F230800781 Optima Coil 7mm x 24cm Complex-18 OPTI0724COM18 00818053021947 F230901007 Optima Coil 8mm x 27cm Complex-10 Soft OPTI0827CSF10 00818053026232 F230800477 Optima Coil 8mm x 27cm Complex- 10 Standard OPTI0827CST10 00840303700111 F230800702 Optima Coil 8mm x 27cm Complex-10 Soft OPTI0827CSF10 00810068564105 F230900375 Optima Coil 9mm x 23cm Complex-10 Standard OPTI0923CST10 00818053026379 F230800464 Optima Coil 9mm x 23cm Complex-10 Standard OPTI0923CST10 00818053021893 F230900408 Optima Coil 9mm x 30cm Complex-18 OPTI0930COM18 00818053026454 F230800799 Optima Coil 9mm x 30cm Complex-18 OPTI0930COM18 00818053026454 F230800958 Optima Coil 9mm x 30cm Complex-18 OPTI0930COM18 00818053021961 F230900984 Optimax Coil 1.5mm x 3cm Helical OptiMAX Super Soft OPTI0153HSSMX 00818053025419 F230800666 Optimax Coil 10mm x 40cm Complex OptiMAX Soft OPTI1040CSFMX 00818053025280 F230800843 Optimax Coil 10mm x 40cm Complex OptiMAX Soft OPTI1040CSFMX 00818053025280 F230800966 Optimax Coil 12mm x 45cm Complex OptiMAX Soft OPTI1245CSFMX 00818053025303 F230800669 Optimax Coil 14mm x 45cm Complex OptiMAX Soft OPTI1445CSFMX 00818053025327 F230800695 Optimax Coil 16mm x 50cm Complex OptiMAX Soft OPTI1650CSFMX 00818053025341 F230800847 Optimax Coil 16mm x 50cm Complex OptiMAX Soft OPTI1650CSFMX 00818053025341 F230800935 Optimax Coil 1mm x 3cm Complex OptiMAX Super Soft OPTI0103CSSMX 00840303701408 F230800502 Optimax Coil 2.5mm x 2.5cm Complex OptiMAX Super Soft OPTI2525CSSMX 00840303701477 F230800446 Optimax Coil 2.5mm x 2.5cm Complex OptiMAX Super Soft OPTI2525CSSMX 00840303701477 F230800520 Optimax Coil 2.5mm x 5cm Complex OptiMAX Super Soft OPTI0255CSSMX 00818053025020 F230800495 Optimax Coil 2mm x 2cm Complex OptiMAX Super Soft OPTI0202CSSMX 00818053024979 F230800898 Optimax Coil 2mm x 2cm Complex OptiMAX Super Soft OPTI0202CSSMX 00818053024979 F230800900 Optimax Coil 3.5mm x 3.5cm Complex OptiMAX Super Soft OPTI3535CSSMX 00818053025068 F230800739 Optimax Coil 3mm x 10cm Complex OptiMAX Super Soft OPTI0310CSSMX 00818053025051 F230800896 Optimax Coil 3mm x 7cm Complex OptiMAX Super Soft OPTI0307CSSMX 00818053025044 F230800427 Optimax Coil 4.5mm x 10cm Complex OptiMAX Soft OPTI4510CSFMX 00818053025143 F230800826 Optimax Coil 4.5mm x 4.5cm Complex OptiMAX Soft OPTI4545CSFMX 00818053025136 F230800881 Optimax Coil 4.5mm x 4.5cm Complex OptiMAX Soft OPTI4545CSFMX 00818053025136 F230800937 Optimax Coil 4mm x 13cm Complex OptiMAX Soft OPTI0413CSFMX 00818053025129 F230800897 Optimax Coil 4mm x 4cm Complex OptiMAX Soft OPTI0404CSFMX 00818053025099 F230800767 Optimax Coil 4mm x 7cm Complex OptiMAX Soft OPTI0407CSFMX 00818053025105 F230800494 Optimax Coil 5mm x 10cm Complex OptiMAX Soft OPTI0510CSFMX 00818053025167 F230800901 Optimax Coil 5mm x 7cm Complex OptiMAX Soft OPTI0507CSFMX 00818053025150 F230800904 Optimax Coil 7mm x 15cm Complex OptiMAX Soft OPTI0715CSFMX 00818053025228 F230800566 Optimax Coil 7mm x 15cm Complex OptiMAX Soft OPTI0715CSFMX 00818053025228 F230800841 Optimax Coil 7mm x 15cm Complex OptiMAX Soft OPTI0715CSFMX 00818053025228 F230800957 Optimax Coil 7mm x 20cm Complex OptiMAX Soft OPTI0720CSFMX 00818053025235 F230800834 Optimax Coil 7mm x 20cm Complex OptiMAX Soft OPTI0720CSFMX 00818053025235 F230800836 Optimax Coil 7mm x 20cm Complex OptiMAX Soft OPTI0720CSFMX 00818053025235 F230800882 Optimax Coil 9mm x 30cm Complex OptiMAX Soft OPTI0930CSFMX 00818053025266 F230800840
Recalling Firm/
Manufacturer		 BALT USA, LLC
29 Parker Ste 100
Irvine CA 92618-1667
For Additional Information ContactMr. David Vu
949-788-1443
Manufacturer Reason
for Recall		Due to radiopaque (RO) marker was not visible during angiography and it was determined that the RO marker was not manufactured to specification.
FDA Determined
Cause 2		Vendor change control
ActionOn 05/08/2025, the firm sent via priority mail and an, "URGENT: MEDICAL DEVICE RECALL" Letter informing customers that defect impacting specific lots of the Optima and Prestige Coil Systems, in which the distal 3 cm radiopaque (RO) marker may not be visible under fluoroscopy. Customers are instructed to: As a voluntary alternative to returning the affected products, devices from the affected lots can be inspected by trained hospital personnel for the presence of the RO marker using available fluoroscopy imaging equipment prior to a clinical procedure. It is important to conduct this inspection as soon as possible. The image is achieved by taking the fluoroscopic image of the coil system within the unopened box. 1) If the image contains the RO marker, as exemplified from Figure 1, i. Complete the Notice of Receipt (refer to the annex on page 5) indicating the verified results. ii. Mark the inspected boxes with the date and time of the fluoroscopy test and the name of the person performing the test. iii. Return the product back to your inventory with no further action required. iv. Send the completed Notice of Receipt to Balt USA at QA@baltgroup.com. 2) If the image does not contain the RO marker from Figure 2 or if the RO marker is not visually discernable, contact Balt USA at QA@baltgroup.com to process the return of the product. If customers desire to return the products: Distribution agents or Hospital Staff: -Identify and locate the affected Coil System and cease all use of the affected product(s). -For returning collect and put in quarantine and then return them to Balt USA through the usual RMA procedure by contacting our Customer Service. -Contact Balt USA at QA@baltgroup.com or phone +949-788-1443.
Quantity in Commerce2889 devices
DistributionWorldwide - U.S. Nationwide distribution including in the states of AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IL, IN, KS, KY, MA, ME, MN, MO, MS, NC, ND, NE, NJ, NM, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, VT, WA and WI. The countries of Argentina, Armenia, Australia, Belgium, Brazil, Bulgaria, Canada, Chile, Colombia, Croatia, Czechia, Denmark, Dominican Republic, Ecuador, Estonia, Finland, France, Germany, Greece, India, Indonesia, Iraq, Italy, Japan, Jordan, Kazakhstan, Korea, Kyrgyzstan, Lebanon, Lithuania, Malaysia, Mexico, Morocco, Netherlands, Norway, Peru, Poland, Portugal, Romania, Serbia, Slovenia, South Africa, Spain, Sweden, Switzerland, Tunisia, Turkey, Uruguay, and Vietnam.
Total Product Life CycleTPLC 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) Database510(K)s with Product Code = HCG
510(K)s with Product Code = HCG
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