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U.S. Department of Health and Human Services

Class 2 Device Recall IMAGER II ANGIOGRAPHIC CATHETER

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 Class 2 Recall
IMAGER II ANGIOGRAPHIC CATHETER
see related information
Date Posted January 21, 2010
Recall Status1 Terminated on December 12, 2011
Recall Number Z-0336-2010
Recall Event ID 53704
Premarket Notification
510(K) Number
K050863 
Product Classification Catheter, Intravascular, Diagnostic - Product Code DQO
Product Imager" II Angiographic Catheters, Sterilized with ethylene oxide gas, Manufactured for Boston Scientific Corporation, One Boston scientific Place, Natick, MA 01760-1537, USA, Made in Ireland, Unit 7,8 & 9 Annacotty Business Park, Annocotty, Co. Limerick, Ireland: Material Number (OUTER CARTON LABEL OF 5pk) /Material Number (INNER-POUCH LAB LE FOR EACH SINGLE CATHETER)/ Catalog Number /Material Description: M001314001 M001314000 31-400 IMAGER II/5/ST/65/038 BX5; M001314021 M001314020 31-402 IMAGER II/5/ST/65/035 BX 5; M001314071 M001314070 31-407 IMAGER II/5/BERN/40/035 BX 5; M001314081 M001314080 31-408 IMAGER II/5/BERN/40/038 BX5; M001314091 M001314090 31-409 IMAGER II/5/BERN/65/035 BX 5; M001314101 M001314100 31-410 IMAGER II/5/BERN/65/038 BX5; M001314301 M001314300 31-430 IMAGER II/5/SIM1/65/038 BX5; M001314521 M001314520 31-452 IMAGER II/5/CHGB/65/038 BX5; M001314561 M001314560 31-456 IMAGER II/5/CHG2.5/65/038 BX5; M001314571 M001314570 31-457 IMAGER II/5/CHG2.5/65/035 BX 5; M001314581 M001314580 31-458 IMAGER II/5/CONTRA 2/65/038 BX5; M001314591 M001314590 31-459 IMAGER II/5/CONTRA 2/65/035 BX 5; M001314611 M001314610 31-461 IMAGER II/5/DUCK/65/035 BX 5; M001314661 M001314660 31-466 IMAGER II/5/C2/65/038 BX5; M001314671 M001314670 31-467 IMAGER II/5/C2/65/035 BX 5; M001314681 M001314680 31-468 IMAGER II/5/C2+2 SIDE HOLES/65/038 BX5; M001314691 M001314690 31-469 IMAGER II/5/C2+2 SIDE HOLES/65/035 BX 5; M001314751 M001314750 31-475 IMAGER II/5/TRAIN/65/038 BX5; M001314761 M001314760 31-476 IMAGER II/5/MIK/65/038 BX5; M001314791 M001314790 31-479 IMAGER II/5/HK1.0/65/035 BX 5; M001314801 M001314800 31-480 IMAGER II/5/SHK0.8/65/038 BX5; M001314811 M001314810 31-481 IMAGER II/5/SHK0.8/65/035 BX 5; M001314821 M001314820 31-482 IMAGER II/5/SHK1.0/65/038 BX5; M001314851 M001314850 31-485 IMAGER II/5/RC1/65/035 BX 5; M001314861 M001314860 31-486 IMAGER II/5/RC2/65/038 BX5; M001314881 M001314880 31-488 IMAGER II/5/RDC/65/038 BX5; M001314891 M001314890 31-489 IMAGER II/5/RDC/65/035 BX 5 and M001314911 M001314910 31-49I IMAGER II/5/RDC+2 SIDEHOLES/65/035 BX 5: M001315001 M001315000 31-500 IMAGER II/4/TENNIS RACQUET/65/035 BX5; M001315031 M001315030 31-503 IMAGER II/5/TENNIS RACQUET/65/035 BX5; M001315061 M001315060 31-506 IMAGER II/5/TENNIS RACQUET/65/038 BX5; M001315091 M001315090 31-509 IMAGER II/4/PIGTAIL/65/035 BX5; M001315101 M001315100 31-510 IMAGER II/4/STRAIGHT/65/035 BX5; M001315131 M001315130 31-513 IMAGER II/5/PIGTAIL/65/038 BX5; M001315161 M001315160 31-516 IMAGER II/5/STAIGHT/65/038 BX5; M001315191 M001315190 31-519 IMAGER II/5/PIGTAIL/65/035 BX5; M001315201 M001315200 31-520 IMAGER II/5/STRAIGHT/65/035 BX5; M001315251 M001315250 31-525 IMAGER /4/CONTRALATERAL/65/035 BX5; M001315281 M001315280 31-528IMAGER II/5/CONTRALATERAL/65/035 BX5; M001315311 M001315310 31-531 IMAGER II/5/CONTRALATERAL/65/038 BX5; M001316021 M001316020 31-602 MODEL-IMAGER II/ 4/ ST/65/035; M001316071 M001316070 31-607 MODEL-IMAGER II/ 4/ BERN/40/035; M001316091 M001316090 31-609 MODEL-IMAGER II/ 4/ BERN/65/035; M001316311 M001316310 31-631 MODEL-IMAGER II/ 4/ SIM1/65/035; M001316531 M001316530 31-653 MODEL-IMAGER II/ 4/ CHGB/65/035; M001316551 M001316550 31-655 MODEL-IMAGER II/ 4/ CHGC/65/035; M001316581 M001316580 31-658 MODEL-IMAGER II/ 4/ CONTRA 2/65/035; M001316691 M001316690 31-669 MODEL-IMAGER II/4/C2+2 SIDE HOLES/65/035 and M001316851 M001316850 31-685 MODEL-IMAGER II/ 4/ RC1/65/035. Imager " II Angiographic Catheters are sterile, single-use diagnostic intravascular catheters. These catheters are available in a variety of flush and selective shapes with
Code Information Lot/Batch 57139 57392 57709 57248 57533 57258 57263 57612 57242 57243 57510 57530 57531 57173 57296 57297 57381 57534 57535 57238 57389 57697 57383 57130 57265 57245 57214 57266 57298 57784 57120 57617 57621 57128 57708 57244 57783 57382 57119 57695 57698 57133 57696 57580 57247 57135 57123 57782 57134 57268 57388 57369 57124 57600 57419 57278 57283 57699 57233 57414 57415 57225 57528 57409 57410 57282 57587 57403 57404 57583 57044 57045 57046 57090 57275 57581 57582 57588 57279 57586 57706 57375 57215 57602 57603 57608 57578 57579 57376 57526 57527 57577 and 57378.
Recalling Firm/
Manufacturer
Boston Scientific Corporation
1 Scimed Pl
Maple Grove, Minnesota 55311-1565
Manufacturer Reason
for Recall
The sterile barrier in the packaging (pouch) that contains the catheter may be breached. The breach of sterility could lead to a contamination of the device with subsequent transfer of infectious agents to the patient.
FDA Determined
Cause 2
PRODUCTION CONTROLS: Packaging Process Control
Action Two Boston Scientific "Urgent Voluntary Medical Device Recall" letters were sent to consignees on October 29, 2009. The letters described the problem and the affected product. Consignees were instructed to cease use and distribution of the product and to complete and return the Account Reply Verification Tracking Form. The first letter with the heading, "Boston Scientific IMAGER II Angiographic Catheter (Peripheral Intervention)", was addressed to the Risk Manager/Field Action Contact. The second letter with the heading, "Imager II Urology Torque Catheters" was addressed to the Risk/Materials Manager. Direct questions about the recall to your local Sales Representative or Boston Scientific Corporation by calling at 1-763-494-1700.
Quantity in Commerce 8845 boxes (5/box) US ; 3202 boxes (5/box) OUS
Distribution Worldwide Distribution -- United States (AL, AZ, AR, CA, CO,CT, DE, DC, FL, GA, HI, IL IN, IA, KS, KY, LA, ME, MD, MA, MI, MN, MS, MO,MT, NE, NV, NH, NJ, NM, NY, NC, ND, OH, OK, OR, PA, RI, SC, SC, TN, TX, UT, VT, VA, WA, WV and WI), United Arab Emir., Dutch Antilles, Austria, Australia, Belgium, Brazil, Canada, Switzerland, Chile, Colombia, Cyprus, Czech Republic, Germany, Denmark, Egypt, Spain, Finland, France, Great Britain, Greece, Hong Kong, Hungary, Israel, Italy, South Korea, Kuwait, Lebanon, Lithuania, Mexico, Malaysia, Netherlands, Norway, New Zealand, Poland, Puerto Rico, Portugal, Qatar, Russian Fed., Saudi Arabia, Sweden, Singapore, Slovakia, Syria, Thailand, Tunisia, Turkey, Trinidad, Tobago, Taiwan, and South Africa.
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = DQO and Original Applicant = BOSTON SCIENTIFIC CORP.
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