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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 Device 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
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 MN 55311-1565
For Additional Information Contact
763-494-1700
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
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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