Boston Scientific Corporation 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 M001 Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
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 M001
Brand
Boston Scientific Corporation
Lot Codes / Batch Numbers
Not specified in FDA notice. Check official source for details.
Products Sold
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.
Boston Scientific Corporation is recalling Imager" II Angiographic Catheters, Sterilized with ethylene oxide gas, Manufactured for Boston Scien due to 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. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026