Recall Z-1394-2012 ยท DQO Catheter, Intravascular, Diagnostic
Boston Scientific Corporation
Boston Scientific, IMAGER II Angiographic Catheter, Sterilized with ethylene oxide gas. Made in Ireland, Manufactured for Boston Scientific Corporation, One Boston Scientific Place, Natick, MA 01760-1537. The following product is being recalled: "Material Number/(OUTER CARTON LABEL OF 5pk)"/"Material Number (INNER-POUCH LABEL FOR EACH SINGLE CATHETER)" / Material Description / Catalog Number.
| Date | Apr 11, 2012 (initiated Mar 15, 2012) |
| Status | Terminated |
| Reason | Boston Scientific Corporation is initiating a Medical Device Recall of certain lots/batches of the Imager" II Catheter (Urology) and the Imager" II Angiographic Catheter . An investigation has found that, during shipping, some units in the 5-pack box may experience a physical interaction between the carton and the area on the pouch where the hub is located. This interaction was found to cause pi |
| Root cause | Package design/selection |
| Action | Boston Scientific sent an " Urgent Medical Device Recall" letter dated March 14. 2012. the letter was addressed to "Dear Risk/Materials Manager. The letter described the problem and the product involved in the recall. Advised consignees to cease the distribution of any remaining unused product affected. Advised distributors that the recall notification should be forwarded to their customers. Requested consignees to complete and return the Reply Verification tracking Form enclosed by fax to 508-683-5578. For questions regarding this recall 763-494-1700. Recall Expanded 4/24/12: Imager II A |
| Quantity | 406,450 (416,555 USA, 389,895 OUS) |
| Distribution | Worldwide Distribution - USA (nationwide) and the countries of Arab Emir, Azerbaijan, Austria, Australia, Azerbaijan, Belgium, Bulgaria, Bahrain, Bermuda, Brazil, White Russia, Canada, Switzerland, Chile, China, Colombia, Cyprus, Czech Republic, Germany, Denmark, Ecuador, Estonia, Egypt, Spain, Finl |
| FDA record | Open on fda.gov |