Boston Scientific, IMAGER II Angiographic Catheter, Sterilized with ethylene oxide gas. Made in Ireland, Manufactured fo

FDA device recall Z-1394-2012 · posted 2012-04-11 · Terminated

Recall details

Recalling firm

Boston Scientific Corporation

Reason for recall

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

Action taken

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 Angiographic customers: Eight total number of customers not notified initially (3 USA and 5 APA customers were sent the same initial letter with a a revised send date of April 18, 2012, 329 total number of US Customers notified initially with an incomplete product list were sent a revised notification letter. Urology: Imager II Torque customers: 1 US Customer was not notified initially. This customer was sent the same initial letter with a revised send date of April 18, 2012. Fifteen US Customers notified with incomplete product list. These customers were sent a revised notification letter.

Root cause

Package design/selection

Status

Terminated

Product code

DQO

Quantity affected

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, Ch

Date initiated

2012-03-15

Date posted

2012-04-11

Date terminated

2014-04-14

Location

Maple Grove, MN

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