Imager" II Angiographic Catheters, Sterilized with ethylene oxide gas, Manufactured for Boston Scientific Corporation, O

FDA device recall Z-0336-2010 · posted 2010-01-21 · Terminated

Recall details

Recalling firm

Boston Scientific Corporation

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.

Action taken

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.

Root cause

Packaging process control

Status

Terminated

Product code

DQO

Quantity affected

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

Date initiated

2009-10-22

Date posted

2010-01-21

Date terminated

2011-12-12

Location

Maple Grove, MN

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