Boston Scientific, Impulse Angiographic Catheter, Sterile EO. Catheters are single lumen catheters with a single proxima

FDA device recall Z-0935-2008 · posted 2008-01-31 · Terminated

Recall details

Recalling firm

Boston Scientific

Reason for recall

Flash may be protruding from the lumen of the catheter shaft. If this flash is present in the catheter, there is the potential of an embolization resulting from the flash detaching from the device during the procedure.

Action taken

The firm sent an Urgent Medical Device Recall letter dated 11/20/2007, to all affected hospitals. The letter describes the defect with the catheters and Product Table information including UPNs, Catalog Numbers, Lot/Batch Numbers and Product Descriptions. The firm requests that further distribution or use of any remaining product affected by the recall should cease immediately. ****IMPORTANT INFORMATION: If it is a practice of the hospital to remove product from the outer carton and store on shelves in the inner-pouch only. Users are to review the Product Table carefully and consider both the inner and outer packaging product codes when search for affected/recalled product.****

Root cause

Release of Material/Component prior to receiving test results

Status

Terminated

Product code

DQO

Quantity affected

211 single units

Distribution

Nationwide Distribution including states of AL, CA, FL, GA, KS, KY, LA, MN, NV, OH, OK, PA, SD, TN, TX, and WI.

Date initiated

2007-11-20

Date posted

2008-01-31

Date terminated

2008-10-23

Location

Maple Grove, MN

Related 510(k) clearances