Boston Scientific Guider Softip TM XF Guide Catheter Catheter is intended to facilitate the placement of interventional

FDA device recall Z-0885-2011 · posted 2011-01-07 · Terminated

Recall details

Recalling firm

Boston Scientific Corporation

Reason for recall

Complaint about product quality: degradation of polymer portion of the distal section of the catheter.

Action taken

Boston Scientific sent an Urgent Medical Device Recall and Correction letter dated December 18, 2009, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to check their inventory for the affected product and fill out the Customer Instructions and REPLY VERIFICATION TRACKING FORM indicating the status of the affected product and send a copy of the form by fax to 510-624-1600 or e-mail to Joe.Nesci@beci.com.

Root cause

Other

Status

Terminated

Product code

DQY

Quantity affected

94,296 units

Distribution

Worldwide. US Domestic including US Federal Government, and foreign countries.

Date initiated

2009-12-18

Date posted

2011-01-07

Date terminated

2011-12-19

Location

Fremont, CA