RX ACCULINK Carotid Stent System, 10x40 mm, Product Number: 1011344-40, Lot Number: 9081851. Indicated for the treatment

FDA device recall Z-0749-2010 · posted 2010-01-29 · Terminated

Recall details

Recalling firm

Abbott Vascular-Cardiac Therapies dba Guidant Corporation

Reason for recall

The recall was initiated after Abbott Vascular discovered, through internal testing, that the affected lot may not meet our quality specifications for catheter shaft tensile strength.

Action taken

Abbott Vascular's Sales Representatives initiated customer contact with the identified consignees beginning October 1, 2009 . They provided the consignees with a recall letter with attached fax-back effectiveness check form. The recall letter instructed the consignees to work with their local account representative to review their inventory, complete the attached recall effectiveness check form and return identified products to Abbott Vascular. For further information, contact Abbott Vascular Customer Service at 1-800-227-9902.

Root cause

Process control

Status

Terminated

Product code

NIM

Quantity affected

22 units

Distribution

Nationwide Distribution.

Date initiated

2009-10-01

Date posted

2010-01-29

Date terminated

2011-09-27

Location

Temecula, CA