RX ACCULINK Carotid Stent System 10 X 20mm, Part Number: 1011342-20, Lot Number: 0072061 The RX Acculink Carotid Stent S

FDA device recall Z-0338-2011 · posted 2010-11-10 · Terminated

Recall details

Recalling firm

Abbott Vascular

Reason for recall

The recall was initiated because Abbott vascular has discovered through internal testing that the affected lots may not meet the firm's quality specifications for catheter shaft tensile strength. If the affected device is used it may result in acute stent deployment difficulties and subsequent intervention.

Action taken

Abbott Vascular sent an URGENT DEVICE RECALL letter dated September 10, 2010, to all consignees. The letter identified the product, the problem, and the action to be taken. The Sales Representatives were to personally visit each account to deliver the recall letter and assist in identifying and returning any unused devices to Abbott Vascular. Also, Abbott Vascular Regulatory Compliance initiated contact with the Risk Management department at each account by phone to verify their mailing address and provide a courtesy copy of the recall letter. The consignees were instructed to work with their local account representative to review their inventory, complete the Recall Effectiveness Check and return identified products to Abbott Vascular. For questions regarding this recall call (951) 914-3324.

Root cause

Pending

Status

Terminated

Product code

NIM

Quantity affected

42 units total for all products

Distribution

Nationwide Distribution including AL, CA, CT, DC, FL, GA, IA, IL, IN, MA, ME, MI, MN, MO, OH, OK PA, TX, VA, and WI

Date initiated

2010-09-10

Date posted

2010-11-10

Date terminated

2010-11-16

Location

Temecula, CA