Edwards Lifesciences LifeStent FlexStar Bilary Stent System Application, Model EX080801CD; 8 MM x 80 MM stent, 80 CM Del

FDA device recall Z-0179-2008 · posted 2007-11-28 · Terminated

Recall details

Recalling firm

Edwards Lifesciences, Llc

Reason for recall

Failure to deploy.

Action taken

This recall was executed by an Urgent-Product Recall letter dated March 15, 2007, which was delivered via overnight service to the affected accounts on 3/19/07. In addition, the affected sales force was notified by Email and given a copy of the recall letter. The sales force was asked to assist in retrieval of the product. The letter advises that one lot of the Edwards LifeStent FlexStar Bilary Stent System -- Model EX080801CD; 8 MM x 80 MM stent, 80 CM delivery system, Lot FR6K0319 may exhibit incidences of failure to deploy and is being recalled. Customers are advised to check their inventory for lot #FR6K0319 and remove all unused product from stock. Product is to be returned or it will be retrieved. The letter also advises that if the product has been implanted, there is no need to inform the patient of this notification as this is solely related to the delivery system and the characteristics of the stent are not affected in any way. Either the customer or the sales representatives will return written notification of the status of product from this lot which had been shipped.

Root cause

Process control

Status

Terminated

Product code

FGE

Quantity affected

12 units

Distribution

Nationwide including states of OK, GA, CA WI, MO, and LA

Date initiated

2007-03-19

Date posted

2007-11-28

Date terminated

2012-03-26

Location

Irvine, CA

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