FDA Device Recall Z-0035-2009: Bard Peripheral Vascular Inc

Recall Parameters & Description

Normalized public record details for FDA recall code Z-0035-2009.

Recall Res Number

Z-0035-2009

Recalling Firm / Manufacturer

Bard Peripheral Vascular Inc

FEI Number

2020394

Recall Status

Terminated

Recall Classification

N/A

Date Initiated

2008-08-29

Date Posted

2008-10-10

Date Terminated

2012-04-06

Product Code

FGE

Event Number

49405

Product Quantity

45 units

Product Description Edwards Lifesciences LifeStent FlexStar Self-Expanding Biliary Stent System, Edwards Lifesciences LLC Irvine, CA 92614, Model EX060201CD. The LifeStent FlexStar self-expanding biliary stent system is intended for use in the palliation of malignant strictures (neoplasms) in the biliary tree.

Reason for Recall Some LifeStent FlexStar Systems may exhibit a gap between the tip of the delivery system and the primary sheath such that the guidewire lumen is visible.

Action Details The customer letters for the tip to sheath gap were sent on 8/29/2008 with return receipt. The letter advises that C.R. Bard has determined that some LifeStent FlexStar Systems may exhibit a gap between the tip of the delivery system and the primary sheath such that the guidewire lumen is visible. Per the letter, the firm's analysis has determined that a gap between the tip of the delivery system and the delivery system sheath may be associated with difficult advancement to the treatment site. Users are instructed to inspect all devices to verify that there is not a gap between the tip and sheath (orange colored guidewire lumen is visible), prior to use and to not use any devices that exhibit a tip to sheath gap condition. If devices that exhibit a tip to sheath gap are identified, customers are advised to call Customer Service at 1-800-321-4254 to return the device and a replacement will be provided at no cost. The letter also advises that the Instructions for Use for the LifeStent FlexStar System will be updated to include the inspection step which is provided in the letter.

Distribution Pattern Nationwide

Code Information / Serial Numbers Lot Numbers: FR6J0255, FR6K0341, and R58284565

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Medical Device Recall: Z-0035-2009

Recall Parameters & Description

Related Establishments / Registrations

Public Record Disclaimer