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Terminated

Boston Scientific Liberte Monorail and Over-the-Wire Coronary Stent Systems to be relabeled as VeriFLEX". The Liberte Coronary Stent System consists of a balloon expandable stainless steel stent, pre-mounted on either a Liberte Monorail (MR) or Liberte Over-the-Wire (OTW) delivery system. The Liberte system comes in stent diameters of 2.25, 2.50, 2.75, 3.00, 3.50, 4.00, 4.50 and 5.00 mm and stent lengths of 8, 12, 16, 20, 24, 28 and 32 mm. The stent is mounted on the balloon between two radiopaque markers which, in conjunction with fluoroscopy, aid in the placement of the systems balloon segment and stent. The balloon enables high pressure inflations and can be used for post-stent dilatation.

FDA Recall Z-0068-2010 · Posted 2009-10-21

Recalling FirmBoston Scientific Corporation
Recall StatusTerminated
Product CodeMAF
Date Initiated2009-09-11
Date Terminated2012-06-28
Product Quantity391,769

Reason for Recall

Boston Scientific initiated a field correction for the Liberte Bare-Metal coronary stent products. They have received reports from cardiac cath labs that TAXUS Liberte Paclitaxel-Eluting (TAXUS Libert Drug-Eluting) coronary stents have been inadvertently selected when the interventional cardiologist intended to implant a Liberte Bare-Metal stent, and Libert Bare-Metal stents have been ina

Firm Action

Boston Scientific issued an "Urgent Medical Device Field Correction" letter dated September 18, 2009. The letter was addressed to Risk Manger/Field Action Contact. The letter described the product, problem and actions which included renaming the Liberte Bare-Metal stent as VeriFlex" Bare-Metal stent. Enclosed with the letter included the Direction for Field Correction and a Reply Verification Tracking Form. For further information, contact you local Boston Scientific Sales Representative or call 1-800-811-3211.

Root Cause

Labeling design

Distribution Pattern

Nationwide Distribution -- United States including Puerto Rico.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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