Boston Scientific Liberte Monorail and Over-the-Wire Coronary Stent Systems to be relabeled as VeriFLEX". The Liberte Co

FDA device recall Z-0068-2010 · posted 2009-10-21 · Terminated

Recall details

Recalling firm

Boston Scientific Corporation

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

Action taken

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

Status

Terminated

Product code

MAF

Quantity affected

391,769

Distribution

Nationwide Distribution -- United States including Puerto Rico.

Date initiated

2009-09-11

Date posted

2009-10-21

Date terminated

2012-06-28

Location

Maple Grove, MN