Boston Scientific Changes Name of Liberte Bare Metal Stent Due to Safety
November 3, 2009 – The FDA said Boston Scientific recently changed the name of the company's Liberté Bare-Metal coronary stent to VeriFLEX, after reports that Liberté Bare-Metal stents were inadvertently implanted instead of TAXUS Liberté Drug-Eluting stents, and vice versa.
To avoid these mix-ups, Boston Scientific began notifying its customers in September that the Liberté Bare-Metal stent is being renamed the VeriFLEX. The TAXUS Liberté Drug-Eluting stents will keep the same name. The company is re-labeling the outer boxes of all Liberté Bare-Metal stents currently in facilities' inventories.
However, the pouch label, patient guide and directions for use card for these products are not being relabeled at this time and will still bear the Liberté name. Boston Scientific is offering to provide hospitals and cath labs with additional information and training.
The company can be contacted at (877) TAXUS-411.
The company said as of Aug. 31 it was not aware of any major adverse events due to the similar names.
For more information: www.accessdata.fda.gov
More like this
- Drug-Eluting, Bare-Metal Stents Yield Similar Mortality Rates
- Taxus DES II Shows No Additional Very Late Stent Thrombosis
- Boston Scientific Announces FDA Clearance of Two Stent Systems
- Boston Scientific Acquires Biodegradable Stent Polymer Technology
- Boston Scientific Completes Clinical Trial Enrollment for Third-Generation Drug-Eluting Stent