Bard LifeStent Recall Issued for Solo Vascular Stent
A Class I medical device recall has been issued for Bard LifeStent Solo Vascular Stents, due to a risk of malfunctions in the expandable stents that could cause loss of limb or even death.
The Bard LifeStents are implantable self-expanding stents and delivery systems used to assist in opening blood vessels for patients with abnormally narrowing blood vessels caused by lesions.
On October 18, the FDA posted information about a Bard LifeStent recall, indicating that the Solo Vascular Stents may not deploy properly and cause serious health problems. Due to the reasonable probability that use of the product may cause injury or death, the FDA has categorized that action as a Class I recall, which is the most dangerous type of recall.
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The recalled stents may fail to deploy, only partially deploy, or have difficulty deploying leading to severe health consequences, such as bleeding complications, loss of limb, heart attack, stroke, immediate vascular surgery, and even death. To date, no injuries or deaths have been reported in relation to the affected stents.
The recall includes LifeStent Solo Vascular Stents with item numbers EX062001CL, EX072001CL, EX062003CL, EX072003CL and were manufactured by Bard Peripheral Vascular Inc. of Tempe, Arizona where they were distributed for sale to licensed physicians and healthcare providers between November 2011 and June 13, 2012. For a full list of recalled product codes consumers may visit https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=122212.
On September 30 Bard Peripheral Vascular Inc. issued an Urgent Medical Device Recall Notification letter to all known customers informing them of the issues and instructions of how to proceed. The letter indicates customers should complete the recall and effectiveness check form and fax the information back to Bard at 1-800-994-6772 and to also contact Bard’s Recall Coordinator at 1-800-321-4254 or email them at email@example.com to receive a Return Authorization number or Consignment Recall Number.
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