Firm-Wide blog

FDA Recalls the LifeStent Solo Vascular Stent Due to Possible Serious Adverse Health Consequences and Death

By Burg Simpson
October 22, 2013
2 min read

Recently, Bard Peripheral Vascular, Inc. issued a recall of all LifeStent Solo Vascular Stents manufactured and distributed between November 2011 and June 13, 2012.  The LifeStent Solo Vascular Stent is a self-expanding stent and delivery system used to improve the inner open space of blood vessels in the treatment of lesions  caused by the abnormal narrowing of blood vessels.

On September 30, 2013, the FDA issued a Class I recall, which is the most serious type of recall.  A Class I recall involves situations where there is a reasonable probability that product use will cause serious adverse health consequences or death.  The LifeStent Solo Vascular Stent was recalled due to  failure to deploy,  partial deployment, and  difficult  deployment.  [FDA Recall]  Possible consequences include:

  • Bleeding
  • Complications from bleeding
  • Loss of limbs
  • Heart attack
  • Stroke
  • Vascular surgery
  • Death

Bard Peripheral Vascular, Inc. sent affected customers a letter on September 13, notifying them of the problem.  The FDA also lists the product codes and lot numbers of the affected products online.  [Recalled Product Lots and Codes]

If you or a loved one suffered injuries that you believe were caused by the LifeStent Solo Vascular Stent, contact one of the experienced attorneys at Burg Simpson today.  The toll-free phone number is 1-800-713-9340.  Our award-winning lawyers would be happy to review your records to determine whether you have a potential viable case.

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