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Thomas Medical Safesheath Introducer Recall

On December 17, 2009, the FDA announced a recall of Thomas Medical Products’ Safesheath CSG Sheath Introducer because the soft tip could break during use, leading to:

  • Blood clots
  • Strokes
  • Myocardial infarctions.

The Safesheath Sheath Introducer is used during the insertion of pacing and defibrillator wires and catheters.  During use, the tip of the sheath can break off.  Once separated the tip can move through the blood vessel into the lungs or heart.  The tip may also enter the arteries and potentially cause a blood blockage anywhere in the body, including in the brain.  This can lead to stroke, heart attack and death.  Thomas Medical has received 38 adverse event reports where the Safesheath tip became separated.

If you or a loved one has suffered a blood clot, stroke or heart attack after having pacing or defibrillator wires placed, you may be entitled to compensation.  Our attorneys would be happy to review your records to determine whether the Safesheath CSG Sheath Introducer caused your injury and whether you have a viable case against Thomas Medical Products.

Contact the medical device attorneys at Burg Simpson today if you or your loved one has been the victim of injuries caused by a dangerous or defective medical device. Our attorneys will provide you with a free initial consultation, where we will listen to your problems and help you determine what the best course of action will be.

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Burg Simpson Eldredge Hersh & Jardine, P.C. is a law firm serving the Rocky Mountain Region. The firm has offices in Denver, Colorado, Cody, WY, Cincinnati, Ohio, and Phoenix, AZ. The Firm is responsible for the content on the website, this information is not to be interpreted as providing legal services, nor as proposing any form of legal advice.