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Cardiovascular Systems Inc. Recalls Catheter Sheath After Medical Device Breaks Inside Patient

The U.S. Food and Drug Administration, or FDA, has requested Cardiovascular Systems Inc. to recall its ViperSheath catheter introducers made by Thomas Medical Products after receiving reports that the device had fractured inside a patient. This is the second medical recall of a catheter sheath. Johnson & Johnson's (JNJ) Cordis Corp recalled is Crossover sheath introducers, also made by Thomas Medical Products, in October.

Sheath introduces are large, gradually tapered tubes that create an entry point in to arties and veins. The recalled catheter introducers fracture inside the patient’s body. The fractured pieces have the potential to become lodged inside blood vessels, causing distal ischemia or infarctions.

So far three patients have had to undergo surgery to have the broken pieces removed after their ViperSheath device fractured.

Cardiovascular Systems Inc. is asking customers to return the dangerous medical devices and the FDA is watching the recall through their MedWatch program.

If you recently underwent a medical surgery that required the use of a catheter introducer we urge you to contact the hospital that performed your surgery and find out if the ViperSheath or Crossover sheath were used in your surgery.

About the Editors: Shapiro, Cooper Lewis & Appleton is a law firm which focuses on injury and accident law and we have experience handling medical malpractice cases. Check out our case results to see for yourself. Our law firm has offices in Elizabeth City, North Carolina (NC) and Virginia Beach, Virginia (VA). Our attorneys have handled thousands of medical malpractice cases including surgical errors, misdiagnosis, and negligence. We would like to send you one of our FREE reports about medical malpractice, including our Top 10 Tips from a Medical Malpractice Insider and our special report on the top 5 surgical errors you need to know about. Our lawyers hold licenses in NC, VA, SC, WV, KY and DC. We are ready to talk to you by phone right now—we provide free initial confidential injury case consultations, so call us toll free at 1-800-752-0042. Our injury attorneys also host an extensive injury law video library on Youtube .  In addition, our lawyers proudly edit the Northeast North Carolina Injuryboard, as well as the Virginia Beach Injuryboard and Norfolk Injuryboard as a pro bono public information service.

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Labels: attorney Cardiovascular Systems Inc. Johnson & Johnson catheter Crossover device FDA Food and Drug Administration injury introducer Jim Lewis medical recall sheath Thomas Medical Products ViperSheath