Cardiovascular Systems Inc. Recalls Catheter Sheath After Medical Device Breaks Inside Patient | Shapiro, Washburn & Sharp

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.


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