Posts Tagged ‘ViperSheath’

Cardiovascular Systems, Inc. (CSI) has recalled all lots of the ViperSheath^TM due to reports about stretching or fracture of the sheath during heart catheterizations. In the event of a device fracture, broken segments of the device may require immediate surgery to be removed and/or to control bleeding. A failure also has the potential to perforate or dissect a vessel. The ViperSheath^TM is a developed and manufactured by Thomas Medical Products, Inc., and distributed by CSI.

The people who need this kind of surgery are obviously, not in the best of health. The procedure itself has risks. How does it happen that a device that is going to be used in delicate, dangerous surgery is not tested enough to identify such a defect? There is money to be made in doing heart catheterizations, and in providing devices like the ViperSheath that may make the procedure better. That’s fine with me and with most everyone I would guess, but putting something on the market that can break off inside one of your arteries and perforate the artery is not what anyone would call responsible design or manufacturing. Crazy stuff. We all deserve better.

To any of the patients who have had a problem as a result of this device, our sympathy. We hope the consequences to you are minimal. CSI says it has notified all customers by FedEx about the recall and says it is arranging for the return of all products…and if they don’t get them all? What happens then? What happens to those who had a perforation of an artery but were lucky enough to survive? They’re not talking about that. People in Tennessee or anywhere else who have had ViperSheath used in a procedure should talk to their doctor to determine if there was any problem with their procedure that was related. However, make sure the doctor knows you are not blaming him or her – this is a problem with the device that doctors didn’t know about.

The recall encompasses products distributed from March 25, 2009 to October 21, 2009

To read the entire recall, click here.