Cardiovascular Systems Initiates Recall of Defective Catheter Introducer
On November 16, 2009, Cardiovascular Systems announced a recall of all lots of its ViperSheath catheter sheath introducer based on reports of stretching or fracturing of the product. The ViperSheath is a coil-reinforced catheter introducer of percutaneous entry of intravascular devices. If a fracture occurs, there is a potential for a segment to break off and travel through the blood stream, requiring surgery to remove. Since the catheter is reinforced by an interior coil, damage may occur if the end of the coil snags on the blood vessel.
The recall pertains to ViperSheath products distributed from March 25, 2009 to October 21, 2009. The following lot and catalog numbers included in the recall are:
- Lot range: S28117 through S29174
- Catalog numbers: VPR-ISH 5 X 85, VPR-ISH 6 X 85, VPR-ISH 7 X 85, VPR-ISH 5 X 45, VPR-ISH 6 X 45, VPR-ISH 7 X 45
Three instances of the failure of this medical device were recorded and all patients affected underwent successful surgery to remove the segment. Once a catheter is successfully in place, not further action is required as the conditions that cause breakage will no longer occur.
To report any adverse events with this product, contact the FDA’s MedWatch program at www.fda.gov/medwatch.
If you or a loved one has suffered any medical problems as a result of a failed ViperSheath introducer, please contact the skilled product liability attorneys at Schlichter, Bogard & Denton, LLP to learn more about your legal options.