Catheter Sheaths Recalled, May Fracture During Use and Injure Patients

All lots of ViperSheath Sheath Introducer products have been recalled because the devices may fracture during use, injuring patients and requiring further surgeries to remove fragments and stop potentially deadly internal bleeding.

The recalled device is a long-coiled, reinforced, kink-resistant catheter-like tube used to help a physician insert a catheter into a blood vessel. If the sheath breaks during use, pieces of the wire coil inside may be exposed, which poses a risk of dissecting or perforating blood vessels.

Also, patients may have to undergo additional surgeries to remove the fragments of the broken sheath, the Food and Drug Administration said.

The FDA has designated the safety action a Class I recall, the most serious type of recall the agency can issue that is reserved for situations in which there is a reasonable probability that use of these products will cause adverse health consequences or death.

Specific Products Recalled

Sheaths introducers distributed from March 25, 2009 to October 21, 2009 and included in the recall, which covers the following lot ranges and catalog numbers:

• 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

The recalled devices were manufactured by Thomas Medical Products, Inc. of Malvern, Penn. and distributed by Cardiovascular Systems, Inc. of St. Paul, Minn. Both companies are arranging for the return of all products, the FDA said.

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