Cardiovascular Systems Recall
Cardiovascular Systems, Inc., ViperSheath Sheath Introducer
Recall Class: Class I
Date Recall Initiated: October 21, 2009
Product:ViperSheath Sheath Introducer is manufactured by Thomas Medical Products, Inc. and is distributed by Cardiovascular Systems, Inc. (CSI).
| Lot Ranges | Catalog Numbers |
|---|---|
| S28117 through S29174 | 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 |
These devices were manufactured from March 1, 2009 through September 16, 2009 and distributed from March 19, 2009 though September 17, 2009.
Use:
The device is a long-coiled, reinforced, kink-resistant catheter-like tube (sheath) that helps a physician insert a catheter into a blood vessel.
Recalling Firm:
Thomas Medical Products, Inc.
65 Great Valley Parkway
Malvern, Pennsylvania 19355
Distributor:
Cardiovascular Systems, Inc.
651 Campus Drive
St. Paul, Minnesota 55112
Reason for Recall:
Fractures may occur during use. If this occurs, patients may need unplanned surgery to remove the fragments or to control bleeding.
FDA Comments: On October 22, 2009, Thomas Medical sent a letter to CSI to inform them of the need to recall the product. On November 13, 2009, CSI issued a press release for the recall of the ViperSheath. Both companies are arranging for the return of all products.
Class 1 recalls are the most serious type of recall and involve situations in which there is a reasonable probability that use of these products will cause adverse health consequences or death.