Prowler Select (10, 14, and Plus) Infusion Catheters with and Without Pre-Shaped Tips

• 2 recalls, same reason

  • Terminated Z-1482-06 FDA Unclassified (pre-2012) ·initiated 11 Aug 2006
  • Terminated Z-1483-06 FDA Unclassified (pre-2012) ·initiated 11 Aug 2006

  Sterility (package integrity) compromised-Cordis Neurovascular, Inc. discovered, during internal testing, that some catheters within the affected lots of CNV preshaped PROWLER and pre-shaped PROWLER SELECT Infusion Catheters may have a pinhole or tear in the Mylar pouch, which may result in a compromise of the sterility inside the pouch.

510(k) Number

K021591 ↗

FDA Product Code

KRA

Device Class

Class II

Regulation

21 CFR Part 870.1210

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

• Prowler Select 10 and 14 Infusion Catheters with and Without Pre-Shaped Tips

  Class II

  FDA 510(k) K020680 Active Cleared 27 Mar 2002

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  Class II

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• Envoy Guiding Catheter

  Class II

  FDA 510(k) K965247 Active Cleared 23 Jul 1997

See all devices from Cordis Neurovascular, Inc. →