Z-1482-06

Cordis Neurovascular Pre-Shaped PROWLER Infusion Catheters

Name: Z-1482-06 Cordis Neurovascular Pre-Shaped PROWLER Infusion Catheters
Creator: Cordis Neurovascular, Inc.
Published: 2006-08-11
License: https://open.fda.gov/license/

Cordis Neurovascular, Inc. / initiated 2006-08-11 / Terminated / root cause: packaging

FDA source

Cordis Neurovascular, Inc. began a recall of Cordis Neurovascular Pre-Shaped PROWLER Infusion Catheters on 2006-08-11. The reason FDA records is "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-1482-06
Status: Terminated
Initiated: 2006-08-11
Posted: 2006-09-02
Terminated: 2008-11-25
Recalling firm: Cordis Neurovascular, Inc.
Product: Cordis Neurovascular Pre-Shaped PROWLER Infusion Catheters.
Product code: KRA Catheter, Continuous Flush
Reason for recall: 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.
Root cause tag: packaging
FDA root cause: Other
Action: All consignees were notified by letter on 8/14/06. All Cordis Neurovascular sales representatives will also participate, to ensure expedited communication.
Quantity in commerce: 15 Lot numbers (46,452)
Distribution: Class II Recall - Worldwide distribution --- including USA and countries of Asia Pacific, Europe, Latin America, Canada, Japan and Australia.
Product codes and lots: All lot numbers equal to or lower than: CAT 606051FX - LOT 13084977; CAT 606051JX - LOT 13077739; CAT 606051MX - LOT 13100828; CAT 606151FX - LOT 13095822; CAT 606151JX - LOT 13090978; CAT 606151MX - LOT 13090976; CAT 6062310F - LOT 13090973; CAT 6062310J - LOT 13090974; CAT 6062310M - LOT 13082015; CAT 6062510FX - LOT 13075472; CAT 6062510JX - LOT 13090975; CAT 6062510MX - LOT 13082020; CAT 6062511FX - LOT 13090979; CAT 6062511JX - LOT 13090971; CAT 6062511MX - LOT 13090972.

Product code KRA

K021591Class IIProwler Select (10, 14, and Plus) Infusion Catheters with and without Pre-Shaped TipsCordis Neurovascular, Inc. / cleared 2002-05-22

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)