FDA Medical Device Recalls (openFDA)
Cordis Neurovascular, Inc.: Cordis Neurovascular Pre-Shaped PROWLER Infusion Catheters.
- Recall number
- Z-1482-06
- Recalling firm
- Cordis Neurovascular, Inc.
- Product
- Cordis Neurovascular Pre-Shaped PROWLER Infusion Catheters.
- Status
- Terminated
- Initiated
- 2006-08-11
- Posted
- 2006-09-02
- Terminated
- 2008-11-25
- Reason
- 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
- 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
- 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.
- Lot, serial or model codes
- 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.
- 510(k) numbers
- ["K021591"]
- PMA numbers
- not on file
- Product code
- KRA
- Firm FEI
- 1000222137
- Firm city
- Miami Lakes
- Firm state
- FL
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28