FDA Medical Device Recalls (openFDA)
Cordis Neurovascular, Inc.: Cordis Neurovascular Pre-Shaped Prowler Select Infusion Catheters.
- Recall number
- Z-1483-06
- Recalling firm
- Cordis Neurovascular, Inc.
- Product
- Cordis Neurovascular Pre-Shaped Prowler Select 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
- 12 Lot numbers (14,161)
- 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 606S152FX - LOT 13009595; CAT 606S152JX - LOT 13010913; CAT 606S152MX - LOT 13009596; CAT 606S155FX - LOT 13082017; CAT 606S155JX - LOT 13078245; CAT 606S155MX - LOT 13082016; CAT 606S252FX - LOT 13064387; CAT 606S252JX - LOT 13071036; CAT 606S252MX - LOT 13090990; CAT 606S255FX - LOT 13084973; CAT 606S255JX - LOT 13084974; CAT 606S255MX - LOT 13064409
- 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