Cordis Neurovascular Pre-Shaped Prowler Select Infusion… recallZ-1483-06 · Cordis Neurovascular, Inc. · initiated Aug 11, 2006
Terminated All recalls posted in September 2006
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Cordis Neurovascular, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
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.
FDA root cause category: Other
What the company is doing
All consignees were notified by letter on 8/14/06. All Cordis Neurovascular sales representatives will also participate, to ensure expedited communication.
Recall details
- Recall number
- Z-1483-06
- Recall class
- Not yet classified by the FDA
- Status
- Terminated
- Initiated by the company
- Aug 11, 2006
- Posted by the FDA
- Sep 2, 2006
- Recalling firm
- Cordis Neurovascular, Inc.
- Quantity
- 12 Lot numbers (14,161)
- Product code
- KRA
- FDA submissions
- K021591
- Distribution
- Class II Recall - Worldwide distribution --- including USA and countries of Asia Pacific, Europe, Latin America, Canada, Japan and Australia.
Product description
Cordis Neurovascular Pre-Shaped Prowler Select Infusion Catheters.
Code information (models, lots, serial numbers)
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
Other devices under the same FDA submission
9 devices cleared under K021591 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- PROWLER SELECT 606-S255XMedos International Sàrl · Catheter, continuous flush2 deaths980 reports
- PROWLER SELECT 606-S255FXMedos International Sàrl · Catheter, continuous flush43 reports
- PROWLER SELECT 606-S155FXMedos International Sàrl · Catheter, continuous flush13 reports
- PROWLER SELECT 606-S155XMedos International Sàrl · Catheter, continuous flush13 reports
- PROWLER SELECT 606-S252Medos International Sàrl · Catheter, continuous flush1 death8 reports
- PROWLER SELECT 606-S272XMedos International Sàrl · Catheter, continuous flush4 reports
- PROWLER SELECT 606-S155JXMedos International Sàrl · Catheter, continuous flush2 reports
- PROWLER SELECT 606-S255MXMedos International Sàrl · Catheter, continuous flush2 reports
- PROWLER SELECT 606-S252XMedos International Sàrl · Catheter, continuous flush1 report
Other products in the same recall event
The FDA groups related products into one recall event (event 36077).
- Z-1482-06 · TerminatedCordis Neurovascular Pre-Shaped PROWLER Infusion Catheters.
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
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