Cordis Neurovascular, Inc. Cordis Neurovascular Pre-Shaped PROWLER Infusion Catheters. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Cordis Neurovascular Pre-Shaped PROWLER Infusion Catheters.
Brand
Cordis Neurovascular, Inc.
Lot Codes / Batch Numbers
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.
Products Sold
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.
Cordis Neurovascular, Inc. is recalling Cordis Neurovascular Pre-Shaped PROWLER Infusion Catheters. due to Sterility (package integrity) compromised-Cordis Neurovascular, Inc. discovered, during internal testing, that some catheters within the affected lots. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
All consignees were notified by letter on 8/14/06. All Cordis Neurovascular sales representatives will also participate, to ensure expedited communication.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026