Boston Scientific Corporation Silicone Central Venous Catheter with PASV Valve and Polyester Cuff - 6.6F. Boston Scientific Cat. #CVC661IK M001CVC661IK0. Firm on label: Boston Scientific Corporation, NAMIC Technology Center, Glens Falls, NY 12801. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Silicone Central Venous Catheter with PASV Valve and Polyester Cuff - 6.6F. Boston Scientific Cat. #CVC661IK M001CVC661IK0. Firm on label: Boston Scientific Corporation, NAMIC Technology Center, Glens Falls, NY 12801.
Brand
Boston Scientific Corporation
Lot Codes / Batch Numbers
1009520, 1009824, 1011813, 1013925, 1018980, 1021339, 1022517, 1022952
Products Sold
1009520, 1009824, 1011813, 1013925, 1018980, 1021339, 1022517, 1022952
Boston Scientific Corporation is recalling Silicone Central Venous Catheter with PASV Valve and Polyester Cuff - 6.6F. Boston Scientific Cat. due to Device kits contain B. Braun Locking Tearaway Introducer Systems labeled as 7Fr but may contain 8 Fr sheaths.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Device kits contain B. Braun Locking Tearaway Introducer Systems labeled as 7Fr but may contain 8 Fr sheaths.
Recommended Action
Per FDA guidance
Boston Scientific letter dated 10/28/2005 sent via Federal Express. Customers (hospitals) instructed to remove and return product.
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