Boston Scientific Corporation Vaxcel Plus Chronic Dialysis Catheters - Catheter/CPU/15/19/Metal Catalog Number : 45-540 Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Vaxcel Plus Chronic Dialysis Catheters - Catheter/CPU/15/19/Metal Catalog Number : 45-540
Brand
Boston Scientific Corporation
Lot Codes / Batch Numbers
Not specified in FDA notice. Check official source for details.
Products Sold
Lot Number: 982188 993808 993809 993810 993811 1000932 1000933 1000934 1001751 1002365 1009150 1018968 1020892 1027102 1027103 1027104 1027105 1027106
Boston Scientific Corporation is recalling Vaxcel Plus Chronic Dialysis Catheters - Catheter/CPU/15/19/Metal Catalog Number : 45-540 due to The Tearaway Introducer Sheath may have cracked hubs/handles and/or improper peeling during use.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
The Tearaway Introducer Sheath may have cracked hubs/handles and/or improper peeling during use.
Recommended Action
Per FDA guidance
Boston Scientific intiated the recall on 7/22/05 to direct accounts and to distributors on 7/ 27 /05. Distributors are requested to conduct sub recalls to the medical facility level. A revised letter dated 8/2/05 was sent to 18 US accounts for one lot (#1020895) omitted in the letter of 7/22/05.
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