Boston Scientific Corporation Vaxcel Chest Ports - Standard/PS/S/8/1.5/2.6/63 Catalog Number : 45-340 Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Vaxcel Chest Ports - Standard/PS/S/8/1.5/2.6/63 Catalog Number : 45-340
Brand
Boston Scientific Corporation
Lot Codes / Batch Numbers
Not specified in FDA notice. Check official source for details.
Products Sold
Lot Numbers: 922095 941338 942508 953633 958510 968286 971539 982184 991606 996601 1000907 1001280 968286D
Boston Scientific Corporation is recalling Vaxcel Chest Ports - Standard/PS/S/8/1.5/2.6/63 Catalog Number : 45-340 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