Boston Scientific Corporation Vaxcel Implantable Chest Ports With PASV Valve Technology - Vaxcel w/PASV Mini/T/PU/6/1.1/1.9/63 Catalog Number : 45-213 Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Vaxcel Implantable Chest Ports With PASV Valve Technology - Vaxcel w/PASV Mini/T/PU/6/1.1/1.9/63 Catalog Number : 45-213
Brand
Boston Scientific Corporation
Lot Codes / Batch Numbers
Lot Numbers: 929652 958506 959672 960718 970274 979014 979328 986234 1001729 1028094 1030285
Products Sold
Lot Numbers: 929652 958506 959672 960718 970274 979014 979328 986234 1001729 1028094 1030285
Boston Scientific Corporation is recalling Vaxcel Implantable Chest Ports With PASV Valve Technology - Vaxcel w/PASV Mini/T/PU/6/1.1/1.9/63 Cat 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