Boston Scientific Corporation Banana Peel Sheaths BP/11/30 Catalog Number : 20-613 Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Banana Peel Sheaths BP/11/30 Catalog Number : 20-613
Brand
Boston Scientific Corporation
Lot Codes / Batch Numbers
Not specified in FDA notice. Check official source for details.
Products Sold
Lot Numbers: 6823849 6844365 6854853 6952318 7031134 7069902 7088276 7105144 7152741 7171681 7196768
Boston Scientific Corporation is recalling Banana Peel Sheaths BP/11/30 Catalog Number : 20-613 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