Boston Scientific Corporation Banana Peel Sheaths BP/16/15 Catalog NUmber : 20-610 Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Banana Peel Sheaths BP/16/15 Catalog NUmber : 20-610
Brand
Boston Scientific Corporation
Lot Codes / Batch Numbers
Not specified in FDA notice. Check official source for details.
Products Sold
Lot Numbers: 6823847 6837612 6854851 6887568 6896412 6956415 7124100 7172813 7196765 7235401 7330324 7355512 7382529 7401694 7401860 7456768 7472843 7495201 7514119
Boston Scientific Corporation is recalling Banana Peel Sheaths BP/16/15 Catalog NUmber : 20-610 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