FDA Medical Device Recalls (openFDA)
Boston Scientific Corporation: Banana Peel Sheaths - 12/30 Catalog Number: 260202
- Recall number
- Z-1519-05
- Recalling firm
- Boston Scientific Corporation
- Product
- Banana Peel Sheaths - 12/30 Catalog Number: 260202
- Status
- Terminated
- Initiated
- 2005-07-22
- Posted
- 2005-09-02
- Terminated
- 2007-06-20
- Reason
- The Tearaway Introducer Sheath may have cracked hubs/handles and/or improper peeling during use.
- Root cause
- Other
- Action
- 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.
- Quantity
- not on file
- Distribution
- Nationwide VA Hopsitals Foreign: Canada, Africa, Japan, Israel, Japan, Nertherlands, Venezula
- Lot, serial or model codes
- Lot Numbers: 6444381 6525630 6560012 6661823 6779586 6815890 6918043 6952320 7031120 7069893 7152743 7196772 7348602 7425886 7472852 7495147
- 510(k) numbers
- ["K961219"]
- PMA numbers
- not on file
- Product code
- KOB
- Firm FEI
- 3001451463
- Firm city
- Natick
- Firm state
- MA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28