FDA Medical Device Recalls (openFDA)
Boston Scientific Corporation: Banana Peel Sheaths BP/14/15 Catalog Number: 20-609
- Recall number
- Z-1464-05
- Recalling firm
- Boston Scientific Corporation
- Product
- Banana Peel Sheaths BP/14/15 Catalog Number: 20-609
- 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: 6369319 6392604 6412087 6440250 6458182 6502513 6525652 6537822 6552545 6585322 6599018 6620745 6646571 6661841 6697321 6722536 6774278 6803135 6823846 6844314 6854850 6938751 6956397 6973991 7012895 7042711 7069901 7088270 7105143 7196764 7235415 7358084 7382687 7401686 7456767 7469359 7495157 7552030 7571547 7596737 7630036 7639884 7739648
- 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