FDA Medical Device Recalls (openFDA)
Boston Scientific Corp: Boston Scientific, LeVeen Needle Electrode, 25 cm, 5.0 cm, sterile; REF M001262170. For tissue coagulation.
- Recall number
- Z-1877-2009
- Recalling firm
- Boston Scientific Corp
- Product
- Boston Scientific, LeVeen Needle Electrode, 25 cm, 5.0 cm, sterile; REF M001262170. For tissue coagulation.
- Status
- Terminated
- Initiated
- 2009-07-06
- Posted
- 2009-09-09
- Terminated
- 2010-10-08
- Reason
- The tines may detach from the core wire during use, which may result in bleeding or soft tissue trauma requiring medical intervention.
- Root cause
- Process control
- Action
- Boston Scientific notified consignees by letter dated 7/6/09 and instructed to cease using and to return the products, and to complete and return a reply form.
- Quantity
- 347
- Distribution
- Nationwide.
- Lot, serial or model codes
- Lots 8839481, 8900349, 9043740, 9084603, 9296400, 9300554, 9442864, 9531903, 9569178, 9707800, 9746026, 9787308, 11182329, 11203869, 11350192, 11403787, 11518357, 11559944, 12219051 and 12475134.
- 510(k) numbers
- ["K000032"]
- PMA numbers
- not on file
- Product code
- GEI
- Firm FEI
- 1828132
- Firm city
- Spencer
- Firm state
- IN
- 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