FDA Medical Device Recalls (openFDA)
Boston Scientific Corp: Boston Scientific brand LeVeen Needle Electrode, 5.0/13/25; Model number M001262170,Ref 26-217.
- Recall number
- Z-1542-05
- Recalling firm
- Boston Scientific Corp
- Product
- Boston Scientific brand LeVeen Needle Electrode, 5.0/13/25; Model number M001262170,Ref 26-217.
- Status
- Terminated
- Initiated
- 2005-07-29
- Posted
- 2005-09-14
- Terminated
- 2005-12-08
- Reason
- Firm has received complaints of extended ablation times, lack of roll-off and patient burns.
- Root cause
- Other
- Action
- Distributors and user accounts were notified via medical device correction letter dated 7/29/05.
- Quantity
- not on file
- Distribution
- Nationwide, Australia, Brazil, Canada, Hong Kong, Netherlands, Panama, Singapore and Taiwan.
- Lot, serial or model codes
- Lots 7417267, 7481332 and 7606569.
- 510(k) numbers
- ["K982556"]
- 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