FDA Medical Device Recalls (openFDA)
Boston Scientific Corp: Boston Scientific brand Concerto Bipolar Needle Electrode, sterile, latex free, Model M001262400, catalog number 26-240.
- Recall number
- Z-1456-05
- Recalling firm
- Boston Scientific Corp
- Product
- Boston Scientific brand Concerto Bipolar Needle Electrode, sterile, latex free, Model M001262400, catalog number 26-240.
- Status
- Terminated
- Initiated
- 2005-07-15
- Posted
- 2005-08-31
- Terminated
- 2007-02-07
- Reason
- The distal tip may dislodge from the device during use and the firm has received complaints of electrical errors.
- Root cause
- Other
- Action
- Consignees were advised by recall letter dated July 25, 2005 and requested to return all units on hand.
- Quantity
- 115
- Distribution
- Nationwide, Germany, Italy, Netherlands, Spain and Sweden.
- Lot, serial or model codes
- Lots 7575613, 7583594, 7715339 and 7730068.
- 510(k) numbers
- not on file
- 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