Z-1456-05

Boston Scientific brand Concerto Bipolar Needle Electrode, sterile, latex free, Model M001262400, catalog...

Name: Z-1456-05 Boston Scientific brand Concerto Bipolar Needle Electrode, sterile, latex free, Model M001262400, catalog...
Creator: Boston Scientific Corp
Published: 2005-07-15
License: https://open.fda.gov/license/

Boston Scientific Corporation / initiated 2005-07-15 / Terminated

FDA source

Boston Scientific Corp began a recall of Boston Scientific brand Concerto Bipolar Needle Electrode, sterile, latex free, Model M001262400, catalog number 26-240 on 2005-07-15. The reason FDA records is "The distal tip may dislodge from the device during use and the firm has received complaints of electrical errors". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1456-05
Status: Terminated
Initiated: 2005-07-15
Posted: 2005-08-31
Terminated: 2007-02-07
Recalling firm: Boston Scientific Corporation
Product: Boston Scientific brand Concerto Bipolar Needle Electrode, sterile, latex free, Model M001262400, catalog number 26-240.
Product code: GEI Electrosurgical, Cutting & Coagulation & Accessories
Reason for recall: The distal tip may dislodge from the device during use and the firm has received complaints of electrical errors.
FDA root cause: Other
Action: Consignees were advised by recall letter dated July 25, 2005 and requested to return all units on hand.
Quantity in commerce: 115
Distribution: Nationwide, Germany, Italy, Netherlands, Spain and Sweden.
Product codes and lots: Lots 7575613, 7583594, 7715339 and 7730068.

Product code GEI

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)