Z-1541-05

Boston Scientific brand LeVeen Needle Electrode, 5.0/13/15; Model number M001262160, Ref 26-216

Name: Z-1541-05 Boston Scientific brand LeVeen Needle Electrode, 5.0/13/15; Model number M001262160, Ref 26-216
Creator: Boston Scientific Corp
Published: 2005-07-29
License: https://open.fda.gov/license/

Boston Scientific Corporation / initiated 2005-07-29 / Terminated

FDA source

Boston Scientific Corp began a recall of Boston Scientific brand LeVeen Needle Electrode, 5.0/13/15; Model number M001262160, Ref 26-216 on 2005-07-29. The reason FDA records is "Firm has received complaints of extended ablation times, lack of roll-off and patient burns". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1541-05
Status: Terminated
Initiated: 2005-07-29
Posted: 2005-09-14
Terminated: 2005-12-08
Recalling firm: Boston Scientific Corporation
Product: Boston Scientific brand LeVeen Needle Electrode, 5.0/13/15; Model number M001262160, Ref 26-216.
Product code: GEI Electrosurgical, Cutting & Coagulation & Accessories
Reason for recall: Firm has received complaints of extended ablation times, lack of roll-off and patient burns.
FDA root cause: Other
Action: Distributors and user accounts were notified via medical device correction letter dated 7/29/05.
Distribution: Nationwide, Australia, Brazil, Canada, Hong Kong, Netherlands, Panama, Singapore and Taiwan.
Product codes and lots: Lots 31804, 92702, 6538336, 6538341, 6556258, 6556462, 6556464, 6556634, 6826039, 7002067, 7021736, 7091482, 7108067, 7257089, 7356251, 7422492, 7457364, 7664972, 7667650, 21403R, 21703R and 92702R.

Product code GEI

K982556Class IILeveen Needle ElectrodeRadiotherapeutics Corp. / cleared 2000-04-06

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)