Z-1876-2009

Boston Scientific, LeVeen Needle Electrode, 15 cm, 5.0 cm, sterile; REF M001262160. For tissue coagulation

Name: Z-1876-2009 Boston Scientific, LeVeen Needle Electrode, 15 cm, 5.0 cm, sterile; REF M001262160. For tissue coagulation
Creator: Boston Scientific Corp
Published: 2009-07-06
License: https://open.fda.gov/license/

Boston Scientific Corporation / initiated 2009-07-06 / Terminated / root cause: manufacturing process

FDA source

Boston Scientific Corp began a recall of Boston Scientific, LeVeen Needle Electrode, 15 cm, 5.0 cm, sterile; REF M001262160. For tissue coagulation on 2009-07-06. The reason FDA records is "The tines may detach from the core wire during use, which may result in bleeding or soft tissue trauma requiring medical intervention". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1876-2009
Status: Terminated
Initiated: 2009-07-06
Posted: 2009-09-09
Terminated: 2010-10-08
Recalling firm: Boston Scientific Corporation
Product: Boston Scientific, LeVeen Needle Electrode, 15 cm, 5.0 cm, sterile; REF M001262160. For tissue coagulation.
Product code: GEI Electrosurgical, Cutting & Coagulation & Accessories
Reason for recall: The tines may detach from the core wire during use, which may result in bleeding or soft tissue trauma requiring medical intervention.
Root cause tag: manufacturing process
FDA 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 in commerce: 2,774
Distribution: Nationwide.
Product codes and lots: Lots 8745076, 8745077, 8745078, 8745082, 8745083, 8764662, 8764663, 8840136, 8840210, 8888632, 8922046, 8922047, 8922048, 8925499, 8946944, 8952359, 8960112, 8991516, 9007921, 9023847, 9051903, 9063250, 9080980, 9103385, 9103712, 9103713, 9103714, 9135758, 9153911, 9160547, 9275203, 9288929, 9300199, 9303597, 9406392, 9447228, 9464347, 9484064, 9502208, 9516123, 9591056, 9629225, 9643197, 9659590, 9708545, 9727738, 9763201, 9776097, 9783671, 11001461, 11005784, 11034758, 11042785, 11091132, 11114016, 11128377, 11128379, 11178425, 11203868, 11230657, 11356155, 11403788, 11440970, 11460060, 11551315, 11580328, 11620899, 11711276, 11766589, 11851200, 11881851, 11900344, 11916630, 11931597, 11943359, 11947005, 12324021, 12450298, 12517661 and 12621268.

Product code GEI

K000032Class IILeveen Needle ElectrodeRadiotherapeutics Corp. / cleared 2000-03-30

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 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)