Z-1914-2008

Boston Scientific LeVeen SuperSlim Needle Electrode, 2.0 cm/25 cm, sterile, Boston Scientific, Spencer, IN...

Name: Z-1914-2008 Boston Scientific LeVeen SuperSlim Needle Electrode, 2.0 cm/25 cm, sterile, Boston Scientific, Spencer, IN...
Creator: Boston Scientific Corp
Published: 2008-04-30
License: https://open.fda.gov/license/

Boston Scientific Corporation / initiated 2008-04-30 / Terminated / root cause: design

FDA source

Boston Scientific Corp began a recall of Boston Scientific LeVeen SuperSlim Needle Electrode, 2.0 cm/25 cm, sterile, Boston Scientific, Spencer, IN; REF 26-227, UPN M001262270. The product is used... on 2008-04-30. The reason FDA records is "The cannula may become detached from its correct orientation inside the handle and may prevent retraction of the tines". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-1914-2008
Status: Terminated
Initiated: 2008-04-30
Posted: 2008-09-11
Terminated: 2009-08-04
Recalling firm: Boston Scientific Corporation
Product: Boston Scientific LeVeen SuperSlim Needle Electrode, 2.0 cm/25 cm, sterile, Boston Scientific, Spencer, IN; REF 26-227, UPN M001262270. The product is used with radiofrequency generator for the thermal coagulation necrosis of soft tissues,including partial or complete ablation of nonresectable liver lesions.
Product code: GEI Electrosurgical, Cutting & Coagulation & Accessories
Reason for recall: The cannula may become detached from its correct orientation inside the handle and may prevent retraction of the tines.
Root cause tag: design
FDA root cause: Device Design
Action: Consignees were notified by recall letter on 4/30/08, sent fexex priority mail, to cease use of the products and to return them to the firm. For assistance, contact Boston Scientific at 1-508-683-4186.
Quantity in commerce: 1,356
Distribution: Nationwide, Argentina, Belgium, Canada, Czech Republic, Egypt, Finland, France, Germany, Great Britain, Hong Kong, Hungary, Iraq, Ireland, Italy, Jordan, Korea, Lebanon, Malaysia, Netherlands, New Zealand, Norway, Poland, Portugal, Singapore, Spain, Sweden, Switzerland, Taiwan, Thailand, and United Arab Emirates.
Product codes and lots: All lots (Lots 0007754222, 0007757352, 0007774377, 0007778866, 0007787319, 0007802363, 0007819373, 0008025066, 0008033462, 0008119925, 0008126720, 0008139108, 0008167709, 0008187490, 0008189883, 0008191619, 0008272777, 0008274731, 0008301843, 0008900347, 0009106193, 0009261704, 0009261705, 0009261706, 0009275205, 0009292249, 0009344591, 0009382115, 0009422549, 0009437649, 0009446512, 0009464930, 0009505685, 0009532051, 0009569176, 0009595712, 0009647788, 0009663657, 0009749621, 0009783669, 0009799393, 0009993406 0011311216 and 0011517938.)

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