Z-2094-2008

Boston Scientific LeVeen SuperSlim Needle Electrode, 3.0 cm/25 cm, sterile. The device is intended to be used...

Name: Z-2094-2008 Boston Scientific LeVeen SuperSlim Needle Electrode, 3.0 cm/25 cm, sterile. The device is intended to be used...
Creator: Boston Scientific Corp
Published: 2007-10-01
License: https://open.fda.gov/license/

Boston Scientific Corporation / initiated 2007-10-01 / Terminated / root cause: design

FDA source

Boston Scientific Corp began a recall of Boston Scientific LeVeen SuperSlim Needle Electrode, 3.0 cm/25 cm, sterile. The device is intended to be used in conjunction with a Radio Therapeutics... on 2007-10-01. 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-2094-2008
Status: Terminated
Initiated: 2007-10-01
Posted: 2008-09-16
Terminated: 2008-09-16
Recalling firm: Boston Scientific Corporation
Product: Boston Scientific LeVeen SuperSlim Needle Electrode, 3.0 cm/25 cm, sterile. The device is intended to be used in conjunction with a Radio Therapeutics Corporation radiofrequency (RF) generator for thermal coagulation necrosis of soft tissue, 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: Customer notifications were sent to customers in Japan on October 1, 2007 instructing them to check their inventory and to return affected product. Contact Rob Miragliuolo at 508-683-4186 if you have questions.
Quantity in commerce: 15,604 of all products
Distribution: Japan.
Product codes and lots: All lots.

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)