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Terminated

LeVeen Standard Needle Electrode System, Sterile (3.5/12), (3.5/15), (4.0/15), (3.5/25), (5.0/15), (5.0/25), and (4.0/25). Disposable, monopolar, electrosurgical devices, intended for use in conjunction with BSC radiofrequency generator for the thermal coagulation necrosis of soft tissues, including partial or complete ablation of nonresectable liver lesions.

FDA Recall Z-0079-2013 · Posted 2012-10-18

Recalling FirmBoston Scientific Corporation
Recall StatusTerminated
Product CodeGEI
Date Initiated2012-09-17
Date Terminated2013-07-17
Product Quantity19, 716 total all units

Reason for Recall

Leveen Standard and Leveen Coaccess Needle Electrode System, Directions for Use(DFU) in Portuguese, are incorrect. all other languages in the DFU are correct. Consignees in Brazil, Portugal,and Hong-Kong are being notified.

Firm Action

Boston Scientific sent notifications, dated September 17, 2012, to each account in Brazil, Portugal and Hong Kong affected by the recall. The affected accounts were provided the corrected pages of the Portuguese DFU as part of the communication to ensure that those users that rely on the Portuguese DFU have the correct information.

Root Cause

Labeling Change Control

Distribution Pattern

Distributed in Brazil, Portugal and Hong Kong.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K982556LEVEEN NEEDLE ELECTRODERadiotherapeutics Corp. · 2000-04-06K000032LEVEEN NEEDLE ELECTRODERadiotherapeutics Corp. · 2000-03-30

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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