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Terminated

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

FDA Recall Z-1876-2009 · Posted 2009-09-09

Recalling FirmBoston Scientific Corp
Recall StatusTerminated
Product CodeGEI
Date Initiated2009-07-06
Date Terminated2010-10-08
Product Quantity2,774

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.

Firm 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.

Root Cause

Process control

Distribution Pattern

Nationwide.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K000032LEVEEN 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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