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Terminated

Boston Scientific brand LeVeen Needle Electrode, 5.0/13/25; Model number M001262170,Ref 26-217.

FDA Recall Z-1542-05 · Posted 2005-09-14

Recalling FirmBoston Scientific Corp
Recall StatusTerminated
Product CodeGEI
Date Initiated2005-07-29
Date Terminated2005-12-08

Reason for Recall

Firm has received complaints of extended ablation times, lack of roll-off and patient burns.

Firm Action

Distributors and user accounts were notified via medical device correction letter dated 7/29/05.

Root Cause

Other

Distribution Pattern

Nationwide, Australia, Brazil, Canada, Hong Kong, Netherlands, Panama, Singapore and Taiwan.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K982556LEVEEN NEEDLE ELECTRODERadiotherapeutics Corp. · 2000-04-06

Official Source

View FDA Recall →

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

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