Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

Terminated

Boston Scientific brand LeVeen Needle Electrode, 5.0/13/15; Model number M001262160, Ref 26-216.

FDA Recall Z-1541-05 · 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.

↑