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Terminated

Belos VR - implantable cardioverter defibrillator. Implantable Cardioverter Defibrillators. The Belos VR is a single-chamber implantable cardioverter defibrillator (ICD) that detects and treats ventricular tachyarrhythmias and provides rate adaptive bradycardia pacing support. The ICDs are designed to collect diagnostic data to aid the physician''s assessment of a patient''s condition and the performance of the implanted device.

FDA Recall Z-0816-03 · Posted 2003-05-14

Recalling FirmBiotronik Inc
Recall StatusTerminated
Product CodeLWS
Date Initiated2003-03-21
Date Terminated2004-10-13
Product Quantity469

Reason for Recall

Potential extended charge time anomalies

Firm Action

The firm issued a letter dated 3/21/03 via certified return receipt requested. The envelope and letter are flagged 'IMPORTANT: Patient Management Information'. The letter recommends that physicians schedule an immediate follow-up visit with each of their patients implanted with an affected Belos VR or VR-T ICD to evaluate the device charge times. The firm provided the doctors with the names of their patients.

Root Cause

Other

Distribution Pattern

The firm distributed to physicians throughout the United States. The firm only distributes to US customers.

Official Source

View FDA Recall →

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

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