Belos VR - implantable cardioverter defibrillator. Implantable Cardioverter Defibrillators. The Belos VR is a single-cha
FDA device recall Z-0816-03 · posted 2003-05-14 · Terminated
Recall details
- Recalling firm
- Biotronik Inc
- Reason for recall
- Potential extended charge time anomalies
- Action taken
- 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
- Status
- Terminated
- Product code
- LWS
- Quantity affected
- 469
- Distribution
- The firm distributed to physicians throughout the United States. The firm only distributes to US customers.
- Date initiated
- 2003-03-21
- Date posted
- 2003-05-14
- Date terminated
- 2004-10-13
- Location
- Lake Oswego, OR
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