FDA Medical Device Recalls (openFDA)
Biotronik Inc: Belos VR-T implantable cardioverter defibrillator. Implantable Cardioverter Defibrillator. The Belos VR-T 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.
- Recall number
- Z-0817-03
- Recalling firm
- Biotronik Inc
- Product
- Belos VR-T implantable cardioverter defibrillator. Implantable Cardioverter Defibrillator. The Belos VR-T 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.
- Status
- Terminated
- Initiated
- 2003-03-21
- Posted
- 2003-05-14
- Terminated
- 2004-10-13
- Reason
- Potential extended charge time anomalies
- Root cause
- Other
- 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.
- Quantity
- 49
- Distribution
- The firm distributed to physicians throughout the United States. The firm only distributes to US customers.
- Lot, serial or model codes
- Part number 331135. Serial numbers 78140020, 78140021, 78140026, 78140027, 78140029, 78140035, 78140037, 78140038, 78140039, 78140045, 78140046, 78140048, 78140049, 78140051, 78140052, 78140053, 78140054, 78140055, 78140056, 78140057, 78140058, 78140059, 78140060, 78140061, 78140062, 78140063, 78140064, 78140065, 78140066, 78140067, 78140070, 78140071, 78140072, 78140073, 78140102, 78140103, 78140104, 78140105, 78140109, 78140111, 78140112, 78140113, 78140114, 78140124, 78140132, 78140134, 78140135, 78140136, 78140139
- 510(k) numbers
- not on file
- PMA numbers
- ["P980023/S8"]
- Product code
- LWS
- Firm FEI
- 1028232
- Firm city
- Lake Oswego
- Firm state
- OR
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28