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
Hazard assessment based on recall description.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
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.
Brand
Biotronik Inc
Lot Codes / Batch Numbers
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
Products Sold
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
Biotronik Inc is recalling Belos VR-T implantable cardioverter defibrillator. Implantable Cardioverter Defibrillator. The Bel due to Potential extended charge time anomalies. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Potential extended charge time anomalies
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026