Rivacor 5 VR-T DX DF4 ProMRI 429564Recalls & reported problems
BIOTRONIK SE & Co. KG · Class 3 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 04035479156909), received between Aug 31, 2020 and Jul 28, 2021 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Failure to Transmit Record” (1 report).
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Most reported problems
Device problems
- Failure to Transmit Record1
- Pacemaker Found in Back-Up Mode1
- Premature End-of-Life Indicator1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionJul 28, 2021Pacemaker Found in Back-Up Mode; Failure to Transmit Record; Pacemaker Found in Back-Up Mode; Failure to Transmit Record
ON (B)(6) 2021 THE ICD STOPPED TRANSMITTING TO HOME MONITORING. WE TESTED ALL THE POSSIBILITIES AND CHANGED THE CARDIO MESSENGER OF THE PATIENT. ON (B)(6), FOLLOW UP WAS NOT SUCCESSFUL. DEVICE IN BACKUP MODE, UNABLE TO BE REINITIALIZED. DEVICE WAS EXPLANTED AND RETURNED, BUT AN EXPLANT DATE WAS NOT PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12238719 ↗MalfunctionAug 31, 2020Premature End-of-Life Indicator; Premature End-of-Life Indicator
AFTER AN IMPLANTATION PERIOD OF APPROX. 10 MONTHS, IT WAS REPORTED THAT THE DEVICE SHOWS THE EOS STATUS. THE PATIENT WAS HOSPITALIZED AND THE ICD WAS EXPLANTED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 10474422 ↗
Other Implantable cardioverter defibrillator (non-CRT) devices
- EMBLEM™ MRI S-ICD A219Boston Scientific Corporation · Implantable cardioverter defibrillator (non-CRT)2 recalls36 deaths15,404 reports
- EMBLEM™ S-ICD A209Boston Scientific Corporation · Implantable cardioverter defibrillator (non-CRT)1 recall7 deaths6,788 reports
- EMBLEM™ S-ICD 3501Boston Scientific Corporation · Implantable cardioverter defibrillator (non-CRT)7 deaths4,936 reports
- Cobalt™ XT DR MRI SureScan™ DDPA2D4Medtronic, Inc. · Implantable cardioverter defibrillator (non-CRT)3 recalls30 deaths1,603 reports
- ENDOTAK RELIANCE® G 0185Boston Scientific Corporation · Implantable cardioverter defibrillator (non-CRT)9 deaths1,632 reports
- VIGILANT™ EL ICD DR D233Boston Scientific Corporation · Implantable cardioverter defibrillator (non-CRT)9 deaths1,563 reports
- Evera MRI™ XT DR SureScan® DDMB1D4Medtronic, Inc. · Implantable cardioverter defibrillator (non-CRT)1 recall35 deaths1,426 reports
- Durata™ 7122St. Jude Medical, Inc. · Implantable cardioverter defibrillator (non-CRT)27 deaths1,377 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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