Rivacor 3 HF-T QP DF4 IS4 ProMRI 429571Recalls & 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
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 04035479156978), received between Apr 24, 2019 and Nov 15, 2021 — classified as 1 injury, 1 malfunction.
The most frequently reported specific device problem is “Delayed Charge Time” (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
- Delayed Charge Time1
- Device Dislodged or Dislocated1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
- Pneumothorax1
- Vascular Dissection1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionNov 15, 2021Delayed Charge Time; Delayed Charge Time
AFTER AN IMPLANTATION PERIOD OF APPROX. 27 MONTHS, IT WAS OBSERVED THAT THE CHARGING TIME WAS TOO LONG. THE ICD WAS EXPLANTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12817236 ↗InjuryApr 24, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated
OUS MDR - THE PATIENT SUFFERED FROM A HEMOPNEUMOTHORAX ON THE LEFT SIDE AFTER CRT-D IMPLANTATION AND A DIFFUSE BLEEDING OF THE CHEST WALL IN THE AREA OF THE CLAVICLE WAS RECOGNIZED. DURING THE IMPLANTATION TWO DISSECTIONS OF THE CORONARY SINUS WERE DESCRIBED DUE TO DISLODGEMENT OF THE WHOLE SYSTEM TWO TIMES. THE PATIENT WAS HOSPITALIZED. CT SCAN WAS PERFORMED FOR DIAGNOSTIC REASONS. A THORACOTOMY WAS DONE AND THE HEMATOMA REMOVED. ANTIBIOTICS WERE GIVEN PERIOPERATIVE. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THIS FILE WILL BE UPDATED.
Patient problems: Pneumothorax; Vascular Dissection
MAUDE report 8547483 ↗
Other Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D) devices
- Gallant™ CDHFA500QSt. Jude Medical, Inc. · Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)2 recalls58 deaths8,401 reports
- Quartet™ 1458Q-86St. Jude Medical, Inc. · Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)207 deaths6,631 reports
- QUADRA ASSURA MP™ CD3369-40QSt. Jude Medical, Inc. · Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)103 deaths6,084 reports
- VIGILANT™ X4 CRT-D G247Boston Scientific Corporation · Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)17 deaths2,066 reports
- Quadra Assura™ CD3365-40QSt. Jude Medical, Inc. · Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)53 deaths2,056 reports
- Cobalt™ XT HF Quad CRT-D MRI SureScan™ DTPA2QQMedtronic, Inc. · Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)4 recalls40 deaths1,639 reports
- Unify Assura™ CD3357-40QSt. Jude Medical, Inc. · Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)54 deaths1,784 reports
- Unify Assura™ CD3357-40CSt. Jude Medical, Inc. · Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)56 deaths1,588 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.
How reports and recalls are matched · Editorial policy · Report an error on this page