Rivacor 5 HF-T QP DF4 IS4 ProMRI 429561Recalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 04035479156879), received between Jan 10, 2020 and Jun 8, 2026 — classified as 1 death, 11 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Inappropriate/Inadequate Shock/Stimulation” (2 reports).

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

Recent adverse event reports

The 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• InjuryJun 8, 2026Adverse Event Without Identified Device or Use Problem

  SYSTEM WAS EXPLANTED DUE TO SUSPECTED INFECTION. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THIS FILE WILL BE UPDATED.

  Patient problems: Unspecified Infection

  MAUDE report 25427908 ↗
• InjuryJun 30, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED POSTOPERATIVELY THAT A WOUND DEHISCENCE WAS OBSERVED. THE PATIENT WAS HOSPITALIZED. WOUND TREATMENT AND DISINFECTION WERE DONE. THE ICD LEAD WAS RELOCATED BEHIND THE DEVICE. DEVICE REMAINS IMPLANTED. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THIS FILE WILL BE UPDATED.

  Patient problems: Wound Dehiscence

  MAUDE report 14881107 ↗
• InjuryJun 22, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  TWO WEEKS AFTER IMPLANTATION THE PATIENT SUFFERED FROM AN INFECTION AND WAS HOSPITALIZED. THE PATIENT WAS GIVEN I.V. ANTIBIOTIC TREATMENT AND THE CRT-D WAS EXTRACTED. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THIS FILE WILL BE UPDATED.

  Patient problems: Unspecified Infection

  MAUDE report 14784141 ↗
• InjuryJun 7, 2022Inappropriate/Inadequate Shock/Stimulation; Inappropriate/Inadequate Shock/Stimulation

  AFTER AN IMPLANTATION PERIOD OF APPROX. 12 MONTHS, IT WAS OBSERVED THAT THE PATIENT RECEIVED AN INAPPROPRIATE SHOCK FROM THE CRT. DEVICE REMAINS IMPLANTED. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THIS FILE WILL BE UPDATED.

  Patient problems: Shock

  MAUDE report 14620995 ↗
• MalfunctionMay 3, 2022High impedance; Loose or Intermittent Connection; Ambient Noise Problem; High impedance; Loose or Intermittent Connection; Ambient Noise Problem

  IMPEDANCE HIGHER THAN 3000 OHM AND NOISE DETECTION WERE SEEN. AN RV LEAD ISSUE HAS BEEN RULED OUT. A FAILURE OF THE DEVICE HEADER WAS REPORTED. DEVICE WAS EXPLANTED AND REPLACED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14271209 ↗
• InjuryMar 30, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT SUFFERED FROM SYSTEMIC FEVER AND INFECTION IN THE AREA OF PACEMAKER. (B)(6)WAS FOUND. CRT-D AND ELECTRODES WERE REMOVED.

  Patient problems: Unspecified Infection

  MAUDE report 13953838 ↗
• InjuryFeb 16, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT SUFFERED FROM POCKET INFECTION. THE PATIENT WAS HOSPITALIZED. SYSTEM WAS EXPLANTED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS FILE WILL BE UPDATED.

  Patient problems: Unspecified Infection

  MAUDE report 13541937 ↗
• InjurySep 14, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AFTER AN IMPLANTATION PERIOD OF APPROXIMATELY 2 MONTHS, IT WAS REPORTED THAT THE PATIENT WAS DIAGNOSED WITH MULTI-STAGE THROMBOSIS OF THE SUBCLAVIAN VEIN. ORAL ANTICOAGULATION THERAPY WAS RECOMMENDED FOR AT LEAST 3-6 MONTHS.

  Patient problems: Thrombosis/Thrombus

  MAUDE report 12467688 ↗
• DeathAug 9, 2021Failure to Convert Rhythm; Failure to Convert Rhythm

  27 DAYS AFTER IMPLANTATION IT WAS REPORTED THAT THE PATIENT DIED AFTER AN ELECTRICAL STORM AND UNSUCCESSFUL REANIMATION.

  Patient problems: Ventricular Fibrillation

  MAUDE report 12294048 ↗
• InjuryMar 24, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT SUFFERED FROM A LARGE HEMATOMA AFTER CRT IMPLANTATION. THE INVESTIGATOR ASSESSED THIS EVENT AS POSSIBLE RELATED TO THE PATIENTS MEDICAL HISTORY AND CONCOMITANT MEDICATION WITH APIXABAN 2.5MG. THE PATIENT WAS HOSPITALIZED. ANALGESIC AS NEEDED AND NOVALGIN PILLS WERE GIVEN.

  Patient problems: Hematoma

  MAUDE report 11565767 ↗
• MalfunctionMar 22, 2021Failure to Interrogate; Failure to Interrogate

  IT WAS REPORTED THAT THIS DEVICE COULD NOT BE INTERROGATED. THE DEVICE WAS EXPLANTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11547449 ↗
• InjuryOct 16, 2020Loose or Intermittent Connection; Inappropriate/Inadequate Shock/Stimulation; Loose or Intermittent Connection; Inappropriate/Inadequate Shock/Stimulation

  IT WAS REPORTED THAT APPROX. 15 DAYS AFTER THE IMPLANTATION THERE MAY BE AN INAPPROPRIATE SHOCK DUE TO A CRT-D FAILURE. FURTHERMORE, PATIENT WAS DIAGNOSED WITH HYPERKALEMIA. THE PATIENT WAS HOSPITALIZED AND PULSE GENERATOR REPROGRAMMING WAS DONE. FOR DIAGNOSTIC REASONS CHEST X-RAY AND BLOOD TESTS WERE DONE. PATIENT WAS TREATED WITH ANTIBIOTICS AND TREATMENT WITH ALDACTONE WAS STOPPED. PATIENT GOT A SURGICAL INTERVENTION (SECURING SCREW CONNECTION OF RV LEAD TO CRTD).

  Patient problems: Shock from Patient Lead(s)

  MAUDE report 10693184 ↗
• InjuryJul 2, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT SUFFERED FROM A POST-INTERVENTIONAL PNEUMOTHORAX. THE PATIENT WAS HOSPITALIZED AND A SUCTION DRAIN WAS IMPLANTED IN THE MONALDI POSITION LEFT. FOR DIAGNOSTICS AN X-RAY WAS DONE.

  Patient problems: Pneumothorax

  MAUDE report 10227365 ↗
• InjuryJan 10, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A REVISION OF THE CRT SYSTEM WAS PERFORMED. HOWEVER, THE TISSUE WAS UNUSUALLY SOFT AND ALTERED, GIVING THE CLINICAL IMPRESSION OF A POSSIBLE CHRONIC WOUND INFECTION. THE MICROBIOLOGICAL TESTING OF THE SMEAR DID NOT SHOW ANY BACTERIA OR FUNGUS. THE REVISION WAS COMPLICATED BY EXCESSIVE BLEEDING. THE INVESTIGATOR ASSESSED THIS AS A POSSIBLE CHRONIC PACEMAKER WOUND INFECTION. WOUND DEBRIDEMENT WAS PERFORMED AND AN INTRAOPERATIVE SMEAR WAS TAKEN. COAGULATION WAS PERFORMED TO STOP BLEEDING. PATIENT WAS PRESCRIBED A PROLONGED COURSE OF ANTIBIOTICS AFTER CRT REVISION.

  Patient problems: Unspecified Infection

  MAUDE report 9574559 ↗