RESONATE™ HF CRT-D G547Recalls & reported problems

Summary

The FDA's MAUDE database contains 542 adverse event reports that list this exact device (DI 00802526589744), received between Apr 22, 2022 and Sep 30, 2026 — classified as 1 death, 303 injuries, 238 malfunctions.

The most frequently reported specific device problem is “Over-Sensing” (127 reports).

19 other recalls cover devices cleared under the same FDA submission (P010012); they may or may not involve this specific model.

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 25 most recent of 542 reports, in the reporter's own words as published by the FDA.

• InjurySep 30, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Unspecified Infection

  MAUDE report 50953257 ↗
• MalfunctionSep 30, 2026Signal Artifact/Noise; Over-Sensing

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50949200 ↗
• MalfunctionSep 30, 2026Premature Discharge of Battery

  It was reported that this cardiac resynchronization therapy defibrillator (CRT-D) recorded a Code 1003 indicative of battery voltage too low for the projected remaining capacity. A request was made to have data from this device analyzed. Data analysis low voltage fault and that this device power consumption was increasing in a gradual fashion. Device replacement was recommended. To date, this device remains in service. No adverse patient effects were reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50943564 ↗
• InjurySep 30, 2026Signal Artifact/Noise; Over-Sensing; Pacing Problem; Inappropriate/Inadequate Shock/Stimulation; Use of Device Problem

  It was reported that this cardiac resynchronization therapy defibrillator (CRT-D) system delivered anti-tachycardia pacing (ATP) and two shocks due oversensed electromagnetic interference (EMI) noise from electrocautery during an unrelated breast surgery. It was determined that a magnet was not applied prior to the surgery. After the procedure, review of device data showed successful threshold tests and normal device operation via the presenting electrogram (EGM). This CRT-D remains in service. No additional adverse patient effects were reported.

  Patient problems: Shock from Patient Lead(s)

  MAUDE report 50941692 ↗
• InjurySep 29, 2026Pacing Problem; Inappropriate/Inadequate Shock/Stimulation

  It was reported that this cardiac resynchronization therapy defibrillator (CRT-D) delivered inappropriate anti-tachycardia pacing (ATP) and shocks for atrial fibrillation (AF) with rapid ventricular response (RVR). Technical Services (TS) faxed the reports for the health care professional (HCP) to review. This device remains in service. No additional adverse patient effects were reported.

  Patient problems: Shock from Patient Lead(s)

  MAUDE report 50928092 ↗
• MalfunctionSep 28, 2026High impedance

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50924317 ↗
• InjurySep 28, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that this cardiac resynchronization therapy defibrillator (CRT-D) was part of a system revision due to infection. There were no additional adverse patient effects reported. The CRT-D was explanted.

  Patient problems: Unspecified Infection

  MAUDE report 50919973 ↗
• MalfunctionSep 28, 2026High impedance

  It was reported that this cardiac resynchronization therapy defibrillator (CRT-D) and the non-Boston Scientific right ventricular (RV) lead exhibited a high out of range shock impedance measurement, greater than 200 Ohms. Technical Services (TS) discussed that the measurement was stable in the 40-50 Ohm range until the out of range measurement. There was no evidence of lead noise. TS recommended further in clinic evaluation. This CRT-D remains in service. No adverse patient effects were reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50917569 ↗
• InjurySep 28, 2026Defibrillation/Stimulation Problem

  It was reported that the health care professional (HCP) requested a review of reports for this cardiac resynchronization therapy defibrillator (CRT-D). Technical Services (TS) reviewed the data and determined four anti-tachycardia pacing (ATP) and one shock were delivered to convert the ventricular arrhythmia. The fourth ATP accelerated the arrhythmia, but the shock was able to convert the rhythm. No additional adverse patient effects were reported. This CRT-D remains in service.

  Patient problems: Tachycardia

  MAUDE report 50913955 ↗
• MalfunctionSep 25, 2026Over-Sensing

  It was reported that this cardiac resynchronization therapy defibrillator (CRT-D) delivered inappropriate Atrial Tachy Response (ATR) due to oversensing of ventricular activity on the right atrial (RA) channel. Technical Services (TS) recommended programming enhancements. This device remains in service. No adverse patient effects were reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50899043 ↗
• MalfunctionSep 23, 2026Signal Artifact/Noise; Over-Sensing; Pacing Problem; Failure to Read Input Signal

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50876269 ↗
• MalfunctionSep 23, 2026Pacing Problem; Unexpected Therapeutic Results

  Patient problems: Bradycardia; Malaise

  MAUDE report 50873325 ↗
• InjurySep 17, 2026Device Sensing Problem

  It was reported that the patient with this cardiac resynchronization therapy defibrillator (CRT-D) presented to the emergency room with asystole and transcutaneous pacing for resuscitation. Technical Services (TS) was notified that an emergency device replacement occurred to a competitors device. TS reviewed data and found only four successful left ventricular automatic threshold tests in the previous three months; however, no reason was provided. The device was returned to Boston Scientific for further analysis. No additional adverse patient effects were reported. This CRT-D is no longer in service.

  Patient problems: Asystole

  MAUDE report 50801950 ↗
• InjurySep 17, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that this cardiac resynchronization therapy defibrillator (CRT-D) was part of a system revision due to infection. There were no additional adverse patient effects reported. The CRT-D was explanted.

  Patient problems: Unspecified Infection

  MAUDE report 50797983 ↗
• MalfunctionSep 16, 2026High impedance

  It was reported that this cardiac resynchronization therapy defibrillator (CRT-D) system exhibited high out of range pacing impedance measurements on the left ventricular (LV) lead. It was noted that multisite pacing was off. Technical Services (TS) recommended continued monitoring and did not believe it was impacting device performance because multisite pacing was off. No adverse patient effects were reported. This CRT-D remains in service.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50788141 ↗
• InjurySep 4, 2026Failure to Capture; High Capture Threshold

  It was reported that the patient with this cardiac resynchronization therapy defibrillator (CRT-D) went to the emergency room (ER) due to feeling unwell. Upon review of the presenting electrogram (EGM) it was determine there was intermittent loss of capture (LOC) on the right ventricular (RV) lead. Technical Services (TS) reviewed and confirmed the intermittent LOC and also noted the capture thresholds were steadily rising on the RV lead. Subsequently, this CRT-D was explanted and replaced. No additional adverse patient effects were reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50602112 ↗
• MalfunctionSep 4, 2026Signal Artifact/Noise; Over-Sensing

  It was reported that this cardiac resynchronization therapy defibrillator (CRT-D) system exhibited noise in the right ventricular (RV) channel and oversensed noise which led to inappropriate Atrial Tachy Response (ATR) in the right atrial (RA) channel. Technical Services (TS) was contacted and after reviewing the data, recommended follow up to test the leads. This CRT-D remains in service. No adverse patient effects were reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50602110 ↗
• MalfunctionSep 4, 2026Pacing Problem

  Patient problems: Burning Sensation; Chest Pain

  MAUDE report 50602067 ↗
• MalfunctionSep 4, 2026Over-Sensing

  It was reported that this cardiac resynchronization therapy defibrillator (CRT-D) exhibited isolated oversensing of noisy signals during its implant procedure. Technical Services (TS) reviewed stored data and determined that the noise observed was probably due electromagnetic interference (EMI) from the implant procedure. No other device issues were observed and all measurements were within range. This device remains in service. No adverse patient effects were reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50601439 ↗
• MalfunctionSep 4, 2026Failure to Capture; High Capture Threshold

  It was reported that this cardiac resynchronization therapy defibrillator (CRT-D) exhibited high capture thresholds and loss of capture (LOC) for its left ventricular (LV) lead. Technical Services (TS) was consulted and discussed programming options and settings. This device remains in service. No adverse patient effects were reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50601426 ↗
• InjurySep 4, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that the patient with this cardiac resynchronization therapy defibrillator (CRT-D) had exhibited serosanguinous drainage at the incision site, accompanied by minor swelling; no odor was present. A wound dressing was applied, and prophylactic antibiotic therapy was prescribed. No additional adverse patient effects were reported. This CRT-D remains in service.

  Patient problems: Fluid Discharge; Impaired Healing; Pain; Swelling/ Edema

  MAUDE report 50601344 ↗
• InjurySep 4, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that this cardiac resynchronization therapy defibrillator (CRT-D) was part of a system revision due to infection. There were no additional adverse patient effects reported. This CRT-D was explanted.

  Patient problems: Unspecified Infection

  MAUDE report 50601342 ↗
• InjurySep 2, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Unspecified Infection

  MAUDE report 50567446 ↗
• InjurySep 2, 2026No Apparent Adverse Event

  It was reported that this cardiac resynchronization therapy defibrillator (CRT-D) was part of this part of the system revision due to infection. No adverse patient effects were reported. The CRT-D was explanted.

  Patient problems: Unspecified Infection

  MAUDE report 50566054 ↗
• InjuryAug 25, 2026Pacing Problem; Inappropriate/Inadequate Shock/Stimulation

  It was reported that this cardiac resynchronization therapy defibrillator (CRT-D) delivered two shocks and four rounds of anti-tachycardia pacing (ATP) for what appeared to be atrial fibrillation (AF) with rapid ventricular response (RVR). Technical Services (TS) was contacted and after reviewing the data, recommended possible reprogramming options. This CRT-D remains in service. No additional adverse patient effects were reported.

  Patient problems: Shock from Patient Lead(s)

  MAUDE report 50424464 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under P010012. One submission often covers many models, so check the product and lot details in each record.

• Z-1671-2022 · Jul 7, 2022 · Open, Classified
  The PRM is intended to be used as part of the ZOOM LATITUDE Programming System to communicate with Boston Scientific implantable pulse generators. The software in use controls all
• Z-0080-2018 · Oct 4, 2017 · Terminated
  MOMENTUM X4 CRT-D, Model G138, Sterile.
• Z-0079-2018 · Oct 4, 2017 · Terminated
  VIGILANT X4 CRT-D, Model G247, Sterile. Cardiac Resynchronization Therapy Defibrillators (CRT-Ds) are indicated for patients with heart failure who receive stable optimal pharma
• Z-0081-2018 · Oct 4, 2017 · Terminated
  RESONATE X4 CRT-D, Model G447, Sterile.
• Z-1556-2010 · Mar 15, 2010 · Terminated
  Boston Scientific LIVIAN Cardiac Resynchronization Therapy Defibrillator (CRT-D), models H220, H225, H227, H229. The LIVIAN family of cardiac resynchronization therapy defibrillat
• Z-0609-2010 · Dec 1, 2009 · Terminated
  Boston Scientific COGNIS CRT-D, Cardiac Resynchronization Therapy Defibrillator, models N118, N119. the following models are not available in the US: models N106, N107, P106, P107,
• Z-1054-2007 · Mar 23, 2007 · Terminated
  VITALITY DR HE Implantable Cardioverter Defibrillator (model T180). Sterile EO. Guidant Corporation, Cardiac Rhythm Management, 4100 Hamline Avenue North, St. Paul, MN 55112-5798 U
• Z-1047-2007 · Mar 23, 2007 · Terminated
  CONTAK RENEWAL 3 (model H170, H175) CONTAK RENEWAL 3 HE (model H177, H179) Cardiac Resynchronization Therapy Defibrillator (CRT-D). Guidant Corporation, 4100 Hamline Avenue North,
• Z-1049-2007 · Mar 23, 2007 · Terminated
  CONTAK RENEWAL 3 RF (model H210, H215), CONTAK RENEWAL 3 RF HE (model H217, H219) cardiac resynchronization therapy defibrillator (CRT-D).
• Z-1053-2007 · Mar 23, 2007 · Terminated
  VITALITY 2 (model T165, T175), VITALITY DS (model T125, T135), VITALITY EL (model T127), Implantable Cardioverter Defibrillators (ICD), are designed to detect and terminate ventric
• Z-1052-2007 · Mar 23, 2007 · Terminated
  VITALITY AVT (model A155). Implantable Cardioverter Defibrillator. Atrial and Ventricular Therapies. Guidant Corporation Cardiac Rhythm Management, 4100 Hamline Avenue North, St. P
• Z-1055-2007 · Mar 23, 2007 · Terminated
  VITALITY 2 EL DR/VR (model T167, T177). contents have been sterilized with gaseous ethylene oxide. The Guidant Vitality 2 ICD, implantable cardioverter defibrillators, are design
• Z-0047-2008 · Mar 16, 2007 · Terminated
  Guidant VITALITY VR/DR, Implantable Cardioverter Defibrillator, ICD, Models 1870 and 1871. Guidant VITALITY DR+, Implantable Cardioverter Defibrillator, ICD, Model 1872.
• Z-1288-06 · May 15, 2006 · Terminated
  Guidant CONTAK RENEWAL 3 (models H170, H175) CONTAK RENEWAL 3 HE (models H177, H179) Cardiac Resynchronization Therapy Defibrillator (CRT-D). Guidant Corporation, 4100 Hamline Ave
• Z-0826-06 · Apr 7, 2006 · Terminated
  Guidant CONTAK RENEWAL 4 (models H190, H195) CONTAK RENEWAL; 4 HE (model H197). Cardiac Resynchronization Therapy Defibrillator (CRT-D). Sterile EO. Guidant Corporation, 4100 Ha

…and 4 more.