VISIONIST CRT-PRecalls & reported problems across all models

We found 2 models of VISIONIST CRT-P by Boston Scientific Corporation in the FDA's device registry (GUDID). Together they are named in 271 adverse event reports in the FDA's MAUDE database, received between Oct 10, 2017 and Sep 25, 2026 — classified as 2 deaths, 129 injuries, 140 malfunctions.

The most frequently reported specific device problem is “Premature Discharge of Battery” (72 reports).

3 FDA recall records name at least one of these models by its device identifier, 3 still open.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

VISIONIST CRT-P recalls

FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.

1. Aug 20, 2025Open, Classified

   Software to enhance Safety Architecture is available and designed to prevent initiation of Safety Mode in an ambulatory setting due to a high battery impedance state for the ACCOLADE family of devices which includes ACCOLADE, PROPONENT, ESSENTIO, and ALTRUA 2 dual chamber (DR) standard life (SL) and DR extended life (EL) pacemakers; and VISIONIST and VALITUDE cardiac resynchronization therapy pacemakers (CRT-Ps).

   Z-0104-2026 · Root cause: Other · Recall details · FDA record ↗

2. Aug 20, 2025Open, Classified

   Software to enhance Safety Architecture is available and designed to prevent initiation of Safety Mode in an ambulatory setting due to a high battery impedance state for the ACCOLADE family of devices which includes ACCOLADE, PROPONENT, ESSENTIO, and ALTRUA 2 dual chamber (DR) standard life (SL) and DR extended life (EL) pacemakers; and VISIONIST and VALITUDE cardiac resynchronization therapy pacemakers (CRT-Ps).

   Z-0103-2026 · Root cause: Other · Recall details · FDA record ↗

3. Dec 12, 2024Open, Classified

   A subset of devices from the ACCOLADE Family of Pacemakers and CRT-Ps, built before September 2018, have an increased potential to initiate Safety Mode during telemetry or other normal, higher-power operations due to latent high battery impedance.

   Z-0827-2025 · Root cause: Process design · Recall details · FDA record ↗

Most reported VISIONIST CRT-P problems

VISIONIST CRT-P models

2 models, most reported first. Each model has its own page with its reports, recalls and device details.

• VISIONIST™ CRT-P U225

  Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)
  1 recall2 deaths253 reports
• VISIONIST™ CRT-P U226

  Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)
  2 recalls18 reports

Recent VISIONIST CRT-P adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

• MalfunctionSep 25, 2026Failure to Capture; Pacing Problem

  t was reported that this cardiac resynchronization therapy pacemaker (CRT-P) and the left ventricular (LV) lead suspended a left ventricular automatic threshold (LVAT) test. Technical Services (TS) reviewed device data and confirmed the LVAT was suspended due to fusion beats. Also, the presenting electrogram (EGM) exhibited loss of capture on the LV lead due to the LV and right ventricular (RV) beats falling on top of each other. TS recommended further evaluation in clinic. This CRT-P remains in service. No adverse patient effects were reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50899270 ↗
• InjurySep 25, 2026Adverse Event Without Identified Device or Use Problem

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

  Patient problems: Unspecified Infection

  MAUDE report 50896912 ↗
• InjurySep 15, 2026Pacing Problem

  It was reported that this cardiac resynchronization therapy pacemaker (CRT-P) recorded pacemaker mediated tachycardia (PMT) episode stored in the configured collection period. The Boston Scientific Technical Services consultant discussed that the PMT episodes appeared atrial or sinus driven and presenting electrogram showed that the device was operating as programmed. As of this time, this CRT-P remains in service. No adverse patient effects were reported.Additional information indicated that this CRT-P was explanted and replaced with a different model. No additional adverse patient effects were reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50772778 ↗
• MalfunctionSep 14, 2026Pacing Problem; Under-Sensing

  It was reported that this cardiac resynchronization therapy pacemaker (CRT-P) exhibited undersensing and a decrease in biventricular pacing. Technical Services (TS) was consulted and confirmed the undersensing was through the non-Boston Scientific atrial lead. TS informed the health care professional that this allows intrinsic beats to occur and prevents the biventricular pacing. TS reviewed measurements and recommended programming atrial sensitivity to a nominal value. No adverse patient effects were reported. This CRT-P remains in service.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50754468 ↗
• MalfunctionSep 11, 2026Premature Discharge of Battery

  It was reported that this cardiac resynchronization therapy pacemaker (CRT-P) recorded a Code 1003, indicating the voltage was too low for the projected remaining capacity. A request was made to have data from this device analyzed. Data analysis identified potential high impedance within the battery. Continued monitoring was recommended. The device remains in service. No adverse patient effects were reported.Additional information was received indication that the device firmware was successfully updated during a clinic follow-up, and the patient will continue to be monitored by the clinic. No adverse patient effects were reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50725356 ↗
• MalfunctionSep 7, 2026Premature Discharge of Battery

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50656112 ↗
• InjurySep 7, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Unspecified Infection

  MAUDE report 50652581 ↗
• MalfunctionSep 4, 2026Premature Discharge of Battery

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50602436 ↗
• MalfunctionSep 4, 2026Premature Discharge of Battery

  It was reported that this cardiac resynchronization therapy pacemaker (CRT-P) recorded a Code 1003, indicating the voltage is too low for the projected remaining capacity. Data analysis identified potential high impedance within the battery. Continued monitoring was recommended. This device remains in service. No adverse patient effects were reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50602341 ↗
• MalfunctionSep 4, 2026Signal Artifact/Noise; Over-Sensing

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50602158 ↗
• InjurySep 4, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that the patient with this cardiac resynchronization therapy pacemaker (CRT-P) experienced impaired healing of pocket site. Reportedly, the site was unable to heal since implant. According to the physician, the patient agrees that the pocket site never really healed. Ultimately, the patient's dog jumped on the chest and ripped the site open. There were no additional adverse patient effects reported. The CRT-P was explanted.

  Patient problems: Impaired Healing; Pocket Erosion

  MAUDE report 50601112 ↗
• MalfunctionSep 4, 2026Premature Discharge of Battery

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50600881 ↗
• MalfunctionAug 7, 2026Premature Discharge of Battery

  It was reported that this device recorded a Code 1003, indicating the voltage is too low for the projected remaining capacity. A request was made to have data from this device analyzed. Data analysis identified potential high impedance within the battery. Continued monitoring was recommended. The device still remains in service. No adverse patient effects were reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50181869 ↗
• InjuryAug 7, 2026Premature Discharge of Battery

  It was reported that this cardiac resynchronization therapy pacemaker (CRT-P) recorded a fault code 1003 indicative of a battery voltage too low for the projected remaining capacity. Subsequently, this CRT-P was explanted and replaced. This device was received for investigation. No additional adverse patient effects were reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50168830 ↗
• MalfunctionAug 6, 2026Premature Discharge of Battery

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50165157 ↗

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