VISIONIST™ CRT-P U225Recalls & reported problems

Summary

The FDA's MAUDE database contains 253 adverse event reports that list this exact device (DI 00802526559426), received between Oct 25, 2018 and Sep 25, 2026 — classified as 2 deaths, 121 injuries, 130 malfunctions.

The most frequently reported specific device problem is “Premature Discharge of Battery” (69 reports).

1 FDA recall record name this device's identifier, 1 still open.

19 other recalls cover devices cleared under the same FDA submission (P030005); 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 16, 2026.

Recalls naming this device

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

Most reported problems

Recent adverse event reports

The 25 most recent of 253 reports, 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 ↗
• MalfunctionAug 6, 2026Over-Sensing

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50162193 ↗
• MalfunctionAug 3, 2026Premature Discharge of Battery

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50119795 ↗
• MalfunctionJul 30, 2026Signal Artifact/Noise; Premature Discharge of Battery; Use of Device Problem; Data Problem; Interrogation Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50091214 ↗
• MalfunctionJul 21, 2026Premature Discharge of Battery; Battery Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25892721 ↗
• MalfunctionJul 9, 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. A REQUEST WAS MADE TO HAVE DATA FROM THIS DEVICE ANALYZED. 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 25767040 ↗
• MalfunctionJun 29, 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. A REQUEST WAS MADE TO HAVE DATA FROM THIS DEVICE ANALYZED. DATA ANALYSIS IDENTIFIED POTENTIAL HIGH IMPEDANCE WITHIN THE BATTERY. CONTINUED MONITORING WAS RECOMMENDED. NO ADVERSE PATIENT EFFECTS WERE REPORTED. THIS DEVICE REMAINS IN SERVICE AT THIS TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25659513 ↗
• InjuryJun 26, 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 WAS NO ADDITIONAL ADVERSE PATIENT EFFECTS REPORTED. THIS CRT-P WAS EXPLANTED.

  Patient problems: Unspecified Infection

  MAUDE report 25638457 ↗
• MalfunctionJun 17, 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. THIS DEVICE REMAINS IN USE. NO ADVERSE PATIENT EFFECTS WERE REPORTED. ADDITIONAL INFORMATION RECEIVED INDICATES THAT THE PATIENT WILL CONTINUED TO BE MONITORED. THE DEVICE REMAINS IN USE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25538441 ↗
• MalfunctionJun 16, 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. A REQUEST WAS MADE TO HAVE DATA FROM THIS DEVICE ANALYZED. 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 25523841 ↗
• MalfunctionJun 10, 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. A REQUEST WAS MADE TO HAVE DATA FROM THIS DEVICE ANALYZED. 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 25463960 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under P030005. One submission often covers many models, so check the product and lot details in each record.

• Z-1771-2026 · Mar 19, 2026 · Open, Classified
  Boston Scientific Cardiac Resynchronization Therapy (CRT)labeled as: 1. VALITUDE CRT-P EL, Model Number U125; 2. VALITUDE CRT-P EL MRI, Model Number U128; 3. VISIONIST CRT-P EL
• Z-0101-2026 · Aug 20, 2025 · Open, Classified
  Model Number U125, VALITUDE CRT-P EL
• Z-0104-2026 · Aug 20, 2025 · Open, Classified
  Model Number U226, VISIONIST CRT-P EL
• Z-0105-2026 · Aug 20, 2025 · Open, Classified
  Model Number U228, VISIONIST CRT-P EL MRI
• Z-0102-2026 · Aug 20, 2025 · Open, Classified
  Model Number U128, VALITUDE CRT-P EL MRI
• Z-0826-2025 · Dec 12, 2024 · Open, Classified
  VALITUDE CRT-P, EL (Model Number U125) and EL MRI (Model Number U128)
• Z-0827-2025 · Dec 12, 2024 · Open, Classified
  VISIONIST CRT-P, EL (Model Number U225 and U226) and EL MRI (Model Number U228)
• Z-2002-2021 · Jun 3, 2021 · Open, Classified
  VALITUDE CRT-P pacemaker, Models: a) U125 b) U128
• Z-2018-2021 · Jun 3, 2021 · Open, Classified
  INVIVE CRT-P, Model Numbers: a) V172 b) V173 c) V182 d) V183 e) W172 f) W173
• Z-2019-2021 · Jun 3, 2021 · Open, Classified
  INTUA CRT-P, Model Numbers: a) V272 b) V273 c) W273
• Z-2020-2021 · Jun 3, 2021 · Open, Classified
  INLIVEN CRT-P, Model Numbers: a) V284 b) V285 c) W274 d) W275 (added 7/15/2021)
• Z-2003-2021 · Jun 3, 2021 · Open, Classified
  VISIONIST CRT-P pacemaker, Models: a) U225 b) U226 c) U228
• Z-3258-2018 · Sep 10, 2018 · Terminated
  VALITUDE X4 CRT-P (Cardiac Resynchronization Therapy Pacemaker)
• Z-3259-2018 · Sep 10, 2018 · Terminated
  VISIONIST X4 CRT-P (Cardiac Resynchronization Therapy Pacemaker)
• Z-0360-2018 · Dec 7, 2017 · Open, Classified
  VALITUDE CRT-P Pacemaker

…and 4 more.