VALITUDE™ CRT-P U125Recalls & reported problems

Summary

The FDA's MAUDE database contains 558 adverse event reports that list this exact device (DI 00802526559389), received between Apr 25, 2016 and Sep 29, 2026 — classified as 2 deaths, 306 injuries, 250 malfunctions.

The most frequently reported specific device problem is “Premature Discharge of Battery” (135 reports).

2 FDA recall records name this device's identifier, 2 still open.

18 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 18, 2026.

Recalls naming this device

1. Aug 20, 2025Class IOpen, 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-0101-2026 · Root cause: Other · Recall details · FDA record ↗

2. Dec 12, 2024Class IOpen, 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-0826-2025 · Root cause: Process design · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 558 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 29, 2026Premature Discharge of Battery

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50941407 ↗
• MalfunctionSep 28, 2026Premature Discharge of Battery

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50918059 ↗
• MalfunctionSep 28, 2026Use of Device Problem; Interrogation Problem

  It was reported that the communicator of this cardiac resynchronization therapy pacemaker (CRT-P) displayed a yellow collecting wave. Technical Services (TS) recommended working with the clinic to verify the radio frequency (RF) settings in the device. It was noted the patient was seen in the clinic approximately one week later and a patient-initiated interrogation (PII) was attempted, and the yellow collecting wave was still present. While in the clinic, it was determined that RF had been disabled. It was suspected the patient likely got the newest software update when they were seen in the clinic approximately four months ago, and RF disabled with the first measurement taken by the new algorithm, which is why there was no alert. It was noted the patient would be scheduled for a device change out. No adverse patient effects were reported. This CRT-P remains in service.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50914865 ↗
• MalfunctionSep 25, 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 50898079 ↗
• InjurySep 20, 2026Premature Discharge of Battery

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50834818 ↗
• MalfunctionSep 16, 2026Premature Discharge of Battery

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50796760 ↗
• MalfunctionSep 14, 2026Premature Discharge of Battery

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50756128 ↗
• InjurySep 8, 2026Premature Discharge of Battery

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50678897 ↗
• MalfunctionSep 7, 2026Premature Discharge of Battery

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50652338 ↗
• MalfunctionSep 7, 2026Premature Discharge of Battery

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50650186 ↗
• MalfunctionSep 4, 2026Incorrect, Inadequate or Imprecise Result or Readings

  It was reported that this pacemaker reverted to Safety Mode. Technical Services (TS) was contacted and after reviewing the data, device replacement was recommended. This pacemaker remains in service. No adverse patient effects were reported. Additional information was received indicating that this device was explanted and replaced. No additional adverse patient effects were reported. This device has been returned for analysis.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50602350 ↗
• MalfunctionSep 4, 2026Premature Discharge of Battery; Data Problem

  It was reported that this device recorded a Code 1003, indicating the voltage was too low for the projected remaining capacity. Additionally, no data was available. Technical Services (TS) was consulted and stated that data will need to be transmitted from home or through an in office check. 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 will remain implanted, and the patient will be monitored at this time. No adverse patient effects were reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50602276 ↗
• InjuryAug 30, 2026Signal Artifact/Noise; Failure to Capture

  Patient problems: Unspecified Infection

  MAUDE report 50510331 ↗
• InjuryAug 24, 2026Extracardiac stimulation; Incorrect, Inadequate or Imprecise Result or Readings; Battery Problem

  It was reported that this cardiac resynchronization therapy pacemaker (CRT-P) reverted to Safety Mode. When attempting a software update, the device went from ten months remaining to seven months remaining then reverted to Safety Mode. "0xa" and "Oscillator mismatch" codes were also recorded. The patient stated they felt uncomfortable and experienced stimulation while in office. Technical Services (TS) recommended device replacement. This CRT-P was explanted, replaced, and returned for analysis. No additional adverse patient effects were reported.

  Patient problems: Device Overstimulation of Tissue; Discomfort

  MAUDE report 50419152 ↗
• MalfunctionAug 24, 2026Use of Device Problem; Interrogation Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50416021 ↗
• MalfunctionAug 19, 2026Premature Discharge of Battery; Battery Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50331330 ↗
• InjuryAug 14, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that the patient developed an infection of the cardiac resynchronization therapy pacemaker (CRT-P) system and underwent an explant procedure of all components on (b)(6) 2026. The procedure started with extraction of the lead that was placed for left bundle branch area pacing. Minimal laser was required and the lead was successfully removed. Next, the atrial lead was extracted and during removal a loss of capture occurred on the temporary right ventricular (RV) pacing lead due to the lead catheter being pulled on. The patient was noted to be dependent, with no underlying rhythm. The healthcare provider (HCP) moved to adjust the temporary pacing device and inadvertently caught his foot on the laser equipment and pulled on the atrial lead, dislodging it from the heart. At the same time another HCP was able to increase the output on the temporary device. After the atrial lead was extracted the patient's blood pressure began to drop when capture was lost. Medication was administered and the patient underwent a transesophageal echocardiogram (TEE) to examine the heart and no issues were observed.Once the patient's BP was stabilized, and capture with the temporary RV lead

  Patient problems: Unspecified Infection

  MAUDE report 50248282 ↗
• MalfunctionAug 7, 2026Premature Discharge of Battery

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50176692 ↗
• InjuryAug 5, 2026Premature Discharge of Battery; Use of Device Problem; Interrogation Problem

  It was reported that this pacemaker disabled radio frequency (RF) telemetry due a single low battery voltage measurement. A request was made to have data from this device analyzed. Data analysis identified potential high impedance within the battery. Additional information received reported that this pacemaker was explanted and replaced. No additional adverse patient effects were reported. Product return was requested.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50137458 ↗
• MalfunctionAug 3, 2026Premature Discharge of Battery

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50117794 ↗
• MalfunctionJul 29, 2026Premature Discharge of Battery

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50071245 ↗
• MalfunctionJul 28, 2026Premature Discharge of Battery

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50057737 ↗
• MalfunctionJul 28, 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. Additional information was received indicating that this device was explanted and replaced. No additional adverse patient effects were reported, and this device has not been returned.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50057736 ↗
• InjuryJul 27, 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. This CRT-P was explanted.

  Patient problems: Unspecified Infection

  MAUDE report 50018626 ↗
• MalfunctionJul 27, 2026Premature Discharge of Battery

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50008624 ↗

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-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-0104-2026 · Aug 20, 2025 · Open, Classified
  Model Number U226, VISIONIST CRT-P EL
• Z-0103-2026 · Aug 20, 2025 · Open, Classified
  Model Number U225 VISIONIST CRT-P EL
• Z-0827-2025 · Dec 12, 2024 · Open, Classified
  VISIONIST CRT-P, EL (Model Number U225 and U226) and EL MRI (Model Number U228)
• Z-2003-2021 · Jun 3, 2021 · Open, Classified
  VISIONIST CRT-P pacemaker, Models: a) U225 b) U226 c) U228
• Z-2019-2021 · Jun 3, 2021 · Open, Classified
  INTUA CRT-P, Model Numbers: a) V272 b) V273 c) W273
• 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-2002-2021 · Jun 3, 2021 · Open, Classified
  VALITUDE CRT-P pacemaker, Models: a) U125 b) U128
• 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-3259-2018 · Sep 10, 2018 · Terminated
  VISIONIST X4 CRT-P (Cardiac Resynchronization Therapy Pacemaker)
• Z-3258-2018 · Sep 10, 2018 · Terminated
  VALITUDE X4 CRT-P (Cardiac Resynchronization Therapy Pacemaker)
• Z-0366-2018 · Dec 7, 2017 · Open, Classified
  VISIONIST X4 CRT-P Pacemaker
• Z-0361-2018 · Dec 7, 2017 · Open, Classified
  VALITUDE X4 CRT-P Pacemaker

…and 3 more.