VALITUDE™ X4 CRT-P U128Recalls & reported problems

Summary

The FDA's MAUDE database contains 2,073 adverse event reports that list this exact device (DI 00802526559402), received between Apr 21, 2016 and Sep 30, 2026 — classified as 26 deaths, 1,231 injuries, 816 malfunctions.

The most frequently reported specific device problem is “Premature Discharge of Battery” (540 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-0102-2026 · 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 2,073 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 30, 2026Premature Discharge of Battery

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50948857 ↗
• MalfunctionSep 30, 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 50947938 ↗
• InjurySep 29, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Unspecified Infection

  MAUDE report 50941281 ↗
• InjurySep 29, 2026Incorrect, Inadequate or Imprecise Result or Readings

  Patient problems: Dizziness; Dyspnea

  MAUDE report 50938864 ↗
• MalfunctionSep 29, 2026Premature Discharge of Battery

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50938655 ↗
• MalfunctionSep 29, 2026Premature Discharge of Battery

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50935758 ↗
• InjurySep 29, 2026Over-Sensing; Pacing Problem

  It was reported that this cardiac resynchronization therapy pacemaker (CRT-P) was explanted due to unknown reasons. No additional adverse patient effects were reported. This CRT-P was returned for analysis.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50934462 ↗
• InjurySep 29, 2026Incorrect, Inadequate or Imprecise Result or Readings

  It was reported that the patient with this cardiac resynchronization therapy pacemaker (CRT-P) presented to the emergency room (ER) due to chest stimulation. In addition discomfort and pain were mentioned. Device was interrogated and was found to be in safety mode. Subsequently the patient was transfer to another facility were the device was explanted and replaced. The device has not been returned for analysis. No additional adverse patient effects were reported.

  Patient problems: Device Overstimulation of Tissue; Discomfort; Pain

  MAUDE report 50933188 ↗
• InjurySep 29, 2026Premature Discharge of Battery

  It was reported that this cardiac resynchronization therapy pacemaker (CRT-P) recorded a Code 1003, which states that the voltage is too low for projected remaining capacity. Subsequently, this device was explanted and replaced. This product has not been returned for analysis. No additional adverse patient effects were reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50928530 ↗
• MalfunctionSep 28, 2026Use of Device Problem; Interrogation Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50926077 ↗
• MalfunctionSep 28, 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 50920999 ↗
• MalfunctionSep 28, 2026Premature Discharge of Battery

  It was reported that this cardiac resynchronization therapy pacemaker (CRT-P) recorded a Code 1003, which states that the voltage is too low for projected remaining capacity. It was reported that a request was made to have data from this device analyzed. Data analysis identified potential high impedance within the battery. Device replacement was recommended. This device remains in service. No adverse patient effects were reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50920294 ↗
• MalfunctionSep 28, 2026Premature Discharge of Battery; Data Problem

  It was reported that this device was unable to upload data. Additionally, a Code 1003 was noted. Technical Services (TS) was consulted and determined that the Code occurred last November, with radio frequency (RF) telemtry being disabled in April. due to the patient being dependent, a device replacement procedure has been scheduled. No adverse patient effects were reported. This device remains in service.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50915239 ↗
• MalfunctionSep 25, 2026Signal Artifact/Noise; Over-Sensing

  It was reported that this cardiac resynchronization therapy pacemaker (CRT-P) had a false Signal Artifact Monitor (SAM) event due to electrocautery. Noise was noted on the leads for this device. Technical Services (TS) recommended bringing the patient into the clinic to reprogram the device. This CRT-P remains in service. No adverse patient effects were reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50899536 ↗
• InjurySep 25, 2026Incorrect, Inadequate or Imprecise Result or Readings

  It was reported that this cardiac resynchronization therapy pacemaker (CRT-P) was found to be in Safety Mode. Subsequently, this device was explanted and replaced. This CRT-P has not been received for investigation. No additional adverse patient effects were reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50899534 ↗
• InjurySep 25, 2026Nonstandard Device; Insufficient Device Problem Information

  It was reported that upon completion of the product analysis, this device was confirmed to have been operating in Safety Mode. The device was confirmed to be able to perform a memory dump, and it never triggered the Elective Replacement Indicator. No additional adverse patient effects were reported. This device is no longer in service.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50899310 ↗
• 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 50893883 ↗
• MalfunctionSep 25, 2026Premature Discharge of Battery

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50892560 ↗
• MalfunctionSep 24, 2026Premature Discharge of Battery

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50889708 ↗
• InjurySep 24, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that this cardiac resynchronization therapy pacemaker (CRT-P) system exhibited infection. Subsequently, the device and leads were explanted. No additional adverse patient effects were reported.

  Patient problems: Unspecified Infection

  MAUDE report 50889244 ↗
• MalfunctionSep 24, 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 50884999 ↗
• MalfunctionSep 24, 2026Over-Sensing

  It was reported that a request was made to have data from this cardiac resynchronization therapy pacemaker (CRT-P) analyzed. Technical Services (TS) reviewed the data and identified farfield oversensing on the presenting electrogram (EGM). This device remains in service. No adverse patient effects were reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50884189 ↗
• MalfunctionSep 23, 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 50869414 ↗
• MalfunctionSep 18, 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 50817810 ↗
• MalfunctionSep 18, 2026Premature Discharge of Battery; Use of Device Problem; Interrogation Problem

  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. Additionally, remote monitoring was disabled. A request was made to have data from this device analyzed. Data analysis identified potential high impedance within the battery. Device replacement was recommended. This device remains in service. No adverse patient effects were reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50813072 ↗

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-0103-2026 · Aug 20, 2025 · Open, Classified
  Model Number U225 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-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-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-2019-2021 · Jun 3, 2021 · Open, Classified
  INTUA CRT-P, Model Numbers: a) V272 b) V273 c) W273
• Z-2003-2021 · Jun 3, 2021 · Open, Classified
  VISIONIST CRT-P pacemaker, Models: a) U225 b) U226 c) U228
• 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-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-0361-2018 · Dec 7, 2017 · Open, Classified
  VALITUDE X4 CRT-P Pacemaker
• Z-0365-2018 · Dec 7, 2017 · Open, Classified
  VISIONIST CRT-P Pacemaker

…and 3 more.