VISIONIST™ X4 CRT-P U228Recalls & reported problems

Summary

The FDA's MAUDE database contains 819 adverse event reports that list this exact device (DI 00802526559471), received between Jan 24, 2019 and Sep 28, 2026 — classified as 4 deaths, 413 injuries, 402 malfunctions.

The most frequently reported specific device problem is “Premature Discharge of Battery” (161 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 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-0105-2026 · Root cause: Other · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 819 reports, in the reporter's own words as published by the FDA.

• 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. This device remains in service. No adverse patient effects were reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50917670 ↗
• InjurySep 28, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Unspecified Infection

  MAUDE report 50917021 ↗
• MalfunctionSep 28, 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 until radio frequency (RF) disabled, after which time device replacement was recommended. The device remains in services. No adverse patient effects were reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50915237 ↗
• MalfunctionSep 28, 2026Premature Discharge of Battery

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50914860 ↗
• InjurySep 26, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Unspecified Infection

  MAUDE report 50907233 ↗
• MalfunctionSep 24, 2026Premature Discharge of Battery

  It was reported that this pacemaker 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 50884943 ↗
• MalfunctionSep 23, 2026Use of Device Problem; Interrogation Problem

  It was reported that this cardiac resynchronization therapy pacemaker (CRT-P) exhibited a Remote Monitoring Disabled (RMD) alert. Engineering analysis determined that the alert was very likely a false positive radio frequency (RF) disablement caused by magnet application during a loaded battery voltage measurement rather than an actual battery-related condition. Review of prior device data demonstrated normal loaded battery voltage measurements. A software update was recommended to restore telemetry functionality. No adverse patient effects were reported. This CRT-P remains in service.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50869328 ↗
• MalfunctionSep 18, 2026Premature Discharge of Battery

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50831014 ↗
• InjurySep 18, 2026Premature Discharge of Battery

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50828982 ↗
• InjurySep 15, 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. The CRT-P was explanted.

  Patient problems: Unspecified Infection

  MAUDE report 50777189 ↗
• MalfunctionSep 11, 2026Premature Discharge of Battery

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50741460 ↗
• MalfunctionSep 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 50722579 ↗
• MalfunctionSep 8, 2026Premature Discharge of Battery

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50674129 ↗
• InjurySep 7, 2026Signal Artifact/Noise; Over-Sensing; Pacing Problem

  Patient problems: Asystole; Syncope/Fainting

  MAUDE report 50658147 ↗
• MalfunctionSep 7, 2026Premature Discharge of Battery

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50651631 ↗
• MalfunctionSep 7, 2026Premature Discharge of Battery

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50650664 ↗
• MalfunctionSep 6, 2026Premature Discharge of Battery

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50639950 ↗
• MalfunctionSep 4, 2026Premature Discharge of Battery

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50602445 ↗
• MalfunctionSep 4, 2026Premature Discharge of Battery

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50602408 ↗
• MalfunctionSep 4, 2026Premature Discharge of Battery

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50602361 ↗
• MalfunctionSep 4, 2026Premature Discharge of Battery

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50602295 ↗
• InjurySep 4, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Implant Pain

  MAUDE report 50600120 ↗
• InjurySep 3, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Unspecified Infection

  MAUDE report 50594208 ↗
• MalfunctionAug 24, 2026Failure to Capture; Low impedance; High Capture Threshold; Interrogation Problem

  Patient problems: Device Overstimulation of Tissue; Discomfort; No Clinical Signs, Symptoms or Conditions

  MAUDE report 50416002 ↗
• MalfunctionAug 20, 2026Insufficient Device Problem Information

  Patient problems: Irregular Pulse

  MAUDE report 50351084 ↗

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-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-0101-2026 · Aug 20, 2025 · Open, Classified
  Model Number U125, VALITUDE 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-0826-2025 · Dec 12, 2024 · Open, Classified
  VALITUDE CRT-P, EL (Model Number U125) and EL MRI (Model Number U128)
• 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-2003-2021 · Jun 3, 2021 · Open, Classified
  VISIONIST CRT-P pacemaker, Models: a) U225 b) U226 c) U228
• 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-2002-2021 · Jun 3, 2021 · Open, Classified
  VALITUDE CRT-P pacemaker, Models: a) U125 b) U128
• 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

…and 4 more.