VISIONIST™ CRT-P U226Recalls & reported problems

Summary

The FDA's MAUDE database contains 18 adverse event reports that list this exact device (DI 00802526559457), received between Oct 10, 2017 and Jun 11, 2026 — classified as 8 injuries, 10 malfunctions.

The most frequently reported specific device problem is “High impedance” (3 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-0104-2026 · 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-0827-2025 · Root cause: Process design · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 18 most recent of 18 reports, in the reporter's own words as published by the FDA.

• InjuryJun 11, 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. A REQUEST WAS MADE TO HAVE DATA FROM THIS DEVICE ANALYZED. DATA ANALYSIS IDENTIFIED POTENTIAL HIGH IMPEDANCE WITHIN THE BATTERY. IN ADDITION, REMOTE MONITORING WAS DISABLE. DEVICE REPLACEMENT 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 25479952 ↗
• InjuryApr 27, 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 INDICATIVE OF BATTERY VOLTAGE TOO LOW FOR PROJECTED REMAINING CAPACITY, PRIOR TO A PLANNED PROCEDURE. TECHNICAL SERVICES (TS) REVIEWED THE AVAILABLE DATA AND REQUESTED FURTHER DATA SUBMISSION FOR ANALYSIS. SUBSEQUENT EVALUATION CONFIRMED THE DEVICE HAD TRIGGERED A REMOTE MONITORING DISABLEMENT DUE TO LOW BATTERY MEASUREMENT. THE DEVICE WAS UPDATED WITH THE LATEST SOFTWARE; HOWEVER, GIVEN THE BATTERY STATUS AND ADVISORY CONDITIONS, REPLACEMENT WAS RECOMMENDED. NO ADVERSE PATIENT EFFECT WERE REPORTED. THIS CRT-P REMAINS IN SERVICE. ADDITIONAL INFORMATION WAS RECEIVED THAT THIS CRT-P WAS SUCCESSFULLY EXPLANTED AND REPLACED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED OUTSIDE THE REVISION PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25002444 ↗
• MalfunctionApr 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 24969059 ↗
• InjuryMay 21, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT THIS PACEMAKER WAS FOUND TO BE IN SAFETY MODE. THE PATIENT REPORTED EXPERIENCING PALPITATIONS. TECHNICAL SERVICES (TS) WAS CONSULTED AND RECOMMENDED DEVICE REPLACEMENT. THE DEVICE WAS SUBSEQUENTLY EXPLANTED AND REPLACED. THIS PRODUCT HAS NOT BEEN RETURNED FOR ANALYSIS. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Unspecified Heart Problem

  MAUDE report 22064678 ↗
• MalfunctionOct 28, 2024Signal Artifact/Noise; Over-Sensing; Pacing Problem; Signal Artifact/Noise; Over-Sensing; Pacing Problem

  IT WAS REPORTED THAT THE MINUTE VENTILATION (MV) SENSOR OF THIS PACEMAKER WAS DISABLED. REVIEW OF TWO SIGNAL ARTIFACT MONITOR (SAM) EPISODES SHOWED NOISE CONSISTENT WITH ELECTROMAGNETIC INTERFERENCE (EMI). IMPEDANCE MEASUREMENTS WERE APPROPRIATE BOTH BEFORE AND AFTER THE SAM EPISODES. THERE WAS NO PACING INHIBITION AS A RESULT OF THE NOISE. TECHNICAL SERVICES DISCUSSED BRINGING THE PATIENT BACK INTO CLINIC AS NECESSARY TO PROGRAM MV BACK ON. FURTHER INFORMATION WAS RECEIVED THAT THIS PACEMAKER EXHIBITED OVERSENSING OF NOISE ON THE RIGHT ATRIAL (RA) LEAD RESULTING IN PACING INHIBITION AND INAPPROPRIATE ATRIAL TACHY RESPONSE (ATR) EPISODES. NOISE ON THE RIGHT VENTRICULAR (RV) LEAD WAS NOTED. THE INVOLVED RA AND RV LEADS ARE NON BOSTON SCIENTIFIC PRODUCTS. ADDITIONALLY, OVERSENSING ON THE LEFT VENTRICULAR (LV) LEAD WAS SUSPECTED. NO ADVERSE PATIENT EFFECTS WERE REPORTED. THIS DEVICE REMAINS IN SERVICE.

  Patient problems: Bradycardia

  MAUDE report 20546961 ↗
• InjuryOct 3, 2024Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT DURING A CLINIC VISIT, THIS CARDIAC RESYNCHRONIZATION THERAPY PACEMAKER (CRT-P) WAS FOUND TO BE IN SAFETY MODE. SUBSEQUENTLY, A DEVICE REPLACEMENT PROCEDURE WAS PERFORMED, THE CRT-P WAS EXPLANTED AND REPLACED WITH A NEW DEVICE. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20364347 ↗
• MalfunctionJun 11, 2024Signal Artifact/Noise; Low impedance; Signal Artifact/Noise; Low impedance

  IT WAS REPORTED THAT THIS CARDIAC RESYNCHRONIZATION THERAPY PACEMAKER (CRT-P) SYSTEM EXHIBITED NOISE ON BOTH THE RIGHT ATRIAL (RA) AND RIGHT VENTRICULAR (RV) CHANNEL. ADDITIONALLY, BOTH LEADS HAD LOW OUT-OF-RANGE PACING LEAD IMPEDANCE MEASUREMENTS MEASURING LESS THAN 200 OHMS. BOTH LEADS ARE PROGRAMMED TOO UNIPOLAR. IT WAS NOTED THERE WAS INAPPROPRIATE MODE SWITCHING ON THE RA LEAD. LEAD WAS PROGRAMMED TEMPORARILY TO BIPOLAR AND NOISE WAS STILL PRESENT. TECHNICAL SERVICES DISCUSSED POSSIBLE CAUSES AND PROVIDED PROGRAMMING OPTIONS. AT THIS TIME, THE SYSTEM REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19510887 ↗
• InjuryMar 19, 2024High Capture Threshold; High Capture Threshold

  IT WAS REPORTED THAT THIS CARDIAC RESYNCHRONIZATION THERAPY PACEMAKER (CRT-P) WAS EXPLANTED TOGETHER WITH THE LEFT VENTRICULAR (LV) LEAD DUE TO HIGH PACING THRESHOLD AND A NEW LEAD WAS REQUIRED TO EXTEND BATTERY LONGEVITY. A NEW DEVICE WAS PLACED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18932827 ↗
• InjuryFeb 26, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THIS CARDIAC RESYNCHRONIZATION THERAPY PACEMAKER (CRT-P) WAS SURGICALLY REVISE DUE TO UNKNOWN REASON. THIS DEVICE REMAINS IN SERVICE. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED. ADDITIONAL INFORMATION RECEIVED INDICATES THAT THE POCKET REVISION WAS PERFORMED FOR COSMETIC REASONS AND THE DEVICE IS FINE WITH NO ISSUES. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18775647 ↗
• MalfunctionMay 3, 2023False Positive Result; False Positive Result

  IT WAS REPORTED THAT THIS CARDIAC RESYNCHRONIZATION THERAPY PACEMAKER (CRT-P) RECORDED TWO SIGNAL ARTIFACT MONITORING (SAM) EPISODES DUE TO OVERSENSING OF ATRIAL FIBRILLATION/ATRIAL FLUTTER. TECHNICAL SERVICES DISCUSSED AND RECOMMENDED FURTHER TESTING. NO ADVERSE PATIENT EFFECTS WERE REPORTED. THIS DEVICE REMAINS IN SERVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16865098 ↗
• MalfunctionNov 24, 2022Battery Problem; Battery Problem

  IT WAS REPORTED THAT THIS CARDIAC RESYNCHRONIZATION THERAPY PACEMAKER (CRT-P) WAS AT BATTERY LOW AND NEEDS REPLACEMENT. BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) RECOMMENDED PATIENT TO CALL BACK THE PERSON LEFT THE MESSAGE. THE DEVICE REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15863409 ↗
• MalfunctionJul 5, 2022Low impedance; Low impedance

  IT WAS REPORTED THAT THE PATIENT WITH THIS CARDIAC RESYNCHRONIZATION THERAPY PACEMAKER (CRT-P) SYSTEM STATED THAT THEIR REMOTE COMMUNICATOR DISPLAYED A RED CALL DOCTOR ICON. SUBSEQUENTLY, TROUBLESHOOTING WAS PERFORMED, AND THE COMMUNICATOR WAS POWER CYCLED, AND A SUCCESSFUL PATIENT-INITIATED INTERROGATION WAS SENT. THE DEVICE RECORDED A RED ALERT FOR LOW OUT OF RANGE PACING IMPEDANCES ON THE RIGHT ATRIAL (RA) AND RIGHT VENTRICULAR (RV) LEAD. THE LEADS HAVE BEEN IMPLANTED FOR SIXTEEN YEARS. THIS CTR-P SYSTEM REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14920665 ↗
• MalfunctionMay 31, 2022Signal Artifact/Noise; Failure to Capture; High impedance; High Capture Threshold; Signal Artifact/Noise; Failure to Capture; High impedance; High Capture Threshold

  IT WAS REPORTED THAT THIS CARDIAC RESYNCHRONIZATION THERAPY PACEMAKER (CRT-P) AND LEFT VENTRICULAR (LV) LEAD EXHIBITED IMPEDANCE MEASUREMENTS OF GREATER THAN 3000 OHMS, INCREASED THRESHOLDS, POSSIBLE LOSS OF LV CAPTURE, AND LOW LEVEL NOISE WITH PATIENT ISOMETRICS. TECHNICAL SERVICES (TS) DISCUSSED POSSIBLE TROUBLESHOOTING AND PROGRAMMING OPTIONS. NO ADVERSE PATIENT EFFECTS WERE REPORTED. THE DEVICE SYSTEM REMAINS IN SERVICE.

  Patient problems: Dizziness; No Clinical Signs, Symptoms or Conditions

  MAUDE report 14549892 ↗
• MalfunctionJun 21, 2019Device Displays Incorrect Message; Device Displays Incorrect Message

  IT WAS REPORTED THAT THIS DEVICE RECORDED A CODE 1003 DURING PRE-IMPLANT INTERROGATION DUE TO AN UNKNOWN REASON. THE DEVICE WAS INTERROGATED AGAIN, BUT THE ALERT WAS UNABLE TO BE CLEARED. NO PATIENT INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 8722880 ↗
• InjuryJun 21, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS CARDIAC RESYNCHRONIZATION THERAPY PACEMAKER (CRT-P) WAS PART OF A SYSTEM REVISION DUE TO INFECTION AND EROSION. THERE WERE NO ADDITIONAL ADVERSE PATIENT EFFECTS REPORTED. THE CRT-P WAS EXPLANTED.

  Patient problems: Pocket Erosion; Unspecified Infection

  MAUDE report 8722587 ↗
• MalfunctionOct 18, 2018High impedance; High impedance

  BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS CARDIAC RESYNCHRONIZATION THERAPY PACEMAKER (CRT-P) AND A NON-BOSTON SCIENTIFIC RIGHT ATRIAL (RA) LEAD EXHIBITED IMPEDANCE MEASUREMENTS OF GREATER THAN 2500 OHMS. THE RESPIRATORY RATE TREND (RRT) WAS PROGRAMMED OFF, AND THE DEVICE WAS LEFT PROGRAMMED TO UNIPOLAR CONFIGURATION. NO ADVERSE PATIENT EFFECTS WERE REPORTED. THE DEVICE REMAINS IN SERVICE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7977310 ↗
• MalfunctionApr 10, 2018High impedance; Use of Device Problem; Low impedance; High impedance; Use of Device Problem; Low impedance

  BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS CARDIAC RESYNCHRONIZATION THERAPY PACEMAKER (CRT-P) EXHIBITED LEFT VENTRICULAR (LV) IMPEDANCE MEASUREMENTS OF LESS THAN 200 OHMS, AS WELL AS HIGH IMPEDANCE MEASUREMENTS. THE PATIENT HAD TWO LV LEADS. NO ADVERSE PATIENT EFFECTS WERE REPORTED. THE DEVICE REMAINS IN SERVICE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7410871 ↗
• InjuryOct 10, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  BOSTON SCIENTIFIC RECEIVED INFORMATION 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 6936573 ↗

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-0102-2026 · Aug 20, 2025 · Open, Classified
  Model Number U128, VALITUDE CRT-P EL MRI
• Z-0101-2026 · Aug 20, 2025 · Open, Classified
  Model Number U125, VALITUDE CRT-P EL
• 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-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-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-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-0366-2018 · Dec 7, 2017 · Open, Classified
  VISIONIST X4 CRT-P Pacemaker
• Z-0365-2018 · Dec 7, 2017 · Open, Classified
  VISIONIST CRT-P Pacemaker

…and 3 more.