INTUA™ V273Recalls & reported problems

Summary

The FDA's MAUDE database contains 264 adverse event reports that list this exact device (DI 00802526536670), received between Apr 22, 2016 and Jul 27, 2026 — classified as 233 injuries, 31 malfunctions.

The most frequently reported specific device problem is “Incorrect, Inadequate or Imprecise Result or Readings” (137 reports).

20 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.

Most reported problems

Recent adverse event reports

The 25 most recent of 264 reports, in the reporter's own words as published by the FDA.

• InjuryJul 27, 2026Incorrect, Inadequate or Imprecise Result or Readings

  It was reported that this cardiac resynchronization therapy pacemaker (CRT-P) was interrogated and was found to be in safety mode. It was noted the physician stated the device was close to Elective Replacement Indicator (ERI) approximately one year ago and told the patient to follow up in one month however, the patient did not follow up. Subsequently, this CRT-P was explanted and successfully replaced. No additional adverse patient effects were reported. This CRT-P has not been returned for analysis.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50035875 ↗
• InjuryDec 11, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THIS CARDIAC RESYNCHRONIZATION THERAPY PACEMAKER (CRT-P) WAS EXPLANTED DUE TO A PRODUCT PERFORMANCE ISSUE. THIS DEVICE WAS SUCCESSFULLY REPLACED WITH ANOTHER MODEL. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED OUTSIDE THE REVISION PROCEDURE. THIS PRODUCT HAS NOT BEEN RETURNED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23780842 ↗
• InjuryDec 8, 2025Incorrect, Inadequate or Imprecise Result or Readings; Insufficient Device Problem Information; Incorrect, Inadequate or Imprecise Result or Readings; Insufficient Device Problem Information

  CARDIAC RESYNCHRONIZATION THERAPY PACEMAKER (CRT-P) THE DEVICE WAS EXPLANTED AND REPLACED. NO ADVERSE PATIENT EFFECTS WERE REPORTED.ADDITIONAL INFORMATION WAS OBTAINED, THE DEVICE WAS EXPLANTED AND REPLACED DUE TO BEING IN SAFETY MODE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23743511 ↗
• InjuryNov 18, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT THE PATIENT WITH THIS CARDIAC RESYNCHRONIZATION THERAPY PACEMAKER (CRT-P) CALLED TECHNICAL SERVICES (TS) TO STATE THAT THEIR CLINIC HAD CONTACTED THEM SAYING THE DEVICE WAS IN EMERGENCY MODE. IN ADDITION, THE PATIENT STATED FEELING PALPITATIONS. THIS DEVICE DOES NOT HAVE A MODE SPECIFICALLY CALLED EMERGENCY MODE. TS RECOMMENDED A FOLLOW UP WITH THE CLINIC. ADDITIONAL INFORMATION WAS PROVIDED STATING THAT THE DEVICE REVERTED TO SAFETY MODE FOR WHICH THE DEVICE WAS SUBSEQUENTLY EXPLANTED AND REPLACED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED. THIS DEVICE HAS NOT BEEN RETURNED FOR ANALYSIS.

  Patient problems: Palpitations; Unspecified Heart Problem

  MAUDE report 23586678 ↗
• InjurySep 11, 2025Pacing Problem; Incorrect, Inadequate or Imprecise Result or Readings; Pacing Problem; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT THIS CARDIAC RESYNCHRONIZATION THERAPY PACEMAKER (CRT-P) ENTERED SAFETY MODE, WITH A PAUSE IN PACING BETWEEN 2-3 SECONDS THAT RESULTED IN ASYSTOLE, WITH THE PATIENT ASYMPTOMATIC. THIS DEVICE WAS SUBSEQUENTLY EXPLANTED. A NEW DEVICE WAS IMPLANTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Asystole

  MAUDE report 23027447 ↗
• InjuryAug 13, 2025Incorrect, Inadequate or Imprecise Result or Readings; Defective Device; Incorrect, Inadequate or Imprecise Result or Readings; Defective Device

  IT WAS REPORTED THAT THIS CARDIAC RESYNCHRONIZATION THERAPY PACEMAKER (CRT-P) WAS EXPLANTED AND REPLACED DUE TO UNKNOWN PRODUCT PERFORMANCE ISSUE. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22796812 ↗
• MalfunctionMar 26, 2025Failure to Capture; Over-Sensing; Pacing Problem; Defective Device; Failure to Capture; Over-Sensing; Pacing Problem; Defective Device

  IT WAS REPORTED THAT THIS CARDIAC RESYNCHRONIZATION THERAPY PACEMAKER (CRT-P) EXHIBITED OVERSENSING ON THE RIGHT VENTRICULAR (RV) LEAD CHANNEL WHICH LED TO PACING INHIBITION, WHICH LASTED LESS THAN TWO SECONDS. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED. THIS DEVICE WAS EXPLANTED DUE TO NORMAL BATTERY DEPLETION.

  Patient problems: Heart Block; Insufficient Information

  MAUDE report 21696508 ↗
• MalfunctionJan 2, 2025Defective Device; Defective Device

  IT WAS REPORTED THAT THIS CARDIAC RESYNCHRONIZATION THERAPY PACEMAKER (CRT-P) DEVICE WAS RECEIVED BY POST MARKET QUALITY ASSURANCE FOR ANALYSIS WITHOUT ALLEGATION FROM THE FIELD. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21063740 ↗
• MalfunctionDec 9, 2024Defective Device; Defective Device

  IT WAS REPORTED THAT THIS DEVICE WAS RECEIVED BY POST MARKET QUALITY ASSURANCE WITHOUT A KNOWN REASON FOR EXPLANT. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20883782 ↗
• InjuryNov 26, 2024Defective Device; Defective Device

  IT WAS REPORTED THAT THIS IMPLANTABLE PACEMAKER WAS EXPLANTED DUE TO NON-SPECIFIC PRODUCT PERFORMANCE ISSUE. A NEW DEVICE WAS SUCCESSFULLY IMPLANTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

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

  MAUDE report 20782121 ↗
• InjuryNov 5, 2024Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT THIS CARDIAC RESYNCHRONIZATION THERAPY PACEMAKER (CRTP) REVERTED TO SAFETY MODE. THIS DEVICE WAS EXPLANTED AND SUCCESSFULLY REPLACED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20612903 ↗
• InjuryOct 31, 2024Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT THIS CARDIAC RESYNCHRONIZATION THERAPY PACEMAKER (CRT-P) WAS FOUND TO BE IN SAFETY MODE. A DEVICE CHANGEOUT PROCEDURE WAS PERFORMED AND IT WAS EXPLANTED AND REPLACED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED. THIS DEVICE HAS BEEN RECEIVED FOR ANALYSIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20579777 ↗
• MalfunctionOct 29, 2024Defective Device; Defective Device

  IT WAS REPORTED THAT THIS CARDIAC RESYNCHRONIZATION THERAPY PACEMAKER (CRT-P) WAS EXPLANTED AND RETURNED WITHOUT AN ALLEGATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20559516 ↗
• InjuryOct 3, 2024Defective Device; Defective Device

  IT WAS REPORTED THAT THIS IMPLANTABLE PACEMAKER WAS EXPLANTED DUE TO NON-SPECIFIC PRODUCT PERFORMANCE ISSUE. A NEW DEVICE WAS SUCCESSFULLY IMPLANTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20357507 ↗
• MalfunctionSep 17, 2024Defective Device; Defective Device

  IT WAS REPORTED THAT THIS CARDIAC RESYNCHRONIZATION THERAPY PACEMAKER (CRT-P) WAS RETURNED WITH NO REPORTED PRODUCT PERFORMANCE ISSUES OR ADVERSE PATIENT EFFECTS. ANALYSIS COMPLETED IN OUR POST MARKET QUALITY ASSURANCE LABORATORY DETERMINED THAT THIS CRT-P EXHIBITED PREMATURE BATTERY DEPLETION DUE TO HIGH BATTERY IMPEDANCE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20238712 ↗
• InjurySep 3, 2024Pacing Problem; Pacing Problem

  IT WAS REPORTED THAT THIS CARDIAC RESYNCHRONIZATION THERAPY PACEMAKER (CRT-P) SWITCHED TO UNIPOLAR MODE AND EXPERIENCED PACING INHIBITION GREATER THAN 2 SECONDS. SUBSEQUENTLY, A REVISION PROCEDURE WAS PERFORMED AND THE CRT-P WAS EXPLANTED AND REPLACED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Asystole

  MAUDE report 20128008 ↗
• InjuryAug 26, 2024Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT THIS CARDIAC RESYNCHRONIZATION THERAPY PACEMAKER (CRT-P) FELL INTO SAFETY MODE. TECHNICAL SERVICES (TS) WAS CONSULTED AND EXPLAINED POSSIBLE SENSING COMPLICATIONS. TS RECOMMENDED DEVICE REPLACEMENT. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20064156 ↗
• InjuryAug 12, 2024Premature Discharge of Battery; Incorrect, Inadequate or Imprecise Result or Readings; Premature Discharge of Battery; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT THIS CARDIAC RESYNCHRONIZATION THERAPY PACEMAKER (CRT-P) EXHIBITED PREMATURE BATTERY DEPLETION (PBD) AND WAS FOUND TO BE IN SAFETY MODE. A DEVICE CHANGEOUT PROCEDURE WAS PERFORMED AND IT WAS EXPLANTED AND REPLACED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED. IT IS EXPECTED TO RECEIVE THIS DEVICE FOR ANALYSIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19968795 ↗
• InjuryAug 8, 2024Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT THIS CARDIAC RESYNCHRONIZATION THERAPY PACEMAKER (CRT-P) WAS FOUND TO BE IN SAFETY MODE. BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) WAS CONSULTED AND DEVICE REPLACEMENT WAS RECOMMENDED. FURTHER INFORMATION WAS RECEIVED THAT A DEVICE CHANGEOUT PROCEDURE WAS PERFORMED AND IT WAS EXPLANTED AND REPLACED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19945696 ↗
• InjuryJul 25, 2024Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT THIS CARDIAC RESYNCHRONIZATION THERAPY PACEMAKER (CRT-P) DEVICE WAS EXPLANTED AND SUCCESSFULLY REPLACED DUE TO DEVICE FOUND IN SAFETY MODE. NO ADDITIONAL PATIENT ADVERSE EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19827410 ↗
• InjuryJul 4, 2024Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT THIS CARDIAC RESYNCHRONIZATION THERAPY PACEMAKER (CRT-P) WAS IN OFFICE CHECK AND THE CRT-P WAS AT LESS THAN 3 MONTHS. THEN, THE PATIENT LEFT THE OFFICE AND EXPERIENCED PALPITATIONS AND DIAPHRAGMATIC STIMULATION. THE PATIENT CAME BACK INTO THE OFFICE AND IT WAS FOUND THAT THE CRT-P WAS IN SAFETY MODE. DEVICE REPLACEMENT WAS RECOMMENDED. SUBSEQUENTLY, A REVISION PROCEDURE WAS PERFORMED AND THE CRT-P WAS EXPLANTED AND REPLACED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Device Overstimulation of Tissue; Unspecified Heart Problem

  MAUDE report 19675389 ↗
• InjuryJul 3, 2024Pacing Problem; Incorrect, Inadequate or Imprecise Result or Readings; Pacing Problem; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT THIS CARDIAC RESYNCHRONIZATION THERAPY PACEMAKER (CRT-P) ENTERED SAFETY MODE, AND THIS DEVICE EXHIBITED PAUSES DUE TO UNIPOLAR PACING IN SAFETY MODE. IT WAS SUSPECTED THAT THERE WAS GREATER THAN TWO SECOND OF ASYSTOLE, AS THE PATIENT WAS SYMPTOMATIC. THIS CRT-P WAS EXPLANTED AND REPLACED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED. THIS DEVICE IS EXPECTED TO BE RETURNED FOR ANALYSIS.

  Patient problems: Asystole; Presyncope

  MAUDE report 19669659 ↗
• MalfunctionJun 12, 2024Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT THIS CARDIAC RESYNCHRONIZATION THERAPY PACEMAKER (CRT-P) WAS FOUND TO BE IN SAFETY MODE DURING A ROUTINE CHECKUP. THE HEALTH CARE PROFESSIONAL (HCP) CALLED TECHNICAL SERVICES (TS) AND REQUESTED A REVIEW OF THE PRESENTING ELECTROGRAM (EGM). UPON REVIEW, TS CONFIRMED ERROR MESSAGE RECEIVED THAT STATED THE CRT-P DEVICE WAS IN SAFETY MODE. TS DISCUSSED THE REVIEW WITH THE HCP AND RECOMMENDED FOR A GENERATOR REPLACEMENT PROCEDURE TO BE PERFORMED. AT THIS TIME, THE CRT-P REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19525119 ↗
• InjuryMay 23, 2024Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT THIS CARDIAC RESYNCHRONIZATION THERAPY PACEMAKER (CRT-P) DEVICE HAD AN ERROR MESSAGE. SUBSEQUENTLY, THE DEVICE WAS EXPLANTED EARLIER THAN ANTICIPATED AND THE PATIENT WAS IMPLANTED WITH A NEW DEVICE. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19383368 ↗
• InjuryMay 20, 2024Failure to Capture; Incorrect, Inadequate or Imprecise Result or Readings; Failure to Capture; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT THIS PACEMAKER WAS FOUND TO BE IN SAFETY MODE. DEVICE REPLACEMENT WAS RECOMMENDED. SUBSEQUENTLY, A REVISION PROCEDURE WAS PERFORMED AND THE PACEMAKER WAS EXPLANTED AND REPLACED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19355917 ↗

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-0103-2026 · Aug 20, 2025 · Open, Classified
  Model Number U225 VISIONIST CRT-P EL
• Z-0104-2026 · Aug 20, 2025 · Open, Classified
  Model Number U226, VISIONIST CRT-P EL
• Z-0102-2026 · Aug 20, 2025 · Open, Classified
  Model Number U128, VALITUDE CRT-P EL MRI
• Z-0105-2026 · Aug 20, 2025 · Open, Classified
  Model Number U228, VISIONIST CRT-P EL MRI
• 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-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-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-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)

…and 5 more.