INTUARecalls & reported problems across all models

We found 2 models of INTUA by Boston Scientific Corporation in the FDA's device registry (GUDID). Together they are named in 287 adverse event reports in the FDA's MAUDE database, received between Apr 22, 2016 and Jul 27, 2026 — classified as 253 injuries, 34 malfunctions.

The most frequently reported specific device problem is “Incorrect, Inadequate or Imprecise Result or Readings” (145 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Most reported INTUA problems

INTUA models

2 models, most reported first. Each model has its own page with its reports, recalls and device details.

• INTUA™ V273

  Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)
  264 reports
• INTUA™ V272

  Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)
  23 reports

Recent INTUA adverse event reports

The 15 most recent reports across all models, 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 14, 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 PACEMAKER ENTERED INTO SAFETY MODE AND WAS EXPLANTED AT A SURGICAL INTERVENTION. THE PACEMAKER IS EXPECTED TO BE RETURNED FOR ANALYSIS. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20680484 ↗
• 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 ↗

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