INVIVE™ V172Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 00802526536625), received between Jan 26, 2021 and Mar 31, 2023 — classified as 8 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Incorrect, Inadequate or Imprecise Result or Readings” (9 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• InjuryMar 31, 2023Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT THE BOSTON SCIENTIFIC REPRESENTATIVE SAW THAT THE CARDIAC RESYNCHRONIZATION THERAPY PACEMAKER (CRT-P) WAS IN SAFETY MODE AT THE SATELLITE CLINIC. IT WAS NOTED THAT THE PATIENT WAS DEPENDENT ON DEVICE THERAPY BUT WAS FEELING FINE. THE DEVICE WAS EXPLANTED AND REPLACED. ANOTHER BOSTON SCIENTIFIC REPRESENTATIVE WAS PRESENT DURING THE EXPLANT AND NOTED THAT THE DEVICE WAS NOT IN SAFETY MODE. TECHNICAL SERVICES (TS) NOTED THAT IT IS NOT POSSIBLE FOR DEVICE TO PULL OUT OF SAFETY MODE. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED. THE DEVICE IS CURRENTLY IN HOSPITAL POSSESSION BUT IS EXPECTED TO BE RETURNED FOR ANALYSIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16654996 ↗
• MalfunctionFeb 20, 2023Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT THIS PACEMAKER WAS FOUND TO BE OPERATING IN SAFETY MODE. DUE TO PATIENTS AGE AND PREEXISTING CONDITIONS, THE DECISION WAS MADE NOT TO REPLACE THE DEVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16401612 ↗
• MalfunctionFeb 10, 2023Incorrect, 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) WAS SENT FROM THE NURSING HOME TO THE EMERGENCY ROOM (ER) DUE TO THE ALLEGATION OF THE PATIENT GOT SHOCKED. NONETHELESS, THE FIELD REPRESENTATIVE CLARIFIED THAT IT WAS NOT POSSIBLE BECAUSE THE DEVICE IS CRT-P AND THE PATIENT WAS SENT TO THE NURSING HOME. FURTHERMORE, THE CRT-P WAS FOUND TO BE IN SAFETY MODE. THE PATIENT IS ATRIAL PACING DEPENDENT. IT WAS RECOMMENDED THAT THIS DEVICE BE REPLACED, NONETHELESS, THE PATIENT REFUSED TO A REPLACEMENT. THIS CRT-P REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16353206 ↗
• InjuryDec 12, 2022Premature 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) WAS FOUND TO BE IN SAFETY MODE DURING A ROUTINE CHECK. ADDITIONALLY, THERE WERE CONCERNS REGARDING PREMATURE BATTERY DEPLETION OF THIS CRT-P. A REVISION PROCEDURE WAS PERFORMED AND THE CRT-P WAS EXPLANTED AND REPLACED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15959025 ↗
• InjurySep 16, 2022Over-Sensing; Pacing Problem; Incorrect, Inadequate or Imprecise Result or Readings; Over-Sensing; Pacing Problem; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT THIS IMPLANTABLE PACEMAKER EXHIBITED OVERSENSING AND PACING INHIBITION, FURTHERMORE, IT ENTERED IN SAFETY MODE. REPLACEMENT OF THE DEVICE WAS RECOMMENDED. ADDITIONALLY, THIS PATIENT EXPERIENCED A SYNCOPE EPISODE. THIS DEVICE WAS EXPLANTED AND REPLACED. NO FURTHER ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Asystole; Syncope/Fainting

  MAUDE report 15442249 ↗
• InjuryApr 9, 2022Incorrect, 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 OPERATING IN SAFETY MODE. THE DEVICE WAS SUBSEQUENTLY EXPLANTED AND REPLACED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED. AT THIS TIME, THE PRODUCT HAS NOT BEEN RETURNED. IF THE PRODUCT IS RETURNED, ANALYSIS WILL BE PERFORMED AND THIS REPORT WOULD BE UPDATED AT THAT TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14068810 ↗
• InjuryJan 1, 2022Incorrect, 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 EXHIBITED A REMOTE MONITORING ALERT INDICATING THE DEVICE REVERTED TO SAFETY MODE WITH LIMITED CRITICAL THERAPY STILL AVAILABLE, SPECIFICALLY UNIPOLAR SENSING AND PACING AT A FIXED RATE. THE HEALTHCARE PROVIDER (HCP) INDICATED THAT THIS IS A NEW PATIENT TO THEIR CLINIC AND NOTED THAT OTHER THAN THE SAFETY MODE ALERT MESSAGE, ALL REMOTE MONITORING DATA IS FROM THE PREVIOUS REMOTE DEVICE INTERROGATION WHICH OCCURRED TEN DAYS BEFORE THE ALERT. AT THE TIME OF THE PREVIOUS REMOTE DEVICE INTERROGATION, THE DEVICE HAD AN APPROXIMATED TEN MONTHS OF BATTERY LONGEVITY REMAINING. THE HCP ALSO NOTED THAT THE PATIENTS UNDERLYING RHYTHM IS UNKNOWN. BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) DISCUSSED SAFETY MODE WITH THE HCP, EXPLAINING THAT THE CAUSE IS UNKNOWN UNTIL THE DEVICE IS REPLACED AND RETURNED FOR A DETAILED ANALYSIS. THE HCP INDICATED THEY WILL REVIEW AND DISCUSS THIS WITH THE PHYSICIAN. THE DEVICE WAS SUBSEQUENTLY RETURNED TO BOSTON SCIENTIFIC, INDICATING IT WAS EXPLANTED. NO FURTHER INFORMATION HAS BEEN PROVIDED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13137278 ↗
• InjuryOct 12, 2021Defective Device; Defective Device

  IT WAS REPORTED THAT THIS PACEMAKER WAS EXPLANTED AND REPLACED DUE TO BEING ON AN ADVISORY. THE NEW DEVICE REMAINS IN SERVICE. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12620052 ↗
• InjuryJul 4, 2021Incorrect, 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 WITH LIMITED FUNCTIONALITY. TECHNICAL SERVICES RECOMMENDED TO REPLACE AND SEND BACK THE DEVICE. AT THIS TIME, THE DEVICE REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12114382 ↗
• InjuryJan 26, 2021Over-Sensing; Pacing Problem; Incorrect, Inadequate or Imprecise Result or Readings; Over-Sensing; Pacing Problem; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT THIS CARDIAC RESYNCHRONIZATION THERAPY PACEMAKER (CRT-P) HAD ENTERED SAFETY MODE, AND THE ASSOCIATED CODES WERE 0X40, 0X0, 0X0. THE PATIENT PRESENTED TO THE EMERGENCY ROOM (ER) DUE TO SYNCOPE. ADDITIONAL INFORMATION RECEIVED INDICATED THAT THIS CRT-P EXHIBITED OVERSENSING AND PACING INHIBITION WITH GREATER THAN TWO SECONDS OF ASYSTOLE. THIS CRT-P WAS EXPLANTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Code Available; Syncope; Syncope/Fainting

  MAUDE report 11234100 ↗

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-0105-2026 · Aug 20, 2025 · Open, Classified
  Model Number U228, VISIONIST CRT-P EL MRI
• 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-0826-2025 · Dec 12, 2024 · Open, Classified
  VALITUDE CRT-P, EL (Model Number U125) and EL MRI (Model Number U128)
• Z-0827-2025 · Dec 12, 2024 · Open, Classified
  VISIONIST CRT-P, EL (Model Number U225 and U226) and EL MRI (Model Number U228)
• 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-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-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)

…and 5 more.