INVIVE™ V173Recalls & reported problems

Summary

The FDA's MAUDE database contains 670 adverse event reports that list this exact device (DI 00802526536632), received between Jan 8, 2015 and Oct 2, 2025 — classified as 1 death, 605 injuries, 64 malfunctions.

The most frequently reported specific device problem is “Incorrect, Inadequate or Imprecise Result or Readings” (472 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 25 most recent of 670 reports, in the reporter's own words as published by the FDA.

• InjuryOct 2, 2025Incorrect, Inadequate or Imprecise Result or Readings; Data Problem; Incorrect, Inadequate or Imprecise Result or Readings; Data Problem

  IT WAS REPORTED THAT THIS CARDIAC RESYNCHRONIZATION THERAPY PACEMAKER (CRT-P) EXHIBITED AN ALERT MESSAGE INDICATING THAT BATTERY REPLACEMENT INDICATOR HAD BEEN REACHED ON 17JUL2014. TECHNICAL SERVICES DISCUSSED THAT THIS WAS ASSOCIATED WITH UNEXPECTED HARDWARE RESETS AND THE DEVICE DATA WAS CONSISTENT WITH A HIGH IMPEDANCE BATTERY AND RECOMMENDED DEVICE REPLACEMENT. THIS DEVICE WAS SUBSEQUENTLY EXPLANTED AND WAS NOT RETURNED. OTHER THAN THE SURGICAL PROCEDURE, NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23200736 ↗
• InjurySep 3, 2025Signal Artifact/Noise; Failure to Capture; Inaccurate Synchronization; Signal Artifact/Noise; Failure to Capture; Inaccurate Synchronization

  IT WAS REPORTED THAT THE PATIENT WITH THIS CARDIAC RESYNCHRONIZATION THERAPY PACEMAKER (CRT-P) WENT INTO VENTRICULAR FIBRILLATION (VF) DURING A GENERATION CHANGE PROCEDURE. TECHNICAL SERVICES (TS) REVIEWED DEVICE DATA AND NOTED A PAUSE IN HEART RATE PRIOR TO ELECTROCAUTERY NOISE ON BOTH THE RIGHT ATRIAL AND RIGHT VENTRICULAR CHANNELS. TS NOTED THAT THE PATIENT'S RHYTHM WAS LIKELY ALREADY IN AN ARRHYTHMIA, HOWEVER RECOMMENDED PHYSICIAN REVIEW TO CONFIRM, BUT THE CAUSE WAS NOT DETERMINED. THE PATIENT WAS CONTINUOUSLY MONITORED AT THE HOSPITAL TO RESOLVE. THIS DEVICE WAS SUBSEQUENTLY EXPLANTED AND REPLACED DUE TO NORMAL BATTERY DEPLETION. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Bradycardia; Ventricular Fibrillation

  MAUDE report 22954379 ↗
• InjuryAug 12, 2025Pacing Problem; Incorrect, Inadequate or Imprecise Result or Readings; Pacing Problem; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT THIS PACEMAKER REVERTED TO SAFETY MODE AND THE BRADY RATE WAS NOT AS EXPECTED. THIS PACEMAKER WAS EXPLANTED AND SUCCESSFULLY REPLACED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED. THIS PRODUCT HAS NOT BEEN RECEIVED FOR ANALYSIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22784027 ↗
• InjuryMay 1, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT THIS CARDIAC RESYNCHRONIZATION THERAPY PACEMAKER (CRT-P) ENTERED SAFETY MODE. THIS CRT-P WAS EXPLANTED AND REPLACED WITH A NEW CRT-P. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21942351 ↗
• InjuryApr 23, 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) FELT THUMPING ON THEIR CHEST. TECHNICAL SERVICES (TS) WAS CONSULTED AND IT WAS DISCOVERED THIS CRT-P ENTERED SAFETY MODE, WITH THE SAFETY MODES UNIPOLAR PACING PROBABLY CAUSING THE THUMPING FELT BY THE PATIENT. THIS CRT-P WAS EXPLANTED. A NEW DEVICE WAS IMPLANTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Chest Pain; Unspecified Heart Problem

  MAUDE report 21891680 ↗
• InjuryApr 14, 2025Pacing Problem; Incorrect, Inadequate or Imprecise Result or Readings; Premature Discharge of Battery; Pacing Problem; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT THIS CARDIAC RESYNCHRONIZATION THERAPY PACEMAKER (CRT-P) WAS EXPLANTED DUE TO IT SWITCHED TO SAFETY MODE. A NEW DEVICE WAS SUCCESSFULLY IMPLANTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

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

  MAUDE report 21836656 ↗
• InjuryMar 10, 2025Defective Device; Defective Device

  IT WAS REPORTED THAT THIS CARDIAC RESYNCHRONIZATION THERAPY PACEMAKER (CRT-P) WAS EXPLANTED DUE TO A PRODUCT PERFORMANCE ISSUE. A NEW DEVICE WAS SUCCESSFULLY EXPLANTED. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21560706 ↗
• InjuryFeb 20, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT THIS CARDIAC RESYNCHRONIZATION THERAPY PACEMAKER (CRT-P) ENTERED SAFETY MODE. THE CRT-P WAS EXPLANTED, AND ANOTHER DEVICE WAS SUCCESSFULLY PLACED. THIS DEVICE WAS RECEIVED FOR ANALYSIS. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Inappropriate Device Stimulation of Tissue; No Clinical Signs, Symptoms or Conditions

  MAUDE report 21428990 ↗
• InjuryJan 20, 2025Over-Sensing; Incorrect, Inadequate or Imprecise Result or Readings; Interrogation Problem; Over-Sensing; Incorrect, Inadequate or Imprecise Result or Readings; Interrogation Problem

  IT WAS REPORTED THAT THIS CARDIAC RESYNCHRONIZATION THERAPY PACEMAKER (CRT P) WAS DIFFICULT TO INTERROGATE AND THE DEVICE WAS FOUND TO BE IN SAFETY MODE. THE DEVICE SWITCHED TO UNIPOLAR AND CAUSED POCKET STIMULATION. THIS CRTP WAS EXPLANTED AND SUCCESSFULLY REPLACED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Device Overstimulation of Tissue

  MAUDE report 21193488 ↗
• InjuryDec 17, 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) 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 20957145 ↗
• InjuryDec 10, 2024Incorrect, 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) VISITED THE EMERGENCY ROOM (ER) AFTER A SYNCOPE EPISODE. THE DEVICE WAS INTERROGATED AND FOUND TO BE IN SAFETY MODE. AN EMERGENT DEVICE REPLACEMENT PROCEDURE WAS PERFORMED, THE CRT-P WAS EXPLANTED AND REPLACED WITH A NEW DEVICE SUCCESSFULLY. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Syncope/Fainting

  MAUDE report 20895653 ↗
• InjuryDec 6, 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 EXPLANTED AND REPLACED DUE TO ENTERING SAFETY MODE. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED. PRODUCT RETURN WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20872512 ↗
• MalfunctionNov 11, 2024High impedance; Over-Sensing; High Capture Threshold; High impedance; Over-Sensing; High Capture Threshold

  IT WAS REPORTED THAT THIS CARDIAC RESYNCHRONIZATION THERAPY PACEMAKER (CRT-P) EXHIBITED FAR-FIELD OVERSENSING IN THE RIGHT ATRIAL (RA) CHANNEL. WHICH RESULTED IN INAPPROPRIATE ATRIAL TACHY RESPONSE (ATR) EPISODES TO BE STORED. REPROGRAMMING OPTIONS AND SENSITIVITY ADJUSTMENTS WERE PERFORMED. SUBSEQUENTLY, THE LEFT VENTRICULAR (LV) ACTIVITY STARTED TO BE SENSED ON THE RA CHANNEL. TS RECOMMENDED TURNING OFF THE LV SENSITIVITY, BUT IT REMAINED AT THE PHYSICIAN DISCRETION. IN ADDITION, THIS CRT-P SYSTEM PRESENTED HIGH OUT OF RANGE PACING IMPEDANCE MEASUREMENTS WITH HIGH PACING THRESHOLDS. THIS CRT-P REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20654091 ↗
• MalfunctionOct 9, 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. THE PATIENT EXPERIENCED PHRENIC NERVE STIMULATION. BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) WAS CONSULTED AND DEVICE REPLACEMENT WAS RECOMMENDED. NO ADVERSE PATIENT EFFECTS WERE REPORTED. AT THIS TIME, THIS DEVICE REMAINS IN SERVICE.

  Patient problems: Device Overstimulation of Tissue

  MAUDE report 20409282 ↗
• InjuryOct 2, 2024Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT THIS PACEMAKER RECORDED A 1010 ERROR CODE WHEN INTERROGATING THE DEVICE. THE PATIENT MENTIONED HAVING FELL AND THEN THE PACEMAKER WAS EXPLANTED AND RETURNED FOR ANALYSIS. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Fall

  MAUDE report 20350175 ↗
• InjurySep 30, 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 CHANGE OUT 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 20335420 ↗
• InjurySep 26, 2024Extracardiac stimulation; Incorrect, Inadequate or Imprecise Result or Readings; Extracardiac stimulation; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT THIS CARDIAC RESYNCHRONIZATION THERAPY PACEMAKER (CRT-P) FELT INTO SAFETY MODE. THE PATIENT EXPERIENCED MUSCLE STIMULATION, AND THE DEVICE WAS EXPLANTED AND REPLACED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Device Overstimulation of Tissue

  MAUDE report 20310417 ↗
• MalfunctionSep 24, 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 20297607 ↗
• InjurySep 3, 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. THE DEVICE IS SCHEDULE TO BE EXPLANTED. NO ADVERSE PATIENT EFFECTS WERE REPORTED. ADDITIONAL INFORMATION WAS RECEIVED, MENTIONING THAT THIS DEVICE WAS SUCCESSFULLY EXPLANTED AND REPLACED DUE TO SAFETY SWITCH. THE DEVICE IS EXPECTED TO RETURN FOR ANALYSIS. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20128615 ↗
• InjuryAug 14, 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 PART OF A SYSTEM REVISION DUE TO INFECTION. THERE WERE NO ADDITIONAL ADVERSE PATIENT EFFECTS REPORTED. THIS CRT-P WAS EXPLANTED.

  Patient problems: Unspecified Infection

  MAUDE report 19983269 ↗
• InjuryAug 9, 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. THE PATIENT EXPERIENCED A SYNCOPAL EPISODE. 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: Syncope/Fainting

  MAUDE report 19956389 ↗
• InjuryJul 18, 2024Signal Artifact/Noise; Incorrect, Inadequate or Imprecise Result or Readings; Signal Artifact/Noise; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT THIS CARDIAC RESYNCHRONIZATION THERAPY PACEMAKER (CRT-P) REVERTED TO SAFETY MODE AND NOISE COULD BE SEEN IN THE RIGHT VENTRICULAR CHANNEL. IT WAS NOTED THAT THE PATIENT IS NOT DEPENDENT AND THAT THERE IS NO EVIDENCE OF PACING INHIBITION. TS REVIEWED LATITUDE AND DID NOT SEE ANY EPISODES WITH RIGHT VENTRICULAR NOISE. THIS DEVICE WAS EXPLANTED AND SUCCESSFULLY REPLACED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19779210 ↗
• InjuryJul 16, 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. THE PATIENT EXPERIENCED MUSCLE STIMULATION FROM THE UNIPOLAR PACING CONFIGURATION. A DEVICE CHANGEOUT PROCEDURE WAS PERFORMED AND IT WAS EXPLANTED AND REPLACED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Device Overstimulation of Tissue

  MAUDE report 19756985 ↗
• InjuryJul 11, 2024Incorrect, 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) DEVICE WAS FOUND IN SAFETY MODE DURING THE VISIT IN CLINIC. TECHNICAL SERVICES (TS) RECOMMENDED TO HAVE THIS DEVICE CHANGEOUT SOON. BOSTON SCIENTIFIC REPRESENTATIVE STATED THAT THE PATIENT WAS NOT FEELING WELL AND HAD COMPLETE HEART BLOCK. SUBSEQUENTLY THIS DEVICE WAS EXPLANTED AND SUCCESSFULLY REPLACED. NO ADDITIONAL PATIENT ADVERSE EFFECTS WERE REPORTED.

  Patient problems: Discomfort

  MAUDE report 19719909 ↗
• InjuryJul 1, 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) HAD ENTERED SAFETY MODE AND PREMATURE BATTERY DEPLETION WAS SUSPECTED. THE PHYSICIAN OPTED TO EXPLANT AND REPLACE THIS DEVICE. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE. THIS DEVICE HAS NOT RETURNED FOR ANALYSIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19651969 ↗

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-2019-2021 · Jun 3, 2021 · Open, Classified
  INTUA CRT-P, Model Numbers: a) V272 b) V273 c) W273
• 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-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-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.