INTUA™ V272Recalls & reported problems

Summary

The FDA's MAUDE database contains 23 adverse event reports that list this exact device (DI 00802526536663), received between Apr 25, 2016 and Nov 14, 2024 — classified as 20 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Incorrect, Inadequate or Imprecise Result or Readings” (8 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 23 most recent of 23 reports, in the reporter's own words as published by the FDA.

• 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 ↗
• InjurySep 12, 2023Incorrect, Inadequate or Imprecise Result or Readings; Interrogation Problem; Incorrect, Inadequate or Imprecise Result or Readings; Interrogation Problem

  IT WAS REPORTED THAT THIS CARDIAC RESYNCHRONIZATION THERAPY PACEMAKER (CRT-P) COULD NOT BE INTERROGATED WITH A CONSULT DEVICE AS IT HAD ENTERED INTO SAFETY MODE. THE CRT-P HAS BEEN EXPLANTED AND RETURNED FOR ANALYSIS AT THIS TIME. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17727028 ↗
• InjuryJul 6, 2023Signal Artifact/Noise; Failure to Capture; Over-Sensing; Pacing Problem; Incorrect, Inadequate or Imprecise Result or Readings; Signal Artifact/Noise; Failure to Capture; Over-Sensing; Pacing Problem; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT, THAT THE PATIENT WITH THIS CARDIAC RESYNCHRONIZATION THERAPY PACEMAKER (CRT-P) EXHIBITED LOSS OF CAPTURE (LOC) OR PACING INHIBITION. UPON REVIEW, THE CRT-P WAS FOUND IN SAFETY MODE. SUBSEQUENTLY, THIS DEVICE WAS EXPLANTED AND REPLACED. NO ADDITIONAL ADVERSE PATIENT EVENTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17274553 ↗
• InjuryMar 6, 2023Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT THIS CARDIAC RESYNCHRONIZATION THERAPY PACEMAKER (CRT-P) SWITCHED INTO SAFETY MODE, A DEVICE STATUS THAT PERMANENTLY LIMITS AVAILABLE THERAPY TO SPECIFIC SETTINGS. DEVICE REPLACEMENT WAS RECOMMENDED AS THERAPEUTIC NEEDS OF THE PATIENT MAY BE COMPROMISED. HOWEVER, THE DEVICE HAS CONTINUED TO DELIVER APPROPRIATE PACING. SUBSEQUENTLY, THIS CRT-P WAS EXPLANTED, REPLACED AND WAS RETURNED FOR ANALYSIS. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16492818 ↗
• InjuryFeb 13, 2023Pacing 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) HAD ENTERED SAFETY MODE. TECHNICAL SERVICES (TS) WAS CONSULTED AND RECOMMENDED DEVICE EXPLANT. A PACEMAKER MEDIATED TACHYCARDIA (PMT) WAS ALSO RECORDED. THE CRT-D WAS EXPLANTED AND SUCCESSFULLY REPLACED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16363762 ↗
• InjuryJan 16, 2023Incorrect, 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 HAS BEEN SCHEDULED. ADDITIONAL INFORMATION WAS RECEIVED THAT THIS DEVICE WAS EXPLANTED AND REPLACED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16174603 ↗
• MalfunctionDec 30, 2022Incorrect, Inadequate or Imprecise Result or Readings; Adverse Event Without Identified Device or Use Problem; Incorrect, Inadequate or Imprecise Result or Readings; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THIS CARDIAC RESYNCHRONIZATION THERAPY PACEMAKER (CRT-P) ENTERED INTO SAFETY MODE. THE CRT-P REMAINS IN SERVICE AT THIS TIME. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16076651 ↗
• InjuryOct 11, 2022Incorrect, 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 DUE TO AN UNKNOWN PRODUCT PERFORMANCE ISSUE. A NEW DEVICE WAS SUCCESSFULLY IMPLANTED. NO ADDITIONAL PATIENT ADVERSE EFFECTS WERE REPORTED. IT IS UNKNOWN IF THIS DEVICE WILL BE RETURNED TO BOSTON SCIENTIFIC FOR ANALYSIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15581334 ↗
• InjurySep 26, 2022High impedance; High impedance

  THIS CARDIAC RESYNCHRONIZATION THERAPY PACEMAKER (CRT-P) AND LEFT VENTRICULAR (LV) LEAD TRIGGERED A LEAD SAFETY SWITCH (LSS) TO UNIPOLAR DUE TO A HIGH OUT-OF-RANGE PACE IMPEDANCE MEASUREMENT OF 2,012 OHMS. THE VECTOR WAS REPROGRAMMED SUCCESSFULLY AND THE LSS FOR THE LV LEAD WAS PROGRAMMED OFF. THIS CRT-P AND LV LEAD REMAIN IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15486097 ↗
• InjuryMay 5, 2022Battery Problem; Battery Problem

  IT WAS REPORTED THAT THERE WAS A PROBLEM WITH THE BATTERIES OF THIS CARDIAC RESYNCHRONIZATION THERAPY PACEMAKER (CRT-P) DEVICE. SUBSEQUENTLY, THE PATIENT UNDERWENT A REPLACEMENT PROCEDURE, AND THIS DEVICE WAS EXPLANTED AND REPLACED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14291083 ↗
• MalfunctionDec 20, 2021Signal Artifact/Noise; Pacing Problem; Signal Artifact/Noise; Pacing Problem

  IT WAS REPORTED THAT THE PATIENT WITH THIS CARDIAC RESYNCHRONIZATION THERAPY PACEMAKER (CRT-P) IS PACING DEPENDENT AND IS A HIGH IMPEDANCE ADVISORY DEVICE. THE PATIENT WAS CHECKED IN CLINIC TODAY AND THE HEALTH CARE PROFESSIONAL (HCP) PROGRAMMED THE DEVICE FOR SAFETY MODE SIMULATION, CONFIRMING PATIENT SYMPTOMS AND DEVICE CRITERIA FOR EARLY DEVICE CHANGE-OUT. TECHNICAL SERVICES (TS) REVIEWED AND DISCUSSED THAT EARLY REPLACEMENT IS AT THE DISCRETION OF THE FOLLOWING PHYSICIAN, AND CAN BE DONE AT ANY POINT GIVEN THE PATIENT IS ON THE ADVISORY LIST AND HAS SYMPTOMS DURING SAFETY MODE SIMULATION. NO ADVERSE PATIENT EFFECTS WERE REPORTED. AT THIS TIME, THE DEVICE REMAINS IN SERVICE.

  Patient problems: Discomfort

  MAUDE report 13048319 ↗
• InjuryOct 12, 2021Premature Discharge of Battery; Premature Discharge of Battery

  IT WAS REPORTED THAT THIS CARDIAC RESYNCHRONIZATION THERAPY PACEMAKER (CRT-P) EXHIBITED PREMATURE BATTERY DEPLETION (PBD). THE DEVICE WAS EXPLANTED NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12620162 ↗
• InjuryAug 4, 2021Defective Device; Defective Device

  IT WAS REPORTED THAT THIS PACEMAKER WAS EXPLANTED AND REPLACED AS A RESULT OF THE DEVICE BEING INCLUDED IN THE HIGH IMPEDANCE IN INGENIO EXTENDED LIFE (EL) PACEMAKER AND CRT-P ADVISORY POPULATION. IN ADDITION, IT WAS REPORTED THAT THIS PATIENT IS DEPENDENT. THERE WERE NO PATIENT SYMPTOMS REPORTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12278104 ↗
• MalfunctionNov 7, 2018Premature Discharge of Battery; High Capture Threshold; Premature Discharge of Battery; High Capture Threshold

  IT WAS REPORTED THAT THIS CARDIAC RESYNCHRONIZATION THERAPY PACEMAKER DECLARED ELECTIVE REPLACEMENT INDICATOR LESS THAN TWO YEARS AFTER IT WAS FIRST IMPLANTED. BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) DISCUSSED THE LEFT VENTRICULAR LEAD EXHIBITED AN ELEVATED OUTPUT. AS RESULT, THE BATTERY CONSUMPTION WAS FASTER THAN EXPECTED. TS SUGGESTED REPLACING THE DEVICE SHORTLY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8045349 ↗
• InjuryMar 19, 2018Migration or Expulsion of Device; Migration or Expulsion of Device

  BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS PATIENT COMPLAINED OF A PULLING SENSATION WHEN HE MOVED HIS SHOULDER. ADDITIONAL INFORMATION STATED THE PHYSICIAN SUSPECTED THE CARDIAC RESYNCHRONIZATION THERAPY PACEMAKER (CRT-P) WAS SUTURED IN AN INADEQUATE POSITION. THE PHYSICIAN LATER DETERMINED THE CRT-P HAD MIGRATED FROM ITS ORIGINAL POSITION. THE PATIENT UNDERWENT A POCKET REVISION, IN WHICH THE CRT-P WAS REPOSITIONED. THE CRT-P REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Complaint, Ill-Defined; No Consequences Or Impact To Patient

  MAUDE report 7350464 ↗
• InjuryJan 16, 2018Low impedance; Ambient Noise Problem; Low impedance; Ambient Noise Problem

  BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS CARDIAC RESYNCHRONIZATION THERAPY PACEMAKER (CRT-P) EXHIBITED NOISE ON THE RIGHT VENTRICULAR (RV) CHANNEL. LOW OUT OF RANGE PACE IMPEDANCES OF LESS THAN 200 OHMS WERE ALSO OBSERVED. AT THIS TIME, THE RV LEAD HAS BEEN REPLACED AND THE CRT-P REMAINS IN SERVICE. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7193747 ↗
• InjuryJul 17, 2017High impedance; Ambient Noise Problem; High impedance; Ambient Noise Problem

  BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS CARDIAC RESYNCHRONIZATION THERAPY PACEMAKER (CRT-P) EXHIBITED HIGH RIGHT VENTRICULAR (RV) PACING IMPEDANCE MEASUREMENTS OF GREATER THAN 2000 OHMS AND NOISE. A SURGICAL REVISION WAS PERFORMED. THE PATIENT'S RV LEAD WAS NOT TESTED VIA THE PACING SYSTEM ANALYZER (PSA). THE RV LEAD WAS SURGICALLY ABANDONED AND REPLACED, AND WHEN THE NEW LEAD WAS CONNECTED TO THIS DEVICE, ALL MEASUREMENTS WERE WITHIN NORMAL LIMITS. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED. THE DEVICE REMAINS IN SERVICE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6717934 ↗
• InjuryApr 12, 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 EXPLANTED DUE TO INFECTION. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Unspecified Infection

  MAUDE report 6486545 ↗
• InjuryApr 12, 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 6485771 ↗
• InjuryOct 13, 2016Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS PRODUCT WAS PART OF A SYSTEM REVISION DUE TO INFECTION WITH SEPSIS. THERE WERE NO ADDITIONAL ADVERSE PATIENT EFFECTS REPORTED. THE PRODUCT WAS EXPLANTED.

  Patient problems: Sepsis; Unspecified Infection

  MAUDE report 6027552 ↗
• InjuryOct 13, 2016Over-Sensing; Pacing Problem; Over-Sensing; Pacing Problem

  BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS CARDIAC RESYNCHRONIZATION THERAPY PACEMAKER (CRT-P) EXHIBITED OVERSENSING AND PACING INHIBITION DURING AN ABLATION PROCEDURE. THE PATIENT WAS PACEMAKER DEPENDENT AND EXPERIENCED SYNCOPE. IT WAS NOTED THAT A MAGNET HAD NOT BEEN PLACED OVER THE DEVICE. A MAGNET WAS THEN PLACED OVER THE DEVICE AND THE PROCEDURE WAS COMPLETED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED. THIS PRODUCT REMAINS IMPLANTED AND IN SERVICE.

  Patient problems: Syncope

  MAUDE report 6025869 ↗
• InjuryApr 26, 2016Use of Device Problem; Adverse Event Without Identified Device or Use Problem; Use of Device Problem; Adverse Event Without Identified Device or Use Problem

  BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS PRODUCT WAS PART OF A SYSTEM REVISION DUE TO INFECTION AND EROSION. ALSO, THE PACEMAKER WAS USED AS TEMPORARY PACING DEVICE. THERE WERE NO ADDITIONAL ADVERSE PATIENT EFFECTS REPORTED. THE PRODUCT WAS EXPLANTED.

  Patient problems: Pocket Erosion; Unspecified Infection

  MAUDE report 5606817 ↗
• InjuryApr 25, 2016Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS PRODUCT WAS PART OF A SYSTEM REVISION DUE TO INFECTION. THERE WERE NO ADDITIONAL ADVERSE PATIENT EFFECTS REPORTED. THE PRODUCT WAS EXPLANTED.

  Patient problems: Unspecified Infection

  MAUDE report 5605143 ↗

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-0102-2026 · Aug 20, 2025 · Open, Classified
  Model Number U128, VALITUDE CRT-P EL MRI
• 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-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-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.