INGEVITY™ MRI 7732Recalls & reported problems

Summary

The FDA's MAUDE database contains 466 adverse event reports that list this exact device (DI 00802526523335), received between Jan 20, 2017 and Jul 9, 2026 — classified as 3 deaths, 356 injuries, 107 malfunctions.

The most frequently reported specific device problem is “High impedance” (146 reports).

28 other recalls cover devices cleared under the same FDA submission (P150012); 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 466 reports, in the reporter's own words as published by the FDA.

• InjuryJul 9, 2026Failure to Capture; High Capture Threshold

  IT WAS REPORTED THAT THIS RIGHT VENTRICULAR (RV) LEAD HAD ELEVATED PACING THRESHOLDS AND HIGH OUTPUT SETTINGS. THE PHYSICIAN PLANS TO PERFORM A LEAD REVISION AND REPLACEMENT OF THE RV LEAD. THE LEAD REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED. ADDITIONAL INFORMATION IS RECEIVED INDICATING THAT THIS LEAD WAS EXPLANTED. A NEW LEAD WAS REPLACED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25764049 ↗
• MalfunctionJul 6, 2026High impedance

  IT WAS REPORTED THAT THIS RIGHT VENTRICULAR (RV) LEAD EXHIBITED HIGH OUT OF RANGE PACE IMPEDANCE MEASUREMENTS ABOVE 3000 OHMS. TECHNICAL SERVICES (TS) WAS CONSULTED AND UPON REVIEW THE IMPEDANCE TREND SHOW A GRADUAL RISE. THE PHYSICIAN OPTED TO PERFORM PROGRAMMING ENHANCEMENTS. NO ADVERSE PATIENT EFFECTS WERE REPORTED. THIS LEAD REMAINS IN SERVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25721848 ↗
• InjuryJun 22, 2026Device Contamination with Body Fluid

  IT WAS REPORTED THAT THIS RIGHT VENTRICULAR (RV) LEAD CAUSED SEVERE TRICUSPID REGURGITATION DUE TO LEAFLET ENTRAPMENT. DURING LEAD REMOVAL, GENTLE TRACTION REVEALED ADHESIONS WITHIN THE CENTRAL VENOUS SYSTEM; THESE WERE SUCCESSFULLY TREATED USING LASER, ALLOWING FOR COMPLETE EXPLANTATION. A SMALL AMOUNT OF MYOCARDIUM WAS OBSERVED ON THE LEAD, TOGETHER WITH FIBROUS TISSUE ALONG THE LEAD BODY. THE PATIENT REMAINED HEMODYNAMICALLY STABLE THROUGHOUT THE PROCEDURE AND A TRANSESOPHAGEAL ECHOCARDIOGRAPHY DEMONSTRATED MODERATE TRICUSPID REGURGITATION WITH NO EVIDENCE OF PERICARDIAL EFFUSION. A LEADLESS PACEMAKER WAS SUCCESSFULLY IMPLANTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED. THIS PRODUCT WAS RECEIVED FOR ANALYSIS.

  Patient problems: Adhesion(s); Valvular Insufficiency/ Regurgitation

  MAUDE report 25587825 ↗
• InjuryJun 19, 2026High impedance; Insufficient Device Problem Information

  IT WAS REPORTED THAT THIS RIGHT VENTRICULAR (RV) LEAD WAS SURGICALLY ABANDONED DUE TO UNKNOWN PRODUCT PERFORMANCE ANOMALY. A NEW LEAD WITH DIFFERENT MODEL WAS IMPLANTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25563863 ↗
• InjuryJun 9, 2026Failure to Capture; Pacing Problem; Device Dislodged or Dislocated

  IT WAS REPORTED THAT DURING A ROUTINE FOLLOW UP; THIS RIGHT VENTRICULAR (RV) LEAD WAS SUSPECTED TO BE DISLODGED. IT WAS ALSO NOTED THIS RV LEAD EXHIBITED LOSS OF CAPTURE (LOC) AND PACING INHIBITION. THE PACING INHIBITION LASTED ONE SECOND. THE PATIENT WAS SENT FOR AN X-RAY, WHICH CONFIRMED THE LEAD WAS DISLODGED. A LEAD REVISION PROCEDURE WAS PERFORMED, AND A NEW RV LEAD WAS IMPLANTED TO RESOLVE THE PACING INHIBITION. THIS RV LEAD WAS SURGICALLY ABANDONED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Bradycardia

  MAUDE report 25446924 ↗
• MalfunctionMay 22, 2026Failure to Capture

  IT WAS REPORTED THAT THE HEALTH CARE PROFESSIONAL (HCP) REQUESTED A REVIEW OF THE PRESENTING ELECTROGRAM (EGM) FOR THIS PACEMAKER, RIGHT VENTRICULAR (RV) AND RIGHT ATRIAL (RA) LEADS. TECHNICAL SERVICES (TS) REVIEWED AND NOTED THAT RHYTHM SEEMS TO BE ATRIAL TO VENTRICLE DISSOCIATION DUE TO A SLOWED SINUS NODE OR AN ACCELERATED JUNCTIONAL RATE. TS STATED THIS WAS CAUSING FUNCTIONAL NON CAPTURE ON BOTH THE RIGHT ATRIAL (RA) AND RIGHT VENTRICULAR (RV) CHANNELS. THIS PACEMAKER, RV AND RA LEAD REMAIN IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25262932 ↗
• InjuryMay 22, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THIS RIGHT VENTRICULAR (RV) LEAD WAS PART OF A SYSTEM REVISION DUE TO INFECTION. THERE WERE NO ADDITIONAL ADVERSE PATIENT EFFECTS REPORTED. THE RV LEAD REMAINS IN SERVICE.

  Patient problems: Unspecified Infection

  MAUDE report 25256636 ↗
• InjuryMay 21, 2026Fracture

  IT WAS REPORTED THAT THIS RIGHT VENTRICULAR (RV) LEAD WAS SURGICALLY ABANDONED DUE TO FRACTURE. NO NEW LEAD WAS IMPLANTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25246674 ↗
• MalfunctionMay 18, 2026Failure to Capture; High Capture Threshold

  IT WAS REPORTED THAT THIS RIGHT VENTRICULAR (RV) LEAD SHOWED A SUDDEN INCREASE IN PACING THRESHOLD VALUES. THE OUTPUT IS PROGRAMMED TO TREND BUT AT A RV AUTOMATIC THRESHOLD TEST, LOSS OF CAPTURE WAS OBSERVED AT A LOWER THAN PROGRAMMED OUTPUT VALUE. THE PATIENT IS LOWLY RV PACED; THEREFORE HEALTH CARE PROFESSIONAL WILL CONTINUE MONITORING THE PATIENT. THE RV LEAD REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25197884 ↗
• MalfunctionApr 27, 2026High impedance

  IT WAS REPORTED THAT THIS PACEMAKER SYSTEM TRIGGERED A LEAD SAFETY SWITCH (LSS) DUE TO HIGH OUT OF RANGE PACING IMPEDANCE MEASUREMENTS OF 2001 OHMS IN THE RIGHT VENTRICULAR (RV) CHANNEL. THE PATIENT CONTACTED TECHNICAL SERVICES (TS) SINCE THE DEVICE RECORDED AN ALERT. THIS RV LEAD REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25009931 ↗
• InjuryApr 27, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THIS RIGHT VENTRICULAR (RV) LEAD WAS EXPLANTED DUE TO AN INFECTION. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED. THIS RV LEAD HAS BEEN RETURNED FOR ANALYSIS; HOWEVER, RESULTS OF INVESTIGATION ARE NOT AVAILABLE AT TIME OF SUBMISSION OF THIS REPORT. A SUPPLEMENTAL REPORT WILL BE SUBMITTED ONCE RESULTS OF INVESTIGATION BECOME AVAILABLE.

  Patient problems: Unspecified Infection

  MAUDE report 25001071 ↗
• InjuryApr 17, 2026Insufficient Device Problem Information

  IT WAS REPORTED THAT THIS RIGHT VENTRICULAR (RV) LEAD WAS SURGICALLY ABANDONED DUE TO UNKNOWN PRODUCT PERFORMANCE ANOMALY. A NEW LEAD WITH DIFFERENT MODEL WAS IMPLANTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24913679 ↗
• InjuryApr 13, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THIS RIGHT VENTRICULAR (RV) LEAD WAS PART OF A SYSTEM REVISION DUE TO INFECTION. THERE WERE NO ADDITIONAL ADVERSE PATIENT EFFECTS REPORTED. THIS RV LEAD WAS EXPLANTED.

  Patient problems: Unspecified Infection

  MAUDE report 24867490 ↗
• MalfunctionApr 6, 2026Failure to Capture; Failure to Read Input Signal; Under-Sensing

  IT WAS REPORTED THAT THIS SYSTEM WITH A PACEMAKER AND RIGHT VENTRICULAR (RV) LEAD SHOWED PREMATURE VENTRICULAR CONTRACTIONS BLANKED BY ATRIAL PACING. AFTERWARDS, LOSS OF CAPTURE (LOC) IS OBSERVED AT THE RV CHANNEL, WHICH TRIGGERS A VENTRICULAR PACE BACK UP. ALSO, OTHER VENTRICULAR PACING HAS A FUSION MARKER AND SHOWS A SMALL MORPHOLOGY. PROGRAMMING OPTION FOR OPTIMIZING VENTRICULAR SENSING WINDOW WAS SUGGESTED FOR THIS PACEMAKER AND RV LEAD SYSTEM THAT REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24796096 ↗
• InjuryMar 19, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THIS RIGHT VENTRICULAR (RV) LEAD WAS PART OF A SYSTEM REVISION DUE TO INFECTION. THERE WERE NO ADDITIONAL ADVERSE PATIENT EFFECTS REPORTED. THIS RV LEAD WAS EXPLANTED.

  Patient problems: Unspecified Infection

  MAUDE report 24646098 ↗
• InjuryFeb 16, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THIS RIGHT VENTRICULAR (RV) LEAD WAS PART OF A SYSTEM REVISION DUE TO INFECTION. THERE WERE NO ADDITIONAL ADVERSE PATIENT EFFECTS REPORTED. THE RV LEAD WAS EXPLANTED.

  Patient problems: Unspecified Infection

  MAUDE report 24349900 ↗
• MalfunctionJan 27, 2026Fracture

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED LEAD FRACTURED. BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) STATED THAT THE SYSTEM IS NO LONGER MAGNETIC RESONANCE IMAGING (MRI) CONDITIONAL. THIS LEAD REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24194530 ↗
• MalfunctionJan 16, 2026Insufficient Device Problem Information

  IT WAS REPORTED THAT PATIENT WITH THIS RIGHT VENTRICULAR (RV) LEAD FELT THE LEAD DUE TO DEVICE HAS MOVED. BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) REFERRED THE PATIENT TO CLINIC. THIS LEAD REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24104924 ↗
• MalfunctionJan 16, 2026High impedance

  IT WAS REPORTED THAT THIS RIGHT VENTRICULAR (RV) LEAD TRIGGERED A LEAD SAFETY SWITCH (LSS) DUE TO HIGH OUT OF RANGE PACING IMPEDANCE MEASUREMENTS OF 2146OHMS. TECHNICAL SERVICES (TS) WAS CONTACTED AND ALSO NOTED SPIKES IN THE IMPEDANCE MEASUREMENTS. FOLLOW UP WITH THE PHYSICIAN WAS RECOMMENDED. THIS RV LEAD REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24099940 ↗
• InjuryJan 15, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THIS PREVIOUSLY CAPPED RIGHT VENTRICULAR (RV) LEAD WAS PART OF A SYSTEM REVISION DUE TO INFECTION. THERE WERE NO ADDITIONAL ADVERSE PATIENT EFFECTS REPORTED. THIS PREVIOUSLY CAPPED RV LEAD WAS EXPLANTED.

  Patient problems: Unspecified Infection

  MAUDE report 24082292 ↗
• InjuryJan 13, 2026Signal Artifact/Noise; Fracture; High impedance

  IT WAS REPORTED THAT DURING A ROUTINE CHECKUP, THIS RIGHT VENTRICULAR (RV) LEAD EXHIBITED HIGH OUT OF RANGE PACING IMPEDANCE MEASUREMENTS WHICH TRIGGERED A LEAD SAFETY SWITCH (LSS) TO UNIPOLAR PACING. THE PATIENT WAS SENT TO THE EMERGENCY ROOM (ER) AND THERE WAS NOISE PRESENT ON THE RV LEAD IN BOTH UNIPOLAR AND BIPOLAR PACING. ADDITIONALLY, THE LEAD WAS BELIEVED TO BE FRACTURED. THIS RV LEAD WAS SURGICALLY ABANDONED, AND NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24063347 ↗
• InjuryJan 2, 2026High impedance; Insufficient Device Problem Information

  IT WAS REPORTED THAT THIS RIGHT VENTRICULAR (RV) LEAD WAS SURGICALLY ABANDONED DUE TO UNKNOWN PRODUCT PERFORMANCE REASON. THIS RV LEAD WAS REPLACED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23941927 ↗
• MalfunctionDec 31, 2025High impedance; High impedance

  IT WAS REPORTED THAT DURING A REQUEST TO PROGRAM THIS PACEMAKER SYSTEM INTO MAGNETIC RESONANCE IMAGING (MRI) PROTECTION MODE IT WAS DISCOVERED THAT THERE WAS PACING IMPEDANCE MEASUREMENTS OUT OF RANGE ON THE RIGHT ATRIAL (RA) AND RIGHT VENTRICULAR (RV) LEADS. THE SCAN WAS THEN NOT COMPLETE AS THE SYSTEM WAS DEEMED NOT CONDITIONAL. TECHNICAL SERVICES (TS) PROVIDED TROUBLESHOOTING OPTIONS. THIS LEAD REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23936309 ↗
• InjuryDec 29, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THIS RIGHT ATRIAL (RA) LEAD WAS PART OF A SYSTEM REVISION DUE TO INFECTION. THE PATIENT WAS TREATED WITH INTRAVENOUS ANTIBIOTICS. THERE WERE NO ADDITIONAL ADVERSE PATIENT EFFECTS REPORTED. THE RA LEAD WAS EXPLANTED.

  Patient problems: Unspecified Infection

  MAUDE report 23905355 ↗
• InjuryDec 24, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THIS BRADY LEAD WAS NOT SUCCESSFULLY IMPLANTED DUE TO UNKNOWN PRODUCT PERFORMANCE ANOMALY AND A NEW LEAD WAS IMPLANTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23887970 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under P150012. One submission often covers many models, so check the product and lot details in each record.

• Z-1770-2026 · Mar 19, 2026 · Open, Classified
  Boston Scientific Pacemaker, Implantable Pulse Generator, Pacemaker (non- Cardiac Re-Synchronization Therapy) labeled as: 1. ESSENTIO SR SL, Model Number L100; 2. ESSENTIO DR SL
• Z-0094-2026 · Aug 20, 2025 · Open, Classified
  Model Number L110, ESSENTIO SR SL MRI Pacemaker
• Z-0082-2026 · Aug 20, 2025 · Open, Classified
  ACCOLADE DR SL MRI (Model L311)
• Z-0097-2026 · Aug 20, 2025 · Open, Classified
  Model Number L131, ESSENTIO DR EL MRI Pacemaker
• Z-0095-2026 · Aug 20, 2025 · Open, Classified
  Model Number L111, ESSENTIO DR SL MRI Pacemaker
• Z-0081-2026 · Aug 20, 2025 · Open, Classified
  ACCOLADE SR SL MRI (Model L310)
• Z-0088-2026 · Aug 20, 2025 · Open, Classified
  Model Number L210 PROPONENT SR SL Pacemaker
• Z-0091-2026 · Aug 20, 2025 · Open, Classified
  Model Number L231, PROPONENT DR EL MRI Pacemaker
• Z-0084-2026 · Aug 20, 2025 · Open, Classified
  ACCOLADE DR EL MRI (Model L331)
• Z-0089-2026 · Aug 20, 2025 · Open, Classified
  Model Number L211 PROPONENT DR SL MRI Pacemaker
• Z-0824-2025 · Dec 12, 2024 · Open, Classified
  ESSENTIO DR Pacemaker, SL (Model Number L101, SL MRI (Model Number L111), EL (Model Number L121), and EL MRI (Model Number L131)
• Z-0823-2025 · Dec 12, 2024 · Open, Classified
  PROPONENT DR Pacemaker, SL (Model Number L201), (VDD) SL (Model Number L209), SL MRI (Model Number L211), EL (Model Number L221), and EL MRI (Model Number L231).
• Z-0822-2025 · Dec 12, 2024 · Open, Classified
  ACCOLADE DR Pacemaker, SL (Model Number L301), SL MRI (Model Number L311), EL (Model Number L321), and EL MRI (Model Number L331)
• Z-1999-2021 · Jun 3, 2021 · Open, Classified
  Proponent pacemaker, Models: a) L200 b) L201 c) L209 d) L210 e) L211 f) L221 g) L231
• Z-1998-2021 · Jun 3, 2021 · Open, Classified
  Essentio pacemaker, Models: a) L100 b) L101 c) L110 d) L111 e) L121 f) L131

…and 13 more.