INGEVITY™ MRI 7731Recalls & reported problems

Summary

The FDA's MAUDE database contains 386 adverse event reports that list this exact device (DI 00802526523304), received between Mar 29, 2017 and Sep 28, 2026 — classified as 5 deaths, 310 injuries, 71 malfunctions.

The most frequently reported specific device problem is “High impedance” (105 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 386 reports, in the reporter's own words as published by the FDA.

• InjurySep 28, 2026Fracture; High Capture Threshold

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50918967 ↗
• InjurySep 25, 2026Failure to Capture; High impedance; High Capture Threshold

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50902571 ↗
• MalfunctionSep 16, 2026High impedance

  It was reported that this pacemaker system triggered a lead safety switch (LSS) due to high out of range pacing impedance measurements greater than 3000 Ohms in the right ventricular (RV) channel. Technical Services (TS) was contacted and recommended follow up to review lead performance. This RV lead remains in service. No adverse patient effects were reported.Additional information received detailed that this RV lead was subsequently explanted and successfully replaced. No additional adverse patient effects were reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50796947 ↗
• InjurySep 9, 2026High impedance; Material Integrity Problem; 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 with the same model. No additional adverse patient effects were reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50690109 ↗
• MalfunctionSep 8, 2026Signal Artifact/Noise; Over-Sensing; Impedance Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50674033 ↗
• InjuryAug 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 was no additional adverse patient effects reported. The RV lead was explanted.

  Patient problems: Unspecified Infection

  MAUDE report 50264279 ↗
• MalfunctionAug 14, 2026High impedance; Over-Sensing

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50248285 ↗
• InjuryAug 11, 2026Failure to Capture; Fracture; High impedance

  It was reported that during a generator replacement procedure, this right ventricular (RV) lead was determined to be fractured. Subsequent testing was performed, and loss of capture (LOC) was observed. Additionally, pacing impedance measurements were found to be high and out of range. As a result, the RV lead was capped and a new lead was implanted. No additional adverse patient effects were reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50204404 ↗
• InjuryAug 4, 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 erosion and infection. The patient was so thin thus, the system eroded through the skin. There were no additional adverse patient effects reported. The RV lead was explanted.

  Patient problems: Erosion; Unspecified Infection

  MAUDE report 50132292 ↗
• InjuryJul 10, 2026Insufficient 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 25786528 ↗
• MalfunctionJul 2, 2026High impedance; Off-Label Use

  IT WAS REPORTED THAT THE PATIENT WITH THIS PACEMAKER DEVICE SYSTEM WAS SCHEDULED TO UNDERGO A MAGNETIC RESONANCE IMAGING (MRI) PROCEDURE. TECHNICAL SERVICES (TS) DISCUSSED THAT THIS RIGHT VENTRICULAR (RV) LEAD EXHIBITED HIGH OUT OF RANGE PACE IMPEDANCE MEASUREMENTS, GREATER THAN 3000 OHMS. DUE TO THIS, THE MRI IS CONSIDERED OFF LABEL. FURTHER INFORMATION REGARDING THE OUTCOME OF THE MRI IS BEING REQUESTED. REPROGRAMMING OPTIONS WERE RECOMMENDED. NO ADVERSE PATIENT EFFECTS WERE REPORTED. THIS LEAD REMAINS IN SERVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25690779 ↗
• MalfunctionJun 26, 2026Signal Artifact/Noise; Failure to Capture; High impedance; Pacing Problem

  IT WAS REPORTED THAT THIS RIGHT VENTRICULAR (RV) LEAD EXHIBITED NOISE THAT PREVENTED ATRIAL PACING. TECHNICAL SERVICES (TS) REVIEWED THE DATA AND DISCUSSED THIS WAS NORMAL DEVICE FUNCTION. UPON REVIEW, TS ALSO NOTED PACING INHIBITION FOR LONGER THAN TWO SECONDS. TS ALSO MENTIONED THE RV LEAD WAS SET TO UNIPOLAR PACING AND SENSING AFTER A SUDDEN INCREASE TO AN OUT-OF-RANGE PACING IMPEDANCE MEASUREMENT. IT WAS ALSO NOTED THIS RV LEAD EXHIBITED LOSS OF CAPTURE (LOC) AND THE LEAD WOULD BE REVISED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED. THIS RV LEAD REMAINS IN SERVICE.

  Patient problems: Asystole

  MAUDE report 25638397 ↗
• InjuryJun 15, 2026High impedance

  IT WAS REPORTED THAT THIS RIGHT VENTRICULAR (RV) LEAD EXHIBITED HIGH OUT OF RANGE PACING IMPEDANCE MEASUREMENTS GREATER THAN 2,000 OHMS. THIS RESULTED IN A LEAD SAFETY SWITCH AND UNIPOLAR CONFIGURATION. HIGH RV PACING IMPENDENCE MEASUREMENTS WERE CONFIRMED VIA DEVICE INTERROGATION. THIS RV LEAD WAS SURGICALLY ABANDONED. A NEW RV LEAD WAS IMPLANTED TO COMPLETE THIS PROCEDURE. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25503432 ↗
• InjuryJun 1, 2026Insufficient Device Problem Information

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25350629 ↗
• InjuryMay 22, 2026High impedance; High Capture Threshold

  IT WAS REPORTED THAT THIS RIGHT VENTRICULAR (RV) LEAD EXHIBITED A GRADUAL RISE OF PACING IMPEDANCES FROM 500 OHMS TO 1400 OHMS, REMAINING WITHIN NORMAL LIMITS. TECHNICAL SERVICES (TS) NOTED AN INCREASE IN HIGH CAPTURE THRESHOLD VALUES. TS RECOMMENDED PROGRAMMING ENHANCEMENTS. ADDITIONALLY, IT WAS MENTIONED THAT AN ECHOCARDIOGRAM AND FURTHER MONITORING WOULD BE PERFORMED. THIS RV LEAD WAS EXPLANTED AND REPLACED AND HAS NOT BEEN RETURNED FOR ANALYSIS. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25261795 ↗
• InjuryMay 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. THE RV LEAD WAS EXPLANTED.

  Patient problems: Unspecified Infection

  MAUDE report 25215311 ↗
• MalfunctionMay 8, 2026Signal Artifact/Noise; High impedance; Over-Sensing

  IT WAS REPORTED THAT THIS RIGHT VENTRICULAR (RV) LEAD TRIGGERED A LEAD SAFETY SWITCH (LSS) DUE TO HIGH OUT OF RANGE PACE IMPEDANCE MEASUREMENTS. ADDITIONALLY, OVERSENSED NOISY SIGNALS WERE OBSERVED ON THE STORED ELECTROGRAM FROM A RIGHT VENTRICULAR AUTOMATIC THRESHOLD TEST. THE LOCAL FIELD REPRESENTATIVE WAS NOTIFIED AND CONTACTED THE CLINIC AND LEARNED THAT THE PATIENT IS FOLLOWING UP WITH ELECTROPHYSIOLOGY. NO PAUSE IN PACING WAS OBSERVED, AND NO ADVERSE PATIENT EFFECTS WERE REPORTED. THIS RV LEAD REMAINS IN SERVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25129604 ↗
• InjuryApr 7, 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 CAPPED.

  Patient problems: Unspecified Infection

  MAUDE report 24801732 ↗
• MalfunctionApr 3, 2026High impedance

  IT WAS REPORTED THAT THIS RIGHT VENTRICULAR (RV) LEAD TRIGGERED A LEAD SAFETY SWITCH (LSS) DUE TO HIGH OUT OF RANGE PACING IMPEDANCES WITH AN APPROXIMATE VALUE OF 2600 OHMS. A GRADUAL RISE IN IMPEDANCES WAS OBSERVED. TECHNICAL SERVICES (TS) WAS CONSULTED AND PROVIDED REPROGRAMMING OPTIONS. THIS RV LEAD REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24778899 ↗
• InjuryMar 25, 2026Signal Artifact/Noise; Failure to Capture; Impedance Problem; Insufficient Device Problem Information

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24689559 ↗
• MalfunctionMar 20, 2026High impedance

  IT WAS REPORTED THAT THIS PACEMAKER SYSTEM TRIGGERED A LEAD SAFETY SWITCH (LSS) DUE TO HIGH OUT OF RANGE RIGHT VENTRICULAR (RV) LEAD PACING IMPEDANCE MEASUREMENT GREATER THAN 3000 OHMS. TECHNICAL SERVICES (TS) WAS CONSULTED AND RECOMMENDED FURTHER CLINICAL EVALUATION. THIS RV LEAD REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24650205 ↗
• InjuryMar 19, 2026Fracture; Off-Label Use; Device Contamination with Body Fluid

  IT WAS REPORTED THAT DURING A GENERATOR CHANGE PROCEDURE, IT WAS NOTED THAT THE RIGHT VENTRICULAR (RV) LEAD SHOWED A MINOR FRACTURE IN THE INSULATION NEAR THE TERMINAL BOOT, WITH EVIDENCE OF OLD BLOOD PRESENT. DESPITE THIS FINDING, RV LEAD PERFORMANCE REMAINED INTACT, DEMONSTRATING STABLE MEASUREMENTS. MANIPULATION OF THE RV LEAD DID NOT PRODUCE ANY NOISE OR ABNORMAL SIGNALS. MEDICAL ADHESIVE (MA) WAS APPLIED TO REPAIR THE INSULATION, AND A SLEEVE WAS PLACED FOR REINFORCEMENT. THE DEVICE CONTINUES TO FUNCTION APPROPRIATELY AND REMAINS IN SERVICE, AND NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE NOTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24639529 ↗
• InjuryJan 21, 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 24135313 ↗
• InjuryJan 8, 2026Device Dislodged or Dislocated

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24012494 ↗
• MalfunctionDec 31, 2025High impedance; High Capture Threshold; High impedance; High Capture Threshold

  IT WAS REPORTED THAT THIS RIGHT VENTRICULAR (RV) LEAD EXHIBITED PACING IMPEDANCE MEASUREMENTS HIGH OUT OF RANGE AS WELL AS HIGH CAPTURE THRESHOLDS. TECHNICAL SERVICES (TS) REVIEWED AND NOTED A GRADUAL RISE ON THE IMPEDANCE MEASUREMENTS. FURTHER LEAD EVALUATION WAS RECOMMENDED. THIS LEAD REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23932121 ↗

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-0091-2026 · Aug 20, 2025 · Open, Classified
  Model Number L231, PROPONENT DR EL MRI Pacemaker
• Z-0097-2026 · Aug 20, 2025 · Open, Classified
  Model Number L131, ESSENTIO DR EL MRI Pacemaker
• Z-0088-2026 · Aug 20, 2025 · Open, Classified
  Model Number L210 PROPONENT SR SL Pacemaker
• Z-0095-2026 · Aug 20, 2025 · Open, Classified
  Model Number L111, ESSENTIO DR SL MRI Pacemaker
• Z-0082-2026 · Aug 20, 2025 · Open, Classified
  ACCOLADE DR SL MRI (Model L311)
• Z-0081-2026 · Aug 20, 2025 · Open, Classified
  ACCOLADE SR SL MRI (Model L310)
• Z-0094-2026 · Aug 20, 2025 · Open, Classified
  Model Number L110, ESSENTIO SR SL MRI Pacemaker
• Z-0089-2026 · Aug 20, 2025 · Open, Classified
  Model Number L211 PROPONENT DR SL MRI Pacemaker
• Z-0084-2026 · Aug 20, 2025 · Open, Classified
  ACCOLADE DR EL MRI (Model L331)
• 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-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-1998-2021 · Jun 3, 2021 · Open, Classified
  Essentio pacemaker, Models: a) L100 b) L101 c) L110 d) L111 e) L121 f) L131
• Z-2000-2021 · Jun 3, 2021 · Open, Classified
  Accolade pacemaker, Models: a) L300 b) L301 c) L310 d) L311 e) L321 f) L331

…and 13 more.