INGEVITY™ MRI 7736Recalls & reported problems

Summary

The FDA's MAUDE database contains 388 adverse event reports that list this exact device (DI 00802526523397), received between Jan 20, 2017 and Sep 25, 2026 — classified as 1 death, 300 injuries, 87 malfunctions.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (88 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 388 reports, in the reporter's own words as published by the FDA.

• InjurySep 25, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that this right atrial (RA) lead was explanted due to unknown cause. No lead replacement. No additional adverse patient effects were reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50903472 ↗
• InjurySep 18, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that this previously capped right atrial (RA) lead was part of a system revision due to infection. There was no additional adverse patient effects reported. The previously capped RA lead was explanted.

  Patient problems: Unspecified Infection

  MAUDE report 50817428 ↗
• InjurySep 14, 2026Insufficient Device Problem Information

  It was reported that this right atrial (RA) lead was surgically abandoned due to product performance anomaly and a new RA lead was placed. No additional adverse patient effects were reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50749886 ↗
• InjurySep 7, 2026High impedance

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50643757 ↗
• InjuryAug 11, 2026Device Dislodged or Dislocated

  It was reported that this right atrial (RA) lead exhibited dislodgment. This RA lead was revised and remains in service. No additional adverse patient effects were reported.Additional information indicated that an X ray was performed for evaluation. The patient remained stable.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50216528 ↗
• InjuryJul 15, 2026Insufficient Device Problem Information; High Capture Threshold

  IT WAS REPORTED THAT THIS BRADY LEAD WAS SURGICALLY EXPLANTED DUE TO UNKNOWN PRODUCT PERFORMANCE REASON. THIS BRADY LEAD WAS REPLACED WITH THE SAME MODEL. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25834098 ↗
• InjuryJul 3, 2026Under-Sensing

  IT WAS REPORTED THAT THIS RIGHT ATRIAL (RA) LEAD WAS AN EXPLANTED DUE TO UNDERSENSING. 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 25701273 ↗
• InjuryJul 1, 2026Adverse 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. THERE WERE NO ADDITIONAL ADVERSE PATIENT EFFECTS REPORTED. THIS RA LEAD WAS EXPLANTED.

  Patient problems: Unspecified Infection

  MAUDE report 25681134 ↗
• InjuryJun 29, 2026Insufficient Device Problem Information

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25650409 ↗
• InjuryMay 25, 2026Adverse 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. THERE WERE NO ADDITIONAL ADVERSE PATIENT EFFECTS REPORTED. THE RA LEAD WAS EXPLANTED.

  Patient problems: Unspecified Infection

  MAUDE report 25273118 ↗
• InjuryMay 22, 2026Device Dislodged or Dislocated

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25263039 ↗
• 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 25262920 ↗
• InjuryApr 29, 2026High impedance; Insufficient Device Problem Information; High Capture Threshold

  IT WAS REPORTED THAT THIS RIGHT ATRIAL (RA) LEAD WAS SURGICALLY ABANDONED DUE TO PRODUCT PERFORMANCE ANOMALY AND A NEW RA LEAD OF THE SAME MODEL WAS PLACED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25034509 ↗
• InjuryApr 20, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THIS RIGHT ATRIAL (RA) LEAD WAS PART OF A SYSTEM REVISION DUE TO POCKET EROSION WITH INFECTION. THERE WERE NO ADDITIONAL ADVERSE PATIENT EFFECTS REPORTED. THIS RA LEAD WAS SURGICALLY ABANDONED.

  Patient problems: Unspecified Infection

  MAUDE report 24927619 ↗
• MalfunctionApr 17, 2026Insufficient Device Problem Information

  IT WAS REPORTED THAT THIS BRADY LEAD WAS ATTEMPTED DUE TO UNKNOWN PRODUCT PERFORMANCE REASON. THIS BRADY LEAD WAS REPLACED AND NOT IMPLANTED. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24908392 ↗
• InjuryMar 26, 2026Difficult to Remove

  IT WAS REPORTED THAT THIS RIGHT ATRIAL (RA) LEAD WAS PART OF A SYSTEM REVISION DUE TO INFECTION WITH SEPSIS. THERE WAS ALSO VEGETATION ON THE LEAD. DURING THE EXTRACTION, THIS RA LEAD FELL APART AT THE TIP WHICH REQUIRED A SNARE TO EXTRACT THE ENTIRE LEAD. THIS RA LEAD WAS SUCCESSFULLY EXPLANTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Sepsis; Unspecified Infection

  MAUDE report 24701982 ↗
• InjuryMar 19, 2026Adverse 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. THERE WERE NO ADDITIONAL ADVERSE PATIENT EFFECTS REPORTED. THIS RA LEAD WAS EXPLANTED.

  Patient problems: Unspecified Infection

  MAUDE report 24646102 ↗
• InjuryMar 17, 2026Failure to Capture

  IT WAS REPORTED THAT THIS RIGHT ATRIAL (RA) LEAD EXHIBITED LOSS OF CAPTURE (LOC) AND WAS SUBSEQUENTLY SURGICALLY ABANDONED. A NEW RA LEAD WAS IMPLANTED AS A REPLACEMENT SUCCESSFULLY. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24619660 ↗
• InjuryMar 10, 2026Adverse 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. THERE WERE NO ADDITIONAL ADVERSE PATIENT EFFECTS REPORTED. THIS RA LEAD WAS EXPLANTED.

  Patient problems: Unspecified Infection

  MAUDE report 24557897 ↗
• InjuryFeb 16, 2026Adverse 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. THERE WERE NO ADDITIONAL ADVERSE PATIENT EFFECTS REPORTED. THE RA LEAD WAS EXPLANTED.

  Patient problems: Unspecified Infection

  MAUDE report 24349880 ↗
• InjuryFeb 2, 2026Adverse Event Without Identified Device or Use Problem

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

  Patient problems: Unspecified Infection

  MAUDE report 24242033 ↗
• InjuryFeb 2, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THIS RIGHT ATRIAL (RA) LEAD WAS SURGICALLY ABANDONED DUE TO UNKNOWN REASON. A NEW RA LEAD WITH A DIFFERENT MODEL WAS PLACED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24233745 ↗
• InjuryJan 27, 2026Insufficient Device Problem Information

  IT WAS REPORTED THAT THIS RIGHT ATRIAL (RA) LEAD WAS EXPLANTED DUE TO A NONSPECIFIC PRODUCT PERFORMANCE ANOMALY. A NEW LV LEAD WAS IMPLANTED. THIS PRODUCT HAS NOT BEEN RETURNED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24192277 ↗
• InjuryJan 27, 2026Signal Artifact/Noise; Fracture; High impedance; Over-Sensing

  IT WAS REPORTED THAT THIS RIGHT ATRIAL (RA) LEAD EXHIBITED OVERSENSING OF NOISY SIGNALS AND HIGH OUT OF RANGE IMPEDANCE MEASUREMENTS. THE LEAD SAFETY TRIGGER SWITCH HAD BEEN TRIGGERED THREE MONTHS BACK, WHICH CAUSE THE LEAD TO SWITCH FROM BIPOLAR TO UNIPOLAR. THE RA LEAD WAS REPORTED TO HAVE A FRACTURE. TECHNICAL SERVICES (TS) WAS CONSULTED AND DISCUSSED STORED DATA AS WELL AS AVAILABLE PROGRAMMING OPTIONS. THIS DEVICE REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED. AT A LATER DATE, THIS RIGHT ATRIAL (RA) LEAD WAS CAPPED AND SURGICALLY ABANDONED. A NEW DEVICE WAS IMPLANTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24189262 ↗
• InjuryJan 15, 2026Adverse Event Without Identified Device or Use Problem

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

  Patient problems: Unspecified Infection

  MAUDE report 24082296 ↗

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-0081-2026 · Aug 20, 2025 · Open, Classified
  ACCOLADE SR SL MRI (Model L310)
• Z-0097-2026 · Aug 20, 2025 · Open, Classified
  Model Number L131, ESSENTIO DR EL MRI Pacemaker
• 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-0095-2026 · Aug 20, 2025 · Open, Classified
  Model Number L111, ESSENTIO DR SL MRI Pacemaker
• Z-0091-2026 · Aug 20, 2025 · Open, Classified
  Model Number L231, PROPONENT DR EL MRI Pacemaker
• Z-0088-2026 · Aug 20, 2025 · Open, Classified
  Model Number L210 PROPONENT SR SL Pacemaker
• Z-0082-2026 · Aug 20, 2025 · Open, Classified
  ACCOLADE DR SL MRI (Model L311)
• 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-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-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-1998-2021 · Jun 3, 2021 · Open, Classified
  Essentio pacemaker, Models: a) L100 b) L101 c) L110 d) L111 e) L121 f) L131
• Z-2017-2021 · Jun 3, 2021 · Open, Classified
  VITALIO DR EL (pacemaker), Model Numbers: a) J274 b) J277 c) K274 (added 7/15/2021) d) K277 (added 7/15/2021) e) K284 (added 7/15/2021) f) K287 (added 7/15/2021)

…and 13 more.