INGEVITY™ MRI 7735Recalls & reported problems

Summary

The FDA's MAUDE database contains 263 adverse event reports that list this exact device (DI 00802526523366), received between Apr 10, 2017 and Aug 18, 2026 — classified as 2 deaths, 229 injuries, 32 malfunctions.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (61 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 263 reports, in the reporter's own words as published by the FDA.

• InjuryAug 18, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that this implantable lead was part of the system revision due to infection. No adverse patient effects were reported. The implantable lead was explanted.

  Patient problems: Unspecified Infection

  MAUDE report 50295711 ↗
• InjuryJul 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. THE RA LEAD WAS EXPLANTED.

  Patient problems: Unspecified Infection

  MAUDE report 25786550 ↗
• InjuryApr 20, 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 24931503 ↗
• InjuryApr 7, 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 REMAINS IN SERVICE

  Patient problems: Unspecified Infection

  MAUDE report 24801730 ↗
• InjuryMar 8, 2026Failure to Capture; Device Dislodged or Dislocated; Insufficient Device Problem Information; High Capture Threshold

  IT WAS REPORTED THAT THIS RIGHT ATRIAL (RA) LEAD WAS EXPLANTED DUE TO UNKNOWN PRODUCT PERFORMANCE ANOMALY. A NEW LEAD WITH DIFFERENT MODEL WAS IMPLANTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED. ADDITIONAL INFORMATION INDICATED THAT THIS RA LEAD HAD EXHIBITED HIGH PACING THRESHOLD DUE TO SLACK ON THE LEAD COMING OUT. ALSO, THE INCREASED THRESHOLD ROSE TO NO CAPTURE. THERE WERE NO ASSOCIATED PATIENT SYMPTOMS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24542074 ↗
• MalfunctionMar 4, 2026Fracture; High impedance; Over-Sensing

  IT WAS REPORTED THAT THIS RIGHT ATRIAL (RA) LEAD EXHIBITED PACING IMPEDANCE HIGH OUT OF RANGE. THE LEAD ALSO PRESENTED FARFIELD OVERSENSING, WHICH LED TO ONE INAPPROPRIATE ATRIAL TACHY RESPONSE (ATR) EVENT. THE LEAD IS CAPTURING CORRECTLY. THE RA WAS REPORTED TO HAVE FRACTURED. THE LEAD REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24509108 ↗
• InjuryFeb 4, 2026Failure to Capture

  IT WAS REPORTED THAT THIS RIGHT ATRIAL (RA) LEAD WAS SURGICALLY ABANDONED DUE TO NO CAPTURE AT MAX OUTPUT. A NEW LEAD WITH THE DIFFERENT MODEL WAS IMPLANTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24257079 ↗
• InjuryJan 23, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THIS IMPLANTABLE LEAD WAS PART OF THE SYSTEM REVISION DUE TO INFECTION AND SEPSIS. REPORTEDLY, THE PATIENT HAD AN INFECTION IN THE BLOODSTREAM THUS AFFECTING THE IMPLANTABLE PRODUCTS AND THEN OPT TO REMOVE THE SYSTEM. NO ADVERSE PATIENT EFFECTS WERE REPORTED. THE IMPLANTABLE LEAD WAS SURGICALLY ABANDONED. DUE TO THE LIMITED INFORMATION RECEIVED, FURTHER FOLLOW-UP TO OBTAIN RELATED DETAILS WAS NOT POSSIBLE.

  Patient problems: Sepsis; Unspecified Infection

  MAUDE report 24167449 ↗
• InjuryDec 31, 2025Fracture; Material Integrity Problem; Fracture; Material Integrity Problem

  IT WAS REPORTED RIGHT ATRIAL (RA) LEAD WAS EXPLANTED DUE TO FRACTURED. A NEW LEAD WAS IMPLANTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23935303 ↗
• InjuryDec 28, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THIS IMPLANTABLE LEAD WAS PART OF THE SYSTEM REVISION DUE TO INFECTION. NO ADVERSE PATIENT EFFECTS WERE REPORTED. THE IMPLANTABLE LEAD WAS EXPLANTED.

  Patient problems: Unspecified Infection

  MAUDE report 23904050 ↗
• MalfunctionDec 22, 2025High impedance; High impedance

  IT WAS REPORTED THAT THIS RIGHT ATRIAL (RA) LEAD EXHIBITED OUT OF RANGE PACING IMPEDANCE MEASUREMENTS. IT WAS NOTED THAT THE MEASUREMENTS WERE TAKEN THROUGH A PROGRAMMER AS NO DEVICE HAD ANY RELATED RECORDS OR ALERTS REGARDING THIS ISSUE. THIS LEAD REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23861680 ↗
• InjuryDec 18, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED RIGHT ATRIAL (RA) LEAD WAS EXPLANTED DUE TO AN UNKNOWN PRODUCT PERFORMANCE ANOMALY. A NEW LEAD WAS IMPLANTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23840999 ↗
• MalfunctionDec 17, 2025Signal Artifact/Noise; High impedance; Over-Sensing; Signal Artifact/Noise; High impedance; Over-Sensing

  IT WAS REPORTED THAT THIS RIGHT ATRIAL (RA) LEAD RECORDED AN AUTOMATIC LEAD SAFETY SWITCH (LSS) DUE TO HIGH OUT-OF-RANGE PACING IMPEDANCE MEASUREMENTS GREATER THAN 3000 OHMS. TECHNICAL SERVICES (TS) REVIEWED THE DEVICE DATA AND NOTED A SUDDEN SPIKE FROM APPROXIMATELY THE 700-OHM RANGE TO GREATER THAN 3000 OHMS, AFTER WHICH THE IMPEDANCE RETURNED TO APPROXIMATELY THE 400-OHM RANGE. ADDITIONALLY, NOISE WAS OBSERVED WHEN THE DEVICE AUTOMATICALLY REVERTED TO UNIPOLAR CONFIGURATION, AND THIS NOISE WAS SENSED DURING ATRIAL FIBRILLATION (AF) EPISODES. TS SUSPECTED A CONNECTION ISSUE AND PROVIDED RECOMMENDATIONS TO REPROGRAM THE LEAD BACK TO BIPOLAR CONFIGURATION AND ADJUST SENSING SETTINGS. NO ADVERSE PATIENT EFFECTS WERE REPORTED. THIS RA LEAD REMAINS IN SERVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23832740 ↗
• InjuryDec 12, 2025Fracture; High impedance; Fracture; High impedance

  IT WAS REPORTED THAT THIS RIGHT ATRIAL (RA) LEAD EXHIBITED A FRACTURE. AS A RESULT, HIGH OUT OF RANGE PACING IMPEDANCE MEASUREMENTS WERE OBSERVED. TECHNICAL SERVICES (TS) RECOMMENDED REPROGRAMMING OPTIONS TO AVOID THE RA ALERTS. NO ADVERSE PATIENT EFFECTS WERE REPORTED. THIS RA LEAD REMAINS IN SERVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23791468 ↗
• InjuryDec 2, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THIS RIGHT ATRIAL (RA) LEAD WAS SURGICALLY ABANDONED DUE TO AN 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 23690798 ↗
• InjuryNov 24, 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. THERE WERE NO ADDITIONAL ADVERSE PATIENT EFFECTS REPORTED. THE RA LEAD WAS EXPLANTED.

  Patient problems: Unspecified Infection

  MAUDE report 23635710 ↗
• InjuryNov 6, 2025Defective Device; Defective Device

  IT WAS REPORTED THAT THIS RIGHT ATRIAL (RA) LEAD WAS EXPLANTED AND REPLACED DUE TO A NONSPECIFIC PRODUCT PERFORMANCE ISSUE. THIS PRODUCT HAS NOT BEEN RETURNED FOR ANALYSIS. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23493951 ↗
• InjuryNov 6, 2025Defective Device; Defective Device

  IT WAS REPORTED RIGHT ATRIAL (RA) LEAD WAS EXPLANTED DUE TO AN UNKNOWN PRODUCT PERFORMANCE ANOMALY. NO NEW LEAD WAS IMPLANTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23486850 ↗
• InjuryOct 28, 2025Failure to Capture; Fracture; High impedance; Defective Device; Insufficient Device Problem Information; Failure to Capture; Fracture; High impedance; Defective Device; Insufficient Device Problem Information

  IT WAS REPORTED THAT THIS RIGHT ATRIAL (RA) LEAD WAS EXPLANTED DUE TO UNKNOWN PRODUCT PERFORMANCE ANOMALY. A NEW LEAD WITH THE SAME MODEL WAS IMPLANTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Fatigue; No Clinical Signs, Symptoms or Conditions

  MAUDE report 23410041 ↗
• InjuryOct 24, 2025Defective Device; Defective Device

  IT WAS REPORTED THAT THIS RIGHT ATRIAL (RA) LEAD WAS EXPLANTED DUE TO UNKNOWN PRODUCT PERFORMANCE ANOMALY. THIS RA LEAD WAS REPLACED WITH A NON BOSTON SCIENTIFIC MODEL AND WILL NOT BE RETURNED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23380177 ↗
• InjuryOct 15, 2025Fracture; High impedance; Fracture; High impedance

  IT WAS REPORTED THAT THIS RIGHT ATRIAL (RA) LEAD EXHIBITED PACING IMPEDANCE MEASUREMENTS HIGHER THAN 3000 OHMS. WHEN REVIEWED UNDER FLUOROSCOPY, IT WAS CONFIRMED THAT IT HAD BEEN FRACTURED. AS A RESULT, THIS PACEMAKER SYSTEM WAS ELECTRICALLY ABANDONED AND REPLACED WITH A LEADLESS PACEMAKER. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23306191 ↗
• InjurySep 26, 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 AND VEGETATION ON LEAD. THERE WAS NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED. THIS RA LEAD WAS EXPLANTED.

  Patient problems: Unspecified Infection

  MAUDE report 23152073 ↗
• MalfunctionSep 9, 2025Signal Artifact/Noise; High impedance; High Capture Threshold; Signal Artifact/Noise; High impedance; High Capture Threshold

  IT WAS REPORTED THAT THIS PACEMAKER EXHIBITED HIGH PACING THRESHOLDS, NOISY SIGNALS AND HAD ITS LEAD SAFETY SWITCH ACTIVATED FOR ITS RIGHT ATRIAL (RA) LEAD DUE TO HIGH OUT OF RANGE IMPEDANCE MEASUREMENTS. TECHNICAL SERVICES (TS) WAS CONSULTED AND DISCUSSED STORED DATA, WITH TESTING PERFORMED FOR LEAD MEASUREMENTS. THE DEVICE WAS PROGRAMMED INTO UNIPOLAR PACING AND SENSING, WITH THE RESULTING MEASUREMENTS BEEN ACCEPTABLE. THIS DEVICE REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23005263 ↗
• InjurySep 5, 2025Defective Device; Defective Device

  IT WAS REPORTED THAT THIS RIGHT ATRIAL (RA) 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 22975383 ↗
• InjurySep 3, 2025Defective Device; Insufficient Device Problem Information; Defective Device; Insufficient Device Problem Information

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22959663 ↗

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-0084-2026 · Aug 20, 2025 · Open, Classified
  ACCOLADE DR EL MRI (Model L331)
• 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-0089-2026 · Aug 20, 2025 · Open, Classified
  Model Number L211 PROPONENT 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-0094-2026 · Aug 20, 2025 · Open, Classified
  Model Number L110, ESSENTIO SR SL MRI Pacemaker
• 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-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-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.