INGEVITY™ MRI 7742Recalls & reported problems

Summary

The FDA's MAUDE database contains 3,967 adverse event reports that list this exact device (DI 00802526523489), received between Jan 18, 2017 and Sep 30, 2026 — classified as 24 deaths, 3,206 injuries, 737 malfunctions.

The most frequently reported specific device problem is “High impedance” (921 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 3,967 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 30, 2026Fracture

  It was reported that this right ventricular (RV) lead exhibited a potential fracture and was programmed for unipolar pacing. In addition, the patient was scheduled to undergo hyperbaric oxygen therapy (HBOT). Technical Services (TS) advised that the device has been tested for HBOT exposure up to 5.0 Atmospheres Absolute (ATA) and that no restrictions apply regarding the lead anomaly or unipolar pacing. To date, this RV lead remains in service. No adverse patient effects were reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50943050 ↗
• InjurySep 28, 2026High Capture Threshold

  Patient problems: Fall

  MAUDE report 50923249 ↗
• InjurySep 28, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Unspecified Infection

  MAUDE report 50917825 ↗
• InjurySep 26, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Unspecified Infection

  MAUDE report 50907237 ↗
• MalfunctionSep 25, 2026Insufficient Device Problem Information

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50903009 ↗
• InjurySep 25, 2026Insufficient Device Problem Information

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50899890 ↗
• InjurySep 25, 2026High impedance

  It was reported that this pacemaker system triggered a lead safety switch (LSS) due to a high out of range impedance measurements for its right ventricular (RV) lead. A revision was performed for the pacemaker since it just had a year left of battery longevity, with the RV lead to be revised at a later date since the patients vessel was occluded and no access was possible. A new pacemaker was implanted. This RV lead remains in service. No additional adverse patient effects were reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50897492 ↗
• DeathSep 24, 2026Insufficient Device Problem Information

  It was reported that this patient was scheduled to undergo a laser lead extraction procedure involving this right ventricular (RV) lead. Technical Services (TS) was consulted regarding magnet application instructions and the process for paging a local company representative. TS provided the requested information; however, no additional details regarding the reason for the procedure were provided. At this time, it had not been confirmed whether the procedure had been performed. This RV lead remains in service. No adverse patient effects were reported

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50885557 ↗
• MalfunctionSep 18, 2026High impedance

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50831296 ↗
• InjurySep 14, 2026Device Dislodged or Dislocated; High Capture Threshold

  It was reported that this right ventricular (RV) lead exhibited high pacing thresholds. On the fluoroscopy review, it was noted that there was little slack left for that RV lead which likely caused higher thresholds over time. This lead was surgically abandoned and a new lead was successfully placed. No additional adverse patient effects were reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50750815 ↗
• InjurySep 11, 2026Insufficient Device Problem Information

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50744402 ↗
• InjurySep 8, 2026Fracture; High impedance; High Capture Threshold

  Patient problems: Foreign Body In Patient

  MAUDE report 50679554 ↗
• InjurySep 8, 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 Methicillin-resistant Staphylococcus aureus (MRSA) infection. There were no additional adverse patient effects reported. The RV lead was explanted.

  Patient problems: Bacterial Infection

  MAUDE report 50674130 ↗
• MalfunctionSep 7, 2026High impedance

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50658545 ↗
• InjurySep 4, 2026Failure to Capture; Fracture; High impedance; Over-Sensing

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50619935 ↗
• MalfunctionSep 4, 2026High impedance

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50610772 ↗
• InjurySep 4, 2026High impedance; High Capture Threshold

  It was reported that this pacemaker system exhibited an alert for high out of range pacing impedance above 2500 Ohms, along with high capture thresholds. This right ventricular (RV) lead was capped. No additional adverse patient effects were reported. This lead won't return for analysis.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50602384 ↗
• InjurySep 4, 2026Failure to Capture; High impedance; Insufficient Device Problem Information

  It was reported that this lead was surgically abandoned due to an unknown reason. A new lead was successfully implanted. No additional adverse patient effects were reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50602337 ↗
• InjurySep 4, 2026Failure to Capture; Fracture

  It was reported that this right ventricular (RV) lead was surgically abandoned due to fracture resulting in loss of capture (LOC) and a new RV lead of a different model was placed. No additional adverse patient effects were reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50602117 ↗
• InjurySep 4, 2026Signal Artifact/Noise; High impedance; Insufficient Device Problem Information

  It was reported that this right ventricular (RV) lead was surgically abandoned due to unknown product performance anomaly and a new RV lead with different model was implanted. No additional adverse patient effects were reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50602084 ↗
• InjurySep 4, 2026Failure to Capture

  It was reported right ventricular (RV) lead was surgically abandoned due to loss of capture which was confirmed via threshold testing. A new lead was implanted. No additional adverse patient effects were reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50602049 ↗
• MalfunctionSep 4, 2026Failure to Capture

  It was reported that the patient with this implantable cardioverter defibrillator (ICD) system visited the emergency room (ER) with heart rate in the 30s and 40s range. The health care professional (HCP) called Technical Services (TS) for a consult review of the presenting electrogram (EGM). Upon review, the electrogram (EGM) showed possible loss of capture (LOC) on the right ventricular (RV) lead. No adverse patient effects were reported. This RV lead remains in service.

  Patient problems: Bradycardia

  MAUDE report 50601339 ↗
• InjurySep 4, 2026Signal Artifact/Noise

  It was reported that this right ventricular (RV) lead was explanted due to lead exhibited noise. A new lead with a different model was placed. This lead is for return. No additional adverse patient effects were reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50601115 ↗
• InjurySep 4, 2026Insufficient Device Problem Information

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50600735 ↗
• InjurySep 2, 2026High impedance; High Capture Threshold

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50573910 ↗

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-0095-2026 · Aug 20, 2025 · Open, Classified
  Model Number L111, ESSENTIO DR SL MRI Pacemaker
• Z-0084-2026 · Aug 20, 2025 · Open, Classified
  ACCOLADE DR EL MRI (Model L331)
• 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-0089-2026 · Aug 20, 2025 · Open, Classified
  Model Number L211 PROPONENT DR SL MRI Pacemaker
• 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-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-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-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)
• 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.