INGEVITY™ MRI 7740Recalls & reported problems

Summary

The FDA's MAUDE database contains 3,257 adverse event reports that list this exact device (DI 00802526523427), received between Apr 22, 2016 and Sep 30, 2026 — classified as 11 deaths, 2,391 injuries, 855 malfunctions.

The most frequently reported specific device problem is “High impedance” (603 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 3,257 reports, in the reporter's own words as published by the FDA.

• InjurySep 30, 2026Signal Artifact/Noise; Over-Sensing; Material Integrity Problem; Insufficient Device Problem Information

  It was reported that this right atrial (RA) lead was surgically abandoned for an unknown product anomaly. A new lead was successfully implanted. No additional adverse patient effects were reported. This RA lead is no longer in service.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50947732 ↗
• InjurySep 28, 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 50910880 ↗
• MalfunctionSep 25, 2026High impedance

  It was reported that this right atrial (RA) lead was exhibiting high out of range lead pacing impedances. Technical Services (TS) reviewed and recommended programming for this lead as well as continued monitoring. This RA lead remains in service. No adverse patient effects were reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50899587 ↗
• InjurySep 25, 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 of a different model was placed. No additional adverse patient effects were reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50896964 ↗
• MalfunctionSep 23, 2026Signal Artifact/Noise; Over-Sensing

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50874124 ↗
• InjurySep 23, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that this right atrial (RA) lead was explanted due to other/non-product experience and a new RA lead of a different model was placed. No additional adverse patient effects were reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50868933 ↗
• MalfunctionSep 23, 2026Pacing Problem; Under-Sensing

  It was reported that this right atrial (RA) lead exhibited undersensing that led to overpacing. Technical Services (TS) was consulted and found that the atrial pacing percentage had increased over the previous month. TS believed the root cause was an incomplete atrioventricular search interval. No adverse patient effects were reported. This RA lead remains in service.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50867246 ↗
• InjurySep 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. No adverse patient effects were reported. The implantable lead was surgically abandoned.

  Patient problems: Unspecified Infection

  MAUDE report 50866123 ↗
• InjurySep 16, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Unspecified Infection

  MAUDE report 50793843 ↗
• InjurySep 16, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that this implantable lead was part of the system revision due to infection. Reportedly, there were vegetative growth on the leads. No adverse patient effects were reported. The implantable lead was explnted.

  Patient problems: Unspecified Infection

  MAUDE report 50784910 ↗
• MalfunctionSep 9, 2026High impedance

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50698801 ↗
• InjurySep 8, 2026Fracture; Insufficient Device Problem Information

  It was reported that this right atrial (RA) lead was explanted due to unknown product performance anomaly. This RA lead was replaced with a different model. No additional adverse patient effects were reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50668743 ↗
• MalfunctionSep 4, 2026Failure to Capture; High impedance; Low impedance

  It was reported that the implantable cardioverter defibrillator (ICD) and this right atrial (RA) lead exhibited a high out of range pacing impedance. The pacing impedance ranged from 500-600 Ohms, then started to dip into 200 Ohms, then went to greater than 3000 Ohms and has stayed at that measurement. Also, Technical Services (TS) reviewed presenting electrograms (EGM) and suspected there was a loss of capture on this RA lead and the right ventricular (RV) lead. TS recommended evaluating lead threshold with surface in clinic. TS confirmed the ICD had an appropriate safety margin based on the last in office measurement. This RA lead remains in service. No adverse patient effects were reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50602212 ↗
• InjurySep 4, 2026Signal Artifact/Noise; Fracture; High impedance

  It was reported that this right atrial (RA) lead was tested with pacing system analyzer (PSA) to confirm lead fracture which cause the impedance of more than 3000 ohms with noise on electrogram (EGM). The lead had broken under clavicle while extracting which cause a portion to remain implanted and partially explanted. A new lead was implanted. No additional adverse patient effects were reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50602142 ↗
• MalfunctionSep 4, 2026Fracture; High impedance

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50602126 ↗
• InjurySep 4, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that this right atrial (RA) lead was surgically abandoned due to an unknown reason. A new lead was implanted. No additional adverse patient effects were reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50602050 ↗
• MalfunctionSep 4, 2026High impedance

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50600637 ↗
• InjurySep 2, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Unspecified Infection

  MAUDE report 50571394 ↗
• InjurySep 2, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that this right atrial (RA) lead had exhibited infection due to infected breast implant. As of this time, this RA lead remains in service. There was no additional adverse patient effects reported.

  Patient problems: Unspecified Infection

  MAUDE report 50566534 ↗
• MalfunctionAug 21, 2026High impedance

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50378995 ↗
• InjuryAug 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 was no additional adverse patient effects reported. The RA lead was explanted.

  Patient problems: Unspecified Infection

  MAUDE report 50266391 ↗
• MalfunctionAug 13, 2026Failure to Capture; High impedance

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50240188 ↗
• MalfunctionAug 11, 2026Signal Artifact/Noise; Over-Sensing

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50209676 ↗
• InjuryAug 11, 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 50207585 ↗
• InjuryAug 10, 2026Fracture; High impedance

  It was reported that this right atrial (RA) lead exhibited an impedance measurement of more than 3000 ohms due to lead fracture or breakage. This RA lead was surgically abandoned, and a new RA lead with a different model was implanted. No additional adverse patient effects were reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50196763 ↗

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-0082-2026 · Aug 20, 2025 · Open, Classified
  ACCOLADE DR SL MRI (Model L311)
• Z-0095-2026 · Aug 20, 2025 · Open, Classified
  Model Number L111, ESSENTIO DR SL MRI Pacemaker
• Z-0089-2026 · Aug 20, 2025 · Open, Classified
  Model Number L211 PROPONENT DR SL MRI Pacemaker
• 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-0094-2026 · Aug 20, 2025 · Open, Classified
  Model Number L110, ESSENTIO SR SL MRI Pacemaker
• Z-0097-2026 · Aug 20, 2025 · Open, Classified
  Model Number L131, ESSENTIO DR EL 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-1999-2021 · Jun 3, 2021 · Open, Classified
  Proponent pacemaker, Models: a) L200 b) L201 c) L209 d) L210 e) L211 f) L221 g) L231

…and 13 more.