INGEVITY™ MRI 7741Recalls & reported problems

Summary

The FDA's MAUDE database contains 7,874 adverse event reports that list this exact device (DI 00802526523458), received between Nov 1, 2016 and Sep 30, 2026 — classified as 36 deaths, 6,159 injuries, 1,679 malfunctions.

The most frequently reported specific device problem is “High impedance” (1,589 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 7,874 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 30, 2026High impedance

  It was reported that this pacemaker system exhibited high out of range pace impedance measurements above 3000 ohms. No adverse patient effects were reported. This system remains in service.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50950839 ↗
• InjurySep 30, 2026Fracture; High impedance

  It was reported that this right atrial (RA) lead exhibited an impedance increase to greater than 3000 ohms, and a lead fracture was suspected. The anomaly was identified during a routine clinic evaluation due to inconsistent remote monitoring. No fall or other known traumatic event was reported. This RA lead was explanted, replaced and will be returned. No additional adverse patient effects were reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50942241 ↗
• InjurySep 30, 2026High Capture Threshold

  It was reported that this right ventricular (RV) lead exhibited elevated pacing thresholds. A laser lead extraction was performed, and this RV lead was subsequently replaced. No additional adverse patient effects were reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50942136 ↗
• InjurySep 29, 2026Insufficient 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 50936909 ↗
• MalfunctionSep 29, 2026Insufficient Device Problem Information

  It was reported that an alert was displayed for this right atrial (RA) lead. No specific details for the alert are available at this time. This RA lead remains in service. No adverse patient effects were reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50933793 ↗
• InjurySep 29, 2026Insufficient Device Problem Information

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50927647 ↗
• InjurySep 28, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Unspecified Infection

  MAUDE report 50917799 ↗
• InjurySep 28, 2026High impedance

  Patient problems: Foreign Body In Patient

  MAUDE report 50915458 ↗
• MalfunctionSep 28, 2026Signal Artifact/Noise; Fracture; High impedance; Over-Sensing; Material Integrity Problem

  Patient problems: Device Overstimulation of Tissue

  MAUDE report 50914598 ↗
• InjurySep 26, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Unspecified Infection

  MAUDE report 50907232 ↗
• InjurySep 25, 2026Insufficient Device Problem Information

  It was reported that this right atrial (RA) lead was explanted due to unknown cause. 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 50899889 ↗
• InjurySep 25, 2026Insufficient Device Problem Information

  It was reported that this right ventricular (RV) lead exhibited a nonspecific product performance anomaly. Subsequently, this lead was capped and replaced. No additional adverse patient effects were reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50893451 ↗
• MalfunctionSep 23, 2026High impedance

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50876081 ↗
• InjurySep 23, 2026Insufficient Device Problem Information

  It was reported that this right ventricular (RV) lead was explanted due to product performance anomaly 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 50868943 ↗
• InjurySep 23, 2026Over-Sensing; Failure to Read Input Signal; High Capture Threshold

  It was reported that this right atrial (RA) lead was surgically abandoned due to unknown product performance anomaly and a new RA lead with different model was implanted. No additional adverse patient effects were reported.Additional information indicated that this RA lead exhibited a high capture threshold and low p waves. Additionally, the lead was oversensing, prompting the physician to implant a new lead. No adverse patient effects were reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50868051 ↗
• 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 50866135 ↗
• InjurySep 17, 2026Fracture; Insufficient Device Problem Information

  It was reported that this right atrial (RA) lead was explanted due to product performance anomaly a new RA lead of different model was placed. No additional adverse patient effects were reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50802601 ↗
• MalfunctionSep 17, 2026Under-Sensing

  It was reported that this pacemaker exhibited undersensing for its right atrial (RA) lead. Technical Services (TS) was consulted and discussed stored data, with reprogramming of the RA sensitivity recommended. This device remains in service. No adverse patient effects were reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50802475 ↗
• MalfunctionSep 17, 2026Failure to Capture

  It was reported that the health care professional (HCP) called Technical Services (TS) for review of an episode on the presenting electrogram (EGM) for this pacemaker system. TS reviewed the data and noted there may be atrial loss of capture (LOC). TS also noted the device was programmed oddly and did not believe the episode was slow ventricular tachycardia (VT), rather, loss of AV synchrony due to programming. TS discussed how the device was programmed with the HCP. Information from the field was received and it was believed to be functional LOC due to refractory tissue. No adverse patient effects were reported. This right atrial (RA) lead remains in service.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50802099 ↗
• InjurySep 16, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Unspecified Infection

  MAUDE report 50793786 ↗
• 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 lead. No adverse patient effects were reported. The implantable lead was explanted.

  Patient problems: Unspecified Infection

  MAUDE report 50784763 ↗
• InjurySep 10, 2026Failure to Capture; Insufficient Device Problem Information

  It was reported that this right atrial (RA) lead exhibited unknown product performance anomaly. A revision procedure was performed. This RA lead was surgically abandoned and replaced with a new lead successfully. No additional adverse patient effects were reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50717461 ↗
• InjurySep 9, 2026Off-Label Use; Material Integrity Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50699530 ↗
• InjurySep 8, 2026Difficult to Remove

  Patient problems: Bacterial Infection

  MAUDE report 50678901 ↗
• InjurySep 7, 2026Signal Artifact/Noise; Failure to Capture; Fracture; Over-Sensing; Pacing Problem

  Patient problems: Syncope/Fainting

  MAUDE report 50658538 ↗

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

…and 13 more.