INGEVITY™+ 7841Recalls & reported problems

Summary

The FDA's MAUDE database contains 7,419 adverse event reports that list this exact device (DI 00802526604577), received between Apr 9, 2020 and Sep 30, 2026 — classified as 15 deaths, 6,264 injuries, 1,140 malfunctions.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (1,658 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 7,419 reports, in the reporter's own words as published by the FDA.

• InjurySep 30, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Unspecified Infection

  MAUDE report 50953423 ↗
• InjurySep 30, 2026Device Dislodged or Dislocated

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50951579 ↗
• MalfunctionSep 30, 2026Failure to Capture

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50949532 ↗
• InjurySep 30, 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 50947599 ↗
• MalfunctionSep 30, 2026Signal Artifact/Noise; Failure to Capture; Fracture; High impedance; Over-Sensing

  It was reported that this right atrial (RA) lead with the cardiac resynchronization therapy defibrillator (CRT-D) exhibited high out of range pacing impedances. There was loss of capture (LOC) noted and noisy signals. Technical Services (TS) reviewed and found this to be indicative of a lead fracture. Programming options were provided. This RA lead remains in service. No adverse patient effects were reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50947152 ↗
• InjurySep 30, 2026High impedance

  It was reported that the implanted lead was surgically abandoned due to unknown product performance anomaly. Fluoroscopy was performed and antibiotic was administered. A new brady lead was subsequently implanted. No adverse patient effects were reported.Additional information was received that this implantable lead was capped and replaced due to recorded high pacing impedance measurements. No adverse patient effects were reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50947150 ↗
• InjurySep 30, 2026Fracture

  It was reported that this right atrial (RA) lead was explanted due to subclavian crush. This RA lead was replaced with the same model and will not be returned for analysis. No additional adverse patient effects were reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50946353 ↗
• MalfunctionSep 30, 2026Material Integrity Problem

  It was reported that this right atrial (RA) lead was a case of an attempted implant due to terminal pin anomaly on the RA lead. As the RA lead was implanted without anomalies and test via pacing system analyzer (PSA), however, when RA lead was placed in the right ventricular (RV) lead port of the header a small blips or non physiologic pulses on the RA channel was noted. The RA lead terminal was removed and placed back on the PSA with normal tracing, however, when placed back in the RA port of the device baseline blips still present and not oversensed. Furthermore, the impedance and sensing were normal. It was then confirmed that the anomaly was related to the terminal pin when RV lead was placed in the RA port and there were no blips of noise were seen. This RA lead was replaced with the same model, not implanted and will be returned for analysis. No adverse patient effects were reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50946220 ↗
• MalfunctionSep 30, 2026Material Integrity Problem

  It was reported that this right atrial (RA) lead was not successfully implanted due to the tip of the lead got kinked upon lead insertion. This RA lead was replaced with the same model. No adverse patient effects were reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50945636 ↗
• InjurySep 30, 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 50942568 ↗
• InjurySep 30, 2026Device Dislodged or Dislocated

  It was reported that this right atrial (RA) lead was confirmed to be dislodged by X ray one day post implant. This RA lead was repositioned and remains in service. No additional adverse patient effects were reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50942272 ↗
• MalfunctionSep 30, 2026Difficult to Insert; Material Integrity Problem

  It was reported that this right atrial (RA) lead could not be used because the stylet could only be advanced halfway and was unable to reach the distal tip. No lead imaging was performed. This RA lead was replaced with a new lead that was successfully implanted. The cause of the anomaly remained undetermined during the procedure. No adverse patient effects were reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50942188 ↗
• InjurySep 29, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Unspecified Infection

  MAUDE report 50940065 ↗
• MalfunctionSep 29, 2026Insufficient Device Problem Information

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50938701 ↗
• MalfunctionSep 29, 2026Insufficient Device Problem Information

  It was reported that this right ventricular (RV) lead was not successfully implanted due to unknown product performance anomaly. A RV lead of the different model was successfully implanted. No adverse patient effects were reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50937300 ↗
• InjurySep 29, 2026Insufficient Device Problem Information

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50937001 ↗
• InjurySep 29, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that the patient with this right atrial (RA) lead experienced a pericardial effusion. Earlier this year, approximately 1000 cubic centimeters (cc) of fluid were drained from the pericardial space. Three days later, an additional 350 cc of fluid was removed. The patient was subsequently monitored with periodic echocardiograms. No recurrence of fluid accumulation has been observed to date. At this time, this RA lead remains in service. No additional adverse patient effects were reported.

  Patient problems: Pericardial Effusion

  MAUDE report 50935443 ↗
• MalfunctionSep 29, 2026Failure to Capture; High impedance

  It was reported that this implantable cardioverter defibrillator (ICD) exhibited high out of range impedance measurements and a signal artifact monitoring (SAM) episode due to artifact related to the minute ventilation (MV) feature signal on its right atrial (RA) lead. Additionally, there was loss of capture (LOC) for its RA lead following the SAM episode. Technical Services (TS) was consulted and discussed stored data. The device will have its programming adjusted and the patient will continue to be monitored. This device remains in service. No adverse patient effects were reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50933534 ↗
• MalfunctionSep 29, 2026Failure to Capture

  It was reported that this right atrial (RA) lead exhibited loss of capture (LOC) on a presenting electrogram (EGM) and then in clinic when evaluating. The health care professional (HCP) will obtain x ray imaging and decide on next steps. Additional information is being requested from the field. This RA lead remains in service. No additional adverse patient effects were reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50932065 ↗
• InjurySep 29, 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 50930223 ↗
• InjurySep 29, 2026Insufficient 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. No additional adverse patient effects were reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50927892 ↗
• InjurySep 28, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Unspecified Infection

  MAUDE report 50923940 ↗
• InjurySep 28, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Unspecified Infection

  MAUDE report 50919972 ↗
• InjurySep 28, 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 infection. There were no additional adverse patient effects reported. The RV lead was explanted.

  Patient problems: Unspecified Infection

  MAUDE report 50919283 ↗
• InjurySep 28, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Unspecified Infection

  MAUDE report 50917020 ↗

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-0089-2026 · Aug 20, 2025 · Open, Classified
  Model Number L211 PROPONENT DR SL MRI Pacemaker
• 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-0094-2026 · Aug 20, 2025 · Open, Classified
  Model Number L110, ESSENTIO SR SL MRI Pacemaker
• Z-0091-2026 · Aug 20, 2025 · Open, Classified
  Model Number L231, PROPONENT DR EL MRI Pacemaker
• Z-0081-2026 · Aug 20, 2025 · Open, Classified
  ACCOLADE SR SL MRI (Model L310)
• Z-0084-2026 · Aug 20, 2025 · Open, Classified
  ACCOLADE DR EL MRI (Model L331)
• 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-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-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.