INGEVITY™+ 7842Recalls & reported problems

Summary

The FDA's MAUDE database contains 5,995 adverse event reports that list this exact device (DI 00802526604522), received between Apr 9, 2020 and Sep 30, 2026 — classified as 21 deaths, 4,272 injuries, 1,702 malfunctions.

The most frequently reported specific device problem is “High Capture Threshold” (1,204 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 5,995 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 30, 2026Material Integrity Problem

  It was reported that this brady lead was not successfully implanted due to helix got bent after multiple placement attempts. This brady lead was replaced with a non Boston Scientific model. No adverse patient effects were reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50949522 ↗
• MalfunctionSep 30, 2026Fracture; High impedance

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50947592 ↗
• InjurySep 30, 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 50947540 ↗
• InjurySep 30, 2026Signal Artifact/Noise

  It was reported that this right ventricular (RV) lead was surgically abandoned due to concern with the RV channel. Technical Services (TS) reviewed the presenting electrogram (EGM) and found deflections on the RV channel. The noise was not being sensed by the device. A new RV lead was successfully implanted. No additional adverse patient effects were reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50946741 ↗
• InjurySep 30, 2026Material Integrity Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50945082 ↗
• InjurySep 30, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that this right ventricular (RV) lead had perforated through the wall of patient's heart. This lead was explanted and a new RV lead was placed. No additional adverse patient effects were reported.

  Patient problems: Perforation

  MAUDE report 50944843 ↗
• InjurySep 30, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that this right ventricular (RV) lead was explanted 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 50943824 ↗
• 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 50942569 ↗
• InjurySep 29, 2026Failure to Capture; Device Dislodged or Dislocated

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50939402 ↗
• MalfunctionSep 29, 2026High Capture Threshold

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50938702 ↗
• InjurySep 29, 2026Insufficient Device Problem Information

  It was reported right ventricular (RV) lead was surgically abandoned 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 50937002 ↗
• InjurySep 29, 2026Signal Artifact/Noise; Failure to Capture; Fracture; Impedance Problem

  It was reported that this lead exhibited fracture, noisy signals, loss of capture (LOC) and pacing impedance issues. Subsequently, this lead was explanted and successfully replaced. No additional adverse patient effects were reported. This product is expected to be returned for analysis.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50934463 ↗
• MalfunctionSep 29, 2026Material Integrity Problem; Positioning Problem

  It was reported that this Brady lead was not successfully implanted due to the septum that was chosen during implant was too thick and the numbers were getting worse after the catheter was slit. Furthermore, the lead was pulled out, and it was noted that the lead was stretched. A new lead was implanted. No adverse patient effects were reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50933204 ↗
• MalfunctionSep 29, 2026Signal Artifact/Noise; High impedance; Pacing Problem

  It was reported that this right ventricular (RV) lead exhibited noisy signals due to unexpected programming. Additionally, a red alert was found for high out of range pace impedance measurements. Technical Services (TS) was consulted and found the system to be operating in unipolar rather than bipolar with no previous history of a lead safety switch. TS believed a bigger lead anomaly was present but have no confirmation at this time. TS noted that pacing inhibition greater than 2 seconds had occurred at times. No additional adverse patient effects were reported. This RV lead remains in service.

  Patient problems: Asystole

  MAUDE report 50932547 ↗
• 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 50930528 ↗
• MalfunctionSep 29, 2026Insufficient Device Problem Information

  It was reported that this right ventricular (RV) lead was attempted due to unknown product performance reason. This RV lead was replaced and not implanted. No adverse patient effects were reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50927891 ↗
• MalfunctionSep 29, 2026Nonstandard Device; Device Contamination with Body Fluid

  It was reported that this Brady lead was not implanted successfully due to tissue stuck in helix and a new Brady lead of the same model was placed. This lead will be returned by the hospital. No adverse patient effects were reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50927811 ↗
• InjurySep 28, 2026Failure to Capture

  Patient problems: Bradycardia

  MAUDE report 50923790 ↗
• InjurySep 28, 2026Mechanical Problem; Material Integrity Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50923406 ↗
• InjurySep 28, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that this left bundle branch (LBB) lead was part of a system revision due to infection. There were no additional adverse patient effects reported. The LBB lead was explanted.

  Patient problems: Unspecified Infection

  MAUDE report 50917391 ↗
• MalfunctionSep 28, 2026Failure to Capture

  t was reported that the cardiac resynchronization therapy pacemaker (CRT-P) and this left ventricular (LV) lead suspended a left ventricular automatic threshold (LVAT) test. Technical Services (TS) reviewed device data and confirmed the LVAT was suspended due to fusion beats. Also, the presenting electrogram (EGM) exhibited loss of capture on the LV lead due to the LV and right ventricular (RV) beats falling on top of each other. TS recommended further evaluation in clinic. This LV lead remains in service. No adverse patient effects were reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50915460 ↗
• MalfunctionSep 28, 2026Insufficient Device Problem Information

  It was reported that this Brady lead was not implanted successfully due to product performance anomaly and a new Brady lead of the same model was placed. No adverse patient effects were reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50911013 ↗
• MalfunctionSep 25, 2026Failure to Read Input Signal; Under-Sensing

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50906244 ↗
• MalfunctionSep 25, 2026Insufficient Device Problem Information

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50904683 ↗
• MalfunctionSep 25, 2026Failure to Capture; High impedance; Failure to Read Input Signal

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50904251 ↗

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-0094-2026 · Aug 20, 2025 · Open, Classified
  Model Number L110, ESSENTIO SR SL MRI Pacemaker
• Z-0082-2026 · Aug 20, 2025 · Open, Classified
  ACCOLADE DR SL MRI (Model L311)
• 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-0097-2026 · Aug 20, 2025 · Open, Classified
  Model Number L131, ESSENTIO DR EL MRI 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-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-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-1998-2021 · Jun 3, 2021 · Open, Classified
  Essentio pacemaker, Models: a) L100 b) L101 c) L110 d) L111 e) L121 f) L131

…and 13 more.