INGEVITY+Recalls & reported problems across all models

We found 3 models of INGEVITY+ by Boston Scientific Corporation in the FDA's device registry (GUDID). Together they are named in 16,054 adverse event reports in the FDA's MAUDE database, received between Apr 9, 2020 and Sep 30, 2026 — classified as 50 deaths, 12,731 injuries, 3,273 malfunctions.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (3,414 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Most reported INGEVITY+ problems

INGEVITY+ models

3 models, most reported first. Each model has its own page with its reports, recalls and device details.

• INGEVITY™+ 7841

  Drug eluting permanent right ventricular (RV) or right atrial (RA) pacemaker electrodes
  15 deaths7,419 reports
• INGEVITY™+ 7842

  Drug eluting permanent right ventricular (RV) or right atrial (RA) pacemaker electrodes
  21 deaths5,995 reports
• INGEVITY™+ 7840

  Drug eluting permanent right ventricular (RV) or right atrial (RA) pacemaker electrodes
  14 deaths2,640 reports

Recent INGEVITY+ adverse event reports

The 15 most recent reports across all models, 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 ↗
• 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 ↗
• 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, 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 ↗
• 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, 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, 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, 2026Failure to Capture; High impedance

  It was reported that this right atrial (RA) lead exhibited a loss of capture on the presenting electrogram. Additionally, a lead safety switch occurred that resulted in high out of range pace impedance measurements. Technical Services (TS) was consulted to review the system and found that the anomalies occurred while in bipolar mode. TS recommended adjusting to a unipolar pace and bipolar sense which resolved the loss of capture with full sensing available. TS noted that the health care professional was going to discuss further with the cardiologist and assess the chest x ray that was completed. No adverse patient effects were reported. This RA lead remains in service.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50946318 ↗
• 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, 2026Material Integrity Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50945082 ↗

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