INGEVITY™+ 7840Recalls & reported problems

Summary

The FDA's MAUDE database contains 2,640 adverse event reports that list this exact device (DI 00802526604430), received between Apr 17, 2020 and Sep 30, 2026 — classified as 14 deaths, 2,195 injuries, 431 malfunctions.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (617 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 2,640 reports, in the reporter's own words as published by the FDA.

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

  Patient problems: Unspecified Infection

  MAUDE report 50941340 ↗
• InjurySep 28, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Unspecified Infection

  MAUDE report 50919280 ↗
• InjurySep 28, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Unspecified Infection

  MAUDE report 50917015 ↗
• InjurySep 28, 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 pocket erosion with infection. The patient was treated for antibiotic therapy and for continuous observation. There were no additional adverse patient effects reported. The RA lead was explanted.

  Patient problems: Erosion; Unspecified Infection

  MAUDE report 50916363 ↗
• MalfunctionSep 25, 2026Failure to Sense; Device Dislodged or Dislocated

  It was reported that no sensing activity was observed on this right atrial (RA) lead. Technical Services (TS) was consulted and upon review of data determined that the lead was likely dislodged. TS recommended an x ray to confirm lead location. No adverse patient effects were reported. This RA lead remains in service.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50898545 ↗
• MalfunctionSep 24, 2026Signal Artifact/Noise; Fracture; High impedance; Over-Sensing

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50890032 ↗
• InjurySep 24, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that patient with this right atrial (RA) lead had undergone thoracotomy due to suspected lead perforation. After thoracotomy and examination, it was confirmed that although the helix of this RA lead had not come loose, there were signs of abrasion against the chest wall, which was the source of the bleeding. This lead remains in service after the myocardium was sutured at the tip of the lead. No additional adverse patient effects were reported.

  Patient problems: Perforation

  MAUDE report 50880625 ↗
• InjurySep 23, 2026Signal Artifact/Noise; Fracture; High impedance; Under-Sensing; High Capture Threshold

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50876123 ↗
• MalfunctionSep 23, 2026Failure to Capture; High impedance; High Capture Threshold

  It was reported that this right ventricular (RV) lead exhibited high out of range pacing impedance measurements and there was no capture at high outputs. It was noted the patient would be seen again in two months to check the battery of the device. No adverse patient effects were reported. This RV lead remains in service.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50870134 ↗
• InjurySep 23, 2026Failure to Read Input Signal; High Capture Threshold

  It was reported that this right atrial (RA) lead exhibited elevated thresholds and dropped in amplitude. The lead was surgically revised and to date, the lead remains in service. No additional adverse patient effects were reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50865008 ↗
• InjurySep 17, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that the patient with this right atrial (RA) lead had swelling and possible infection. The patient fell and had a lump forming over the implant. There were no additional adverse patient effects reported. The RA lead remains in service.

  Patient problems: Swelling/ Edema; Unspecified Infection

  MAUDE report 50809548 ↗
• InjurySep 17, 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 50809495 ↗
• InjurySep 17, 2026Insufficient Device Problem Information

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50808402 ↗
• InjurySep 17, 2026Failure to Capture; Device Dislodged or Dislocated

  It was reported that the patient experienced sternal stimulation with this right atrial (RA) lead which exhibited loss of capture due to lead dislodgement which was confirmed via fluoroscopy. This RA lead was explanted, replaced with the same model and will not be returned. No additional adverse patient effects were reported.

  Patient problems: Device Overstimulation of Tissue

  MAUDE report 50805546 ↗
• InjurySep 17, 2026Failure to Capture; Device Dislodged or Dislocated; High Capture Threshold

  It was reported that this right atrial (RA) lead exhibited loss of capture (LOC) with elevated capture thresholds. Upon review, the lead appeared to be dislodged slightly. A revision procedure was performed and the RA lead was repositioned. The lead was again not clearly capturing and the patient reportedly felt fatigued. The patient was recommended to follow up with their clinic for thorough lead testing. This RA lead remains in service. No additional adverse patient effects were reported.

  Patient problems: Bradycardia; Fatigue

  MAUDE report 50805338 ↗
• MalfunctionSep 17, 2026Signal Artifact/Noise; Fracture; High impedance; Over-Sensing; Off-Label Use

  It was reported that the health care professional (HCP) requested a non-conditional magnetic resonance imaging (MRI) scan on device with high out of range pacing impedance measurements on this right atrial (RA) lead. Technical Services (TS) was consulted for further review. Upon review, the stored electrogram (EGM) showed a lead safety switch (LSS) from bipolar to unipolar configuration due to high out of range pacing impedance measurements. Further review of stored Atrial Tachy Response (ATR) events showed RA lead also exhibited myopotential oversensing noise. It was suspected cause to be due to lead fracture. No adverse patient effects were reported. At this time, this RA lead remains in service.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50804608 ↗
• InjurySep 16, 2026Signal Artifact/Noise; Fracture; Over-Sensing; Device Dislodged or Dislocated

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50794362 ↗
• InjurySep 15, 2026Device Dislodged or Dislocated

  It was reported that right atrial (RA) lead exhibited lead dislodgement due to suspected twiddling. Fluoroscopy and visual observation confirmed the dislodgement. This RA lead was explanted, replaced with the same model and will be returned for analysis. No additional adverse patient effects were reported.

  Patient problems: Twiddlers Syndrome

  MAUDE report 50776545 ↗
• InjurySep 14, 2026Device Dislodged or Dislocated

  It was reported that this right atrial (RA) lead was explanted due to dislodgement and a new RA lead was placed. No additional adverse patient effects were reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50749966 ↗
• InjurySep 11, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Unspecified Infection

  MAUDE report 50737293 ↗
• InjurySep 10, 2026Device Dislodged or Dislocated; Impedance Problem; High Capture Threshold

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50724981 ↗
• InjurySep 10, 2026Insufficient Device Problem Information

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50724917 ↗
• InjurySep 10, 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 50711150 ↗
• InjurySep 9, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Unspecified Infection

  MAUDE report 50701737 ↗

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-0094-2026 · Aug 20, 2025 · Open, Classified
  Model Number L110, ESSENTIO SR SL 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-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-0091-2026 · Aug 20, 2025 · Open, Classified
  Model Number L231, PROPONENT DR EL MRI Pacemaker
• Z-0095-2026 · Aug 20, 2025 · Open, Classified
  Model Number L111, ESSENTIO 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-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-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.