Epsila EV™ MRI SureScan™ EV240163Recalls & reported problems

Summary

The FDA's MAUDE database contains 634 adverse event reports that list this exact device (DI 00763000369781), received between Jan 2, 2024 and Sep 30, 2026 — classified as 13 deaths, 322 injuries, 299 malfunctions.

The most frequently reported specific device problem is “Over-Sensing” (387 reports).

1 other recall cover devices cleared under the same FDA submission (P220012); 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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 634 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 30, 2026Over-Sensing; Under-Sensing

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50951818 ↗
• MalfunctionSep 30, 2026Signal Artifact/Noise; Over-Sensing; Under-Sensing; Decreased Sensitivity

  It was reported that there was a lead warning due to oversensing of noise on the Extravascular (EV) lead along with pause prevention episodes. Oversensing and undersensing appear to be due to diminished and variable r-wave amplitudes. It was noted that the low r-wave amplitude was likely causing the oversensing issues. The EV lead remains in use. No patient complications have been reported as a result of this event.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50949609 ↗
• InjurySep 30, 2026Signal Artifact/Noise; Over-Sensing; Inappropriate/Inadequate Shock/Stimulation

  Patient problems: Shock from Patient Lead(s)

  MAUDE report 50948731 ↗
• MalfunctionSep 29, 2026Signal Artifact/Noise; Over-Sensing

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50935298 ↗
• InjurySep 28, 2026Signal Artifact/Noise; Over-Sensing; Device Sensing Problem

  It was reported that due to a sensing issue, the Extravascular (EV) lead vector was changed to ring1 to can. The Extravascular (EV) lead remains in use. No patient complications have been reported as a result of this event.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50915508 ↗
• InjurySep 24, 2026Signal Artifact/Noise; Over-Sensing; Inappropriate/Inadequate Shock/Stimulation

  It was reported that the patient received an inappropriate shock due to oversensing noise on the Extravascular (EV) lead. The patient works out regularly and there is a question if the noise and oversensing isn't from that. Reprogramming had been done to the oversensing prevention. The EV lead remains in use. No further patient complications have been reported as a result of this event.

  Patient problems: Shock from Patient Lead(s)

  MAUDE report 50886470 ↗
• InjurySep 23, 2026Adverse Event Without Identified Device or Use Problem

  It was further reported that per the physician there was no infection, but pocket erosion occurred.

  Patient problems: Discomfort; Pocket Erosion; Swelling/ Edema; Unspecified Infection

  MAUDE report 50876085 ↗
• MalfunctionSep 23, 2026Unstable Impedance

  Patient problems: Insufficient Information

  MAUDE report 50875853 ↗
• InjurySep 23, 2026Over-Sensing

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50875660 ↗
• InjurySep 23, 2026High impedance; Impedance Problem; Unstable Impedance

  It was reported that there was high voltage lead impedance warning for high impedance and variations in impedance measurements. The patient was admitted to the Emergency Room after an additional alert occurred for the high voltage impedance. An x-ray was done while the patient was in the hospital and it showed the lead in a stable position with no lead integrity issues seen. A clinical data review showed implant impedance values were followed by a decrease in all impedance a few days after implant. This was followed by a gradual rise in impedance, then stabilization followed by recent increases in all impedances. The patient was brought back in to disable the audible alert and is being monitored. The Extravascular (EV) lead remains in use. No patient complications have been reported as a result of this event.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50872912 ↗
• InjurySep 23, 2026Failure to Convert Rhythm

  It was reported that the day of the procedure, defibrillation threshold testing (DFT) failed at 35 joules. The next day, there was failed DFT at 35 joules and 40 joules. Two days after implant the Extravascular Implantable Cardioverter Defibrillator (EV-ICD) and the Extravascular (EV) lead were explanted and replaced two days later. No patient complications have been reported as a result of this event.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50869265 ↗
• MalfunctionSep 18, 2026Over-Sensing

  It was reported that long duration p-wave oversensing was observed on the Extravascular (EV) lead. The EV lead remains in use. No patient complications have been reported as a result of this event.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50821278 ↗
• InjurySep 17, 2026Over-Sensing

  It was reported that p-wave oversensing was observed on the Extravascular (EV) lead resulting in ventricular oversensing episode whe re inappropriate detection and therapy was withheld. The p-waves appear when the patient exercises. Reprogramming was done and the EV lead remains in use. No patient complications have been reported as a result of this event.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50800755 ↗
• MalfunctionSep 15, 2026Over-Sensing

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50780119 ↗
• MalfunctionSep 14, 2026Low impedance

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50762745 ↗
• MalfunctionSep 11, 2026Signal Artifact/Noise; Over-Sensing

  It was reported that there was a noise warning for oversensing noise on the Extravascular (EV) lead. The EV lead remains in use. No patient complications have been reported as a result of this event.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50736285 ↗
• MalfunctionSep 10, 2026Signal Artifact/Noise; Over-Sensing

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50722352 ↗
• MalfunctionSep 10, 2026High impedance

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50721259 ↗
• InjurySep 10, 2026Inappropriate/Inadequate Shock/Stimulation

  It was reported by a family member that the patient had some issues with the device. The patient experienced an inappropriate shock and had adjustments made. The Extravascular (EV) lead remains in use. No further patient complications have been reported as a result of this event.

  Patient problems: Shock from Patient Lead(s)

  MAUDE report 50718378 ↗
• MalfunctionSep 10, 2026Signal Artifact/Noise; Over-Sensing

  It was reported that oversensing noise was observed on the Extravascular (EV) lead. The EV lead remains in use. No patient complications have been reported as a result of this event.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50717577 ↗
• InjurySep 9, 2026Signal Artifact/Noise; Over-Sensing; Inappropriate/Inadequate Shock/Stimulation

  Patient problems: Ventricular Fibrillation

  MAUDE report 50698720 ↗
• MalfunctionSep 9, 2026Signal Artifact/Noise; Over-Sensing

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50698225 ↗
• MalfunctionSep 9, 2026Low impedance; Impedance Problem

  It was reported that the day after implant, there was an alert for low impedance on ring1 to coil2 of the Extravascular (EV) lead. There also was an abrupt drop in impedance on ring1 to ring2 on the lead trends. Two days after implant the impedance values were within normal limits. The EV lead remains in use. No patient complications have been reported as a result of this event.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50693256 ↗
• MalfunctionSep 8, 2026Low impedance

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50676361 ↗
• MalfunctionSep 8, 2026Signal Artifact/Noise; Over-Sensing

  It was reported that there was a noise warning for oversensing noise on the Extravascular (EV) lead. The EV lead remains in use. The patient had an office visit planned for further evaluation, but missed the appointment. The patient is a participant in a clinical study. No patient complications have been reported as a result of this event.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50674188 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under P220012. One submission often covers many models, so check the product and lot details in each record.

• Z-0726-2026 · Oct 29, 2025 · Open, Classified
  Aurora EV-ICD and Clinical EV-ICD, single chamber, extravascular implantable cardioverter defibrillators (ICD), Product Number DVEA3E4