Epsila EV MRI SureScanRecalls & reported problems across all models

We found 2 models of Epsila EV MRI SureScan by Medtronic, Inc. in the FDA's device registry (GUDID). Together they are named in 725 adverse event reports in the FDA's MAUDE database, received between Jan 2, 2024 and Sep 30, 2026 — classified as 15 deaths, 365 injuries, 345 malfunctions.

The most frequently reported specific device problem is “Over-Sensing” (447 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 Epsila EV MRI SureScan problems

Epsila EV MRI SureScan models

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

• Epsila EV™ MRI SureScan™ EV240163

  Permanent defibrillator electrodes
  13 deaths634 reports
• Epsila EV™ MRI SureScan™ EV240152

  Implantable cardioverter defibrillator (non-CRT)
  2 deaths91 reports

Recent Epsila EV MRI SureScan adverse event reports

The 15 most recent reports across all models, 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 30, 2026Signal Artifact/Noise; Over-Sensing

  It was reported that noise episodes that were likely due to myopotentials were 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 50945915 ↗
• MalfunctionSep 29, 2026Signal Artifact/Noise; Over-Sensing

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50936259 ↗
• 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 ↗
• MalfunctionSep 24, 2026Signal Artifact/Noise; Over-Sensing; Under-Sensing

  It was reported that there was a noise warning for oversensing noise episodes on the Extravascular (EV) lead. Also present were episodes of T-Wave Oversensing (TWOS) and undersensing was also noted. 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 50883595 ↗
• 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 ↗

Other Medtronic, Inc. products

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