Epsila EV™ EAZ101Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 00763000369736), received between Jan 16, 2024 and Jul 2, 2026 — classified as 11 injuries.

The most frequently reported specific device problem is “Patient-Device Incompatibility” (1 report).

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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• InjuryJul 2, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ONE DAY POST-IMPLANT OF AN EXTRAVASCULAR (EV) LEAD, A CHEST X-RAY SHOWED THAT THE PATIENT SUFFERED A 2.5 CM APICAL PNEUMOTHORAX. IT WAS NOTED THAT THE EV LEAD WAS OUTSIDE THE PLEURAL SPACE. DRAINAGE WAS REQUIRED. THE EV LEAD REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Perforation; Pneumothorax

  MAUDE report 25692946 ↗
• InjuryDec 26, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS FURTHER REPORTED THAT THE EV LEAD WAS EXPLANTED AND REPLACED. IT WAS INDICATED THAT THE REPLACEMENT EV LEAD WAS ALSO POSSIBLY PLACED IN THE PLEURA AS LEAD MOVEMENT WAS NOTED WITH BREATHING; HOWEVER, THE REPLACEMENT EV LEAD MEASUREMENTS WERE ACCEPTABLE. ADDITIONALLY, IT WAS NOTED THAT THE PATIENT HAD A SMALL PLEURAL EFFUSION AROUND THE LEFT HEART ON CHEST X-RAY. AN X-RAY PERFORMED A WEEK AFTER EV LEAD REPLACEMENT SHOWED THE EFFUSION WAS SUBSIDING IN COMPARISON TO HOW IT WAS THE PREVIOUS WEEK. THE REPLACEMENT EV LEAD REMAINS IN USE.

  Patient problems: Perforation; Pleural Effusion

  MAUDE report 23897555 ↗
• InjuryJun 20, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT FOLLOWING IMPLANT, THE EXTRAVASCULAR (EV) LEAD EXPERIENCED OVERSENSING OF ARTIFACTS WHEN THE PATIENT WAS BEING TRANSFERRED FROM THE OPERATING TABLE TO THE HOSPITAL BED. IT WAS NOTED THAT RING 1 IMPEDANCES WERE FLUCTUATING SO THE DEVICE WAS LEFT WITH VENTRICULAR FIBRILLATION (VF) DETECTION ON AND THERAPIES OFF. POST-IMPLANT CHECK THREE HOURS LATER SHOWED FOUR NON-SUSTAINED VENTRICULAR TACHYCARDIA EPISODES OF NOISE WITH CONTINUED VARIABLE IMPEDANCES, THEREFORE ONLY NOISE TIMEOUT WAS SWITCHED OFF. IT WAS NOTED THAT THE LEAD WAS PLACED INSIDE A SECOND TUNNELING DURING IMPLANT, AS THE FIRST POSITIONING ON THE LEFT EDGE OF THE STERNUM SHOWED THE LEAD SLOWLY MOVING IN A LATERAL DIRECTION DURING BREATHING. THE NEXT DAY A CHEST X-RAY WAS PERFORMED IN WHICH THE LEAD WAS FOUND TO BE IN THE PLEURA. THE EV LEAD WAS EXPLANTED AND REPLACED CLOSER TO THE MIDLINE. INTERMITTENT P-WAVE OVERSENSING WAS OBSERVED WITH THE REPLACEMENT LEAD. THE PATIENT WAS CHECKED THE NEXT DAY AND NOTED A BIT OF PAIN AROUND THE INCISION SITE. THE NEW EV LEAD REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Neuropathy; Pain; Perforation

  MAUDE report 22299389 ↗
• InjuryMay 29, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT COMPLAINED OF FEELING BLUNT PAIN ALL AROUND AND UNDER THE STERNUM THREE HOURS POST IMPLANT OF AN EX TRAVASCULAR (EV) LEAD. IT WAS NOTED THAT THE PATIENT EXPERIENCED MUSCLE STIMULATION AND FELT THE SUBTHRESHOLD LEAD IMPEDANCE CHECKS. PLEURAL PLACEMENT OF THE LEAD WAS SUSPECTED DUE TO SLIGHT LATERAL MOVEMENT OF THE DISTAL PART OF THE LEAD WITH BREATHING ON FLUOROSCOPY. HIGH PACING THRESHOLD WAS ALSO OBSERVED. A COMPUTERIZED TOMOGRAPHY (CT) SCAN WAS PERFORMED TWO DAYS LATER WHICH SHOWED THE DISTAL PART OF THE LEAD WAS PLACED INSIDE THE PLEURAL SPACE. DURING THE REVISION, NOISE AND PAUSE PREVENTION EPISODES WERE NOTED. THE EXTRAVASCULAR (EV) LEAD WAS EXTRACTED AND REPLACED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Pain; Perforation

  MAUDE report 22106555 ↗
• InjuryDec 10, 2024Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS FURTHER REPORTED THAT THE PAIN WAS POSSIBLY DUE TO BRUISING OF THE MUSCLES BETWEEN THE STERNUM AND RIBS DURING TUNNELING.

  Patient problems: Bruise/Contusion; Implant Pain

  MAUDE report 20893670 ↗
• InjuryNov 21, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING A PROCEDURE INVOLVING THE TUNNELLING TOOL IT WAS NOTED THAT THE SHEATH HAD PUNCTURED THE PERICARDIUM, SHEATH REMOVED AND TUNNELED WITH SUCCESS. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Perforation

  MAUDE report 20748583 ↗
• InjuryJun 19, 2024Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT POST IMPLANT OF THE THE PATIENT'S EXTRAVASCULAR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (EV-ICD) SYSTEM AND WITH USE OF THE STERNAL TUNNELING TOOL THE PATIENT EXPERIENCED ONGOING SUBSTERNAL AND LATERAL MID-AXILLA POCKET SITE PAIN. THE PATIENT REQUIRED ONGOING MEDICATION FOR PAIN RELIEF, INCLUDING PARACETAMOL, TRAMADOL, AND IBUPROFEN. THE PAIN PROLONGED THE PATIENT'S HOSPITALIZATION. THE DEVICE REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT. THE PATIENT IS A PARTICIPANT IN A CLINICAL STUDY.

  Patient problems: Pain

  MAUDE report 19571095 ↗
• InjuryJun 7, 2024Patient-Device Incompatibility; Adverse Event Without Identified Device or Use Problem; Patient-Device Incompatibility; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING THE IMPLANT OF THE EXTRAVASCULAR (EV) LEAD, THE STERNAL TUNNELING TOOL AND SHEATHED LEAD WERE ABLE TO BE ADVANCED WITHOUT ISSUE, HOWEVER THE EV LEAD WAS OBSERVED TO MAKE WINDSHIELD WIPER MOVEMENTS AND LACERATED THE PERICARDIUM. THE LEAD AND SHEATH WERE WITHDRAWN, AND SOME PNEUMOPERICARDIUM DEVELOPED DUE TO SUSPECTED PERICARDIAL PERFORATION. THE INCISION WAS WIDENED AND THE PLANE OF THE STERNAL TUNNELING TOOL WAS SLIGHTLY RAISED, LEAVING IT ABOVE THE PERICARDIUM. THE EV LEAD WAS FIXED THRICE IN THE NEW POSITION, AND AIR OBSERVED AROUND THE LEAD WAS REMOVED FROM THE PERICARDIUM WITH A VACUUM DRAIN. THE FASCIA WAS THEN CLOSED, AND DEFIBRILLATION THRESHOLD (DFT) TESTING WAS THEN PERFORMED WHICH INITIALLY WAS NOT SUCCESSFUL AT CONVERTING THE INDUCED RHYTHM; HOWEVER, THERE WAS A SUBSEQUENT DELAYED CONVERSION TO SINUS RHYTHM. NO ADDITIONAL DFT TESTING WAS PERFORMED DUE TO THE SUSPICION OF A NEGATIVE INFLUENCE FROM THE PNEUMOPERICARDIUM, AND DUE TO POSSIBLE LOW SENSING IN THE BIPOLAR CONFIGURATION. ALL THERAPIES WERE TURNED OFF WHEN THE PROCEDURE WAS COMPLETED, AND THERAPIES WERE TURNED BACK ON WHEN THE PATIENT WAS DISCHARGED FIVE DAYS LATER. THE EV LEAD REMAINS

  Patient problems: Cardiac Perforation; Perforation

  MAUDE report 19485971 ↗
• InjuryFeb 28, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING AN ATTEMPTED IMPLANT, THE EXTRAVASCULAR (EV) LEAD WAS POSITIONED IN THE PLEURA AND SUBSEQUENTLY TAKEN OUT. THE EV LEAD WAS THEN PLACED A SECOND TIME WITH A LOT OF INTERFERENCE NOTED ON THE RING 1 CHANNEL. THE EV LEAD WAS REMOVED, AND A NEW EV LEAD WAS USED, HOWEVER INADEQUATE R-WAVE SENSING WAS NOTED. THE SECOND LEAD WAS REPOSITIONED, WITH SIMILAR LOW SENSING VALUES. THE IMPLANT WAS REPORTED TO BE UNSUCCESSFUL. IT WAS FURTHER REPORTED THAT THE PATIENT EXPERIENCED MILD PNEUMOTHORAX LEFT APICAL, HYDROTHORAX BASIC, HYDROPNEUMOTHORAX, AND HYPOTENSION. THE PATIENT¿S HOSPITALIZATION WAS EXTENDED FOR FOUR DAYS FOR OBSERVATION. THE NEXT DAY A DECREASE IN PNEUMOTHORAX AND PLEURAL FLUID WERE NOTED. IT WAS NOTED THAT DURING THE IMPLANT PROCEDURE, A CLASSICAL SUBCLAVICULAR DEVICE SYSTEM WAS IMPLANTED AFTER THE EV SYSTEM IMPLANT WAS UNSUCCESSFUL. THE PATIENT IS A PARTICIPANT IN A CLINICAL STUDY. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Low Blood Pressure/ Hypotension; Perforation; Pneumothorax

  MAUDE report 18798946 ↗
• InjuryJan 26, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED PROLONGED SUBSTERNAL PAIN AFTER IMPLANT OF THE EXTRAVASCULAR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) AND LEAD. A COMPUTERIZED TOMOGRAPHY (CT) SCAN REVEALED A LARGE PULMONARY EMBOLISM ON THE RIGHT SIDE. IT WAS THOUGHT IT MAY HAVE BEEN RELATED TO THE LONG PROCEDURE, ANESTHESIA, AND EXTRAVASCULAR IMPLANT TOOL. THE PATIENT WAS HOSPITALIZED AND TREATED WITH A SUBCUTANEOUS ANTICOAGULANT. IT WAS FURTHER REPORTED THAT AN ULTRASOUND SHOWED THAT THE PATIENT EXPERIENCED DEEP VENOUS THROMBOSIS IN BOTH LEGS. THE PATIENT EXPERIENCED WORSENING ABDOMINAL PAIN. A CT SCAN OF THE ABDOMEN REVEALED A HEMATOMA INSIDE THE RECTUS ABDOMINIS MUSCLE, BUT NO ACTIVE BLEEDING WAS FOUND. THE PATIENT¿S PAIN MEDICATION WAS INTENSIFIED, AND THEIR SUBCUTANEOUS ANTICOAGULANT DOSAGE WAS DECREASED. THE EXTRAVASCULAR SYSTEM REMAINS IN USE. THE PATIENT IS A PARTICIPANT IN A CLINICAL STUDY. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Hematoma; Pain; Pulmonary Embolism; Thrombosis/Thrombus

  MAUDE report 18587292 ↗
• InjuryJan 16, 2024Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT DURING THE IMPLANT PROCEDURE THE PATIENT  WAS NOTED TO BE BLEEDING FROM THE INCISION SITE POST USE OF THE STERNAL TUNNELING TOOL. IT WAS SUSPECTED THAT THE PHYSICIAN NICKED SOME OF THE SUBSTERNAL MUSCLE. A FIBRIN SEALANT SURGICAL PATCH WAS USED TO STOP THE BLEEDING. THE STERNAL TUNNELING TOOL WAS DISCARDED POST THE PROCEDURE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; No Clinical Signs, Symptoms or Conditions

  MAUDE report 18520713 ↗

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