EP XT™ M0042007970Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 08714729877578), received between Feb 26, 2020 and Mar 25, 2020 — classified as 3 injuries.

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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryMar 25, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  LOCALIZE PM007 CLINICAL STUDY. IT WAS REPORTED THAT THE PATIENT EXPERIENCED PNEUMONIA, "CARDIAL DECOMPOSITION," PAIN IN THE LOWER STOMACH, ASCITES AND PLEURAL EFFUSION FOLLOWING AN ABLATION PROCEDURE WITH AN INTELLANAV MIFI OPEN-IRRIGATED ABLATION CATHETER, AN INTELLAMAP ORION HIGH RESOLUTION MAPPING CATHETER, A TSX FIXED CURVE SHEATH, AN EP-XT DIAGNOSTIC CATHETER AND A NON-BOSTON SCIENTIFIC STEERABLE INTRODUCER. THE PATIENT WAS GIVEN INTRAVENOUS OR INTRAMUSCULAR ANTIBIOTICS AND THE EVENT RESOLVED. THE SUSPECTED CAUSE WAS EXERTIONAL DYSPNEA AFTER ABLATION. IT WAS FURTHER REPORTED THAT THE DEVICE WOULD NOT BE RETURNED BECAUSE THERE WAS NO TECHNICAL FAILURE OBSERVED DURING THE PROCEDURE. AT THE TIME THE EVENT STARTED, THE PATIENT WAS ALREADY RELEASED FROM THE HOSPITAL.

  Patient problems: Abdominal Pain; Complaint, Ill-Defined; Dyspnea; Heart Failure; Pleural Effusion; Pneumonia

  MAUDE report 9878896 ↗
• InjuryFeb 26, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL STUDY (B)(6). IT WAS REPORTED THE PATIENT EXPERIENCED A FEVER AND INFECTION. ON (B)(6) 2019, AFTER AN ABLATION PROCEDURE WITH AN INTELLANAV MIFI OPEN-IRRIGATED ABLATION CATHETER, AN INTELLAMAP ORION HIGH RESOLUTION MAPPING CATHETER, TWO EP-XT DIAGNOSTIC CATHETERS AND TWO NON-BOSTON SCIENTIFIC SHEATHS, THE PATIENT EXPERIENCED A HIGH FEVER AND WAS DIAGNOSED WITH AN AMBIGUOUS INFECTION. THE PATIENT WAS GIVEN UNACID 3G INTRAVENOUSLY (IV) ON (B)(6) 2019, CEFIREXON 2G IV ON (B)(6) 2019 AND ZOPICLON 7.5MG ORALLY ON (B)(6) 2019. THE EVENT RESOLVED ON (B)(6) 2019.

  Patient problems: Fever; Unspecified Infection

  MAUDE report 9756638 ↗
• InjuryFeb 26, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL STUDY (B)(6). IT WAS REPORTED THE PATIENT EXPERIENCED A FEVER AND INFECTION. ON (B)(6) 2019, AFTER AN ABLATION PROCEDURE WITH AN INTELLANAV MIFI OPEN-IRRIGATED ABLATION CATHETER, AN INTELLAMAP ORION HIGH RESOLUTION MAPPING CATHETER, TWO EP-XT DIAGNOSTIC CATHETERS AND TWO NON-BOSTON SCIENTIFIC SHEATHS, THE PATIENT EXPERIENCED A HIGH FEVER AND WAS DIAGNOSED WITH AN AMBIGUOUS INFECTION. THE PATIENT WAS GIVEN UNACID 3G INTRAVENOUSLY (IV) ON (B)(6) 2019, CEFIREXON 2G IV ON (B)(6) 2019 AND ZOPICLON 7.5MG ORALLY ON (B)(6) 2019. THE EVENT RESOLVED ON (B)(6) 2019.

  Patient problems: Fever; Unspecified Infection

  MAUDE report 9756623 ↗