Evident VT1737Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10884524000671), received between Feb 27, 2018 and Nov 27, 2018 — classified as 1 injury, 2 malfunctions.

The most frequently reported specific device problem is “Break” (2 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, 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 16, 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.

• InjuryNov 27, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, A 2.8 CM LUNG TUMOR WAS ABLATED WITH 3 OVERLAPPING 10 MINUTES AT 45 WATTS CYCLES WITHOUT IMMEDIATE COMPLICATIONS. 4 WEEKS AFTER THE ABLATION OF THE TUMOR WITH THE EVIDENT SYSTEM A LUNG EMPYEMA OCCURRED AS COMPLICATION. A THORACOSCOPIC REMOVAL OF THE SEQUESTERED TUMOR WHICH WAS IN THE PLEURAL CAVITY WAS PERFORMED. THE FOLLOWING PATHOLOGICAL INVESTIGATION OF THE SPECIMEN SHOWED 70% VIABLE TUMOR CELLS OF A LUNG ADENOCARCINOMA NEAR NECROTIC TISSUE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8109139 ↗
• MalfunctionAug 8, 2018Break; Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, WHILE THE ANTENNA WAS PLACED INTO THE LIVER TUMOR AND WHEN THE PHYSICIAN REPOSITIONED THE NEEDLE WITHIN THE LIVER, THE ANTENNA TIP BROKE. ALL PARTS OF IT WERE COMPLETELY REMOVED FROM THE PATIENT'S BODY. A NEW SIMILAR ANTENNA WAS USED IN ORDER TO FINISH THE PROCEDURE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7762940 ↗
• MalfunctionFeb 27, 2018Break; Break

  ACCORDING TO THE REPORTER, DURING ABLATION, THE DEVICE BROKE WHEN PLACING IT ON THE RIBS. NEW DEVICE WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7300757 ↗