Evident VTGENRecalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10884524001579), received between Jan 14, 2019 and Feb 12, 2019 — classified as 3 injuries, 3 malfunctions.

1 other recall cover devices cleared under the same FDA submission (K011676); 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 12, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO LITERATURE SOURCE OF STUDY PERFORMED MARCH 2017 AND DECEMBER 2017, THERE WERE NO DEATHS OF ANY OF PATIENTS WHO UNDERWENT MWA. HOWEVER, ONE PATIENT EXPERIENCED AN ADRENAL GLAND-INDUCED TAKOTSUBO (STRESS) CARDIOMYOPATHY IMMEDIATELY AFTER MWA. ADDITIONALLY, ONE SUBDIAPHRAGMATIC HCC NODULE ABLATION WAS COMPLICATED BY A PLEURAL EFFUSION, AND ABLATION OF A HCC NODULE NEAR THE BILE DUCT WAS COMPLICATED BY A BILOMA, DIAGNOSED BY CT AFTER THE ABLATION. THESE COMPLICATIONS WERE RESOLVED BY CONSERVATIVE MEDICAL TREATMENT. REGARDING THE TAKOTSUBO CARDIOMYOPATHY, AUTHORS STATE THAT ¿IT WAS ASSOCIATED WITH MICROWAVE ABLATION WAS NOTED IN (B)(6) YEAR-OLD PATIENT WITH HCC LOCATED IN LIVER LOBE S7 RECEIVED MWA ABLATION. THE DIAMETER OF THE TUMOR WAS 45.1 MM IN THE LONG-AXIS DIAMETER41.1 MM IN THE SHORT-AXIS DIAMETER, AND 40.2 MM IN THE VERTICAL AXIS DIAMETER. THE MWA ANTENNA WAS INSERTED PERCUTANEOUSLY BY AN EXPERT IN LOCAL HCC TREATMENT. THE PATIENT HAD SEVERE HYPERTENSION (SYSTOLIC BLOOD PRESSURE/DIASTOLIC BLOOD PRESSURE, 264/133 MMHG) DURING THE MWA (APPROXIMATELY 9 MIN ABLATED BY 100 W) FOLLOWING VENTRICULAR TACHYCARDIA DESPITE DISCONTINUATION OF THE ABLATION. CARDIAC CATHETERIZATI

  Patient problems: Cardiomyopathy

  MAUDE report 8332035 ↗
• InjuryJan 14, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE LITERATURE SOURCE OF STUDY PERFORMED ON 2015, THIS RETROSPECTIVE STUDY INVESTIGATES OUTCOMES AND PATTERNS OF RECURRENCE IN PATIENTS (N=33) WHO UNDERWENT INTRAOPERATIVE MICROWAVE ABLATION OF COLORECTAL CANCER LIVER METASTASES. MAJOR COMPLICATIONS OCCURRED IN 24% (8/33); THESE PATIENTS ALL HAD CONCOMITANT RESECTION. IN THE EIGHT PATIENTS WHO EXPERIENCED MAJOR COMPLICATION, THE MOST COMMON COMPLICATION WAS AN INTRA-ABDOMINAL ABSCESS REQUIRING INTERVENTIONAL RADIOLOGY-GUIDED DRAINAGE IN 12% (4/33 PATIENTS). THE AUTHORS NOTED COMPLICATIONS DIRECTLY RELATED TO MWA: FOR 1 PATIENT (3%) PERIHEPATIC ABSCESSES NEAR ABLATED AREAS REQUIRED DRAINAGE, AND FOR 1 PATIENT (3%) BILIARY DRAINAGE FROM AN MWA PROBE SITE REQUIRED ONGOING CONTROL, WITH THE BILE LEAK ULTIMATELY TREATED WITH ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY.

  Patient problems: No Code Available

  MAUDE report 8246097 ↗
• MalfunctionJan 14, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE LITERATURE SOURCE PERFORMED. AFTER BEING TREATED OF MICROWAVE (MW) ABLATION OF LUNG TUMORS ASYMPTOMATIC GRADE-1 PNEUMOTHORAX WAS RECORDED IN 9 PATIENTS (37.5 %). ONE CASE OF ASYMPTOMATIC PLEURAL EFFUSION AND ONE OF HAEMOPTYSIS, NOT REQUIRING TRANSFUSION, WERE OBSERVED.

  Patient problems: Hemoptysis; Pleural Effusion; Pneumothorax

  MAUDE report 8246052 ↗
• MalfunctionJan 14, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO LITERATURE SOURCE OF STUDY PERFORMED 25 JUNE 2016,THIS IS A RETROSPECTIVE STUDY TO ANALYZE THE SAFETY AND EFFICACY OF RADIOFREQUENCY ABLATION (RFA) VERSUS MICROWAVE ABLATION (MWA) IN THE TREATMENT OF UNRESECTABLE COLORECTAL LIVER METASTASES (CRLM) IN PROXIMITY TO LARGE VESSELS AND/ OR MAJOR BILE DUCTS. FOR MWA, THEY USED 3.7- CM MICROWAVE ANTENNA(S) (EVIDENT, COVIDIEN, DUBLIN, IRELAND). COMPLICATIONS FOR PATIENTS WITH MWA WERE AS FOLLOWS: RELATED TO PROBE INJURY AND OCCURRING IN 3.1% (1/32 LESIONS) EACH: PNEUMOTHORAX, HEPATIC HEMORRHAGE; RELATED TO THERMAL INJURY AND OCCURRING IN 3.1% (1/32 LESIONS) EACH: FEVER, PAIN AND FEVER, SUBPHRENICAL ABSCESS, BILIARY OBSTRUCTION, AND BILIOPLEURAL FISTULA; RELATED TO THE GENERAL PROCEDURE AND OCCURRING IN 3.1% (1/32 LESIONS) EACH: URINARY TRACT INFECTION, PLEXUS BRACHIALIS NEURALGIA, AND BENIGN CARDIAC ARRYTHMIA; AND RELATED TO THERMAL INJURY AND OCCURRING IN 6.2% (2/32 LESIONS): BILOMA/BILIARY LEAKAGE.

  Patient problems: Abscess; Burn, Thermal; Fistula; Obstruction/Occlusion; Urinary Tract Infection

  MAUDE report 8245919 ↗
• MalfunctionJan 14, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO LITERATURE SOURCE OF STUDY PERFORMED FOR 12 MONTHS, 1 MONTH AFTER BEING TREATED WITH ABLATION, 1 PATIENT SUFFERED FROM MILD PANCREATITIS.

  Patient problems: No Code Available

  MAUDE report 8243276 ↗
• InjuryJan 14, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO LITERATURE SOURCE OF STUDY PERFORMED FOR 12 MONTHS, 1 MONTH AFTER BEING TREATED WITH ABLATION,1 PATIENT EXHIBITED A PROGRESSIVE DISEASE, ONE PATIENT WAS TREATED PERCUTANEOUSLY HAD A GASTRODUODENAL ARTERY PSEUDOANEURYSM RELATED TO ESCHAR HEALING AND 1 HAD A MILD PANCREATITIS THAT REQUIRED DRAINAGE.

  Patient problems: No Code Available

  MAUDE report 8243273 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K011676. One submission often covers many models, so check the product and lot details in each record.

• Z-3092-2011 · Feb 6, 2009 · Terminated
  Evident MWA Generator, REF VTGEN, Output: 60 W / 50 Ohm, Valleylab, a division of Tyco Healthcare Group LP Boulder, CO 80301. Intended for the coagulation of soft tissue. Not inte