Certus® 140 2.45 GHz Ablation System (REF PR20cm - 17ga)Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00853719006012), received between Aug 2, 2017 and Aug 2, 2017 — classified as 1 injury.

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 18, 2026.

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryAug 2, 2017Adverse Event Without Identified Device or Use Problem

  ON (B)(6), DR. (B)(6) NOTIFIED A NEUWAVE TERRITORY MANAGER THAT THE FEMALE PATIENT THAT HE PERFORMED A NEUWAVE RENAL MWA ON (B)(6) HAD EXPERIENCED SIGNIFICANT INTERNAL BLEEDING 5 HOURS POST ABLATION, THAT SHE HAD CODED AND WAS STABILIZED IN THE UNIT AFTER LOSING LARGE AMOUNTS OF BLOOD. THE CASE INVOLVED THE USE OF 2 PR 20CM PROBES. THE FIRST INVOLVED THE USE OF A 13GA INTRODUCER TO FACILITATE PROBE PLACEMENT. BOTH PROBES WERE ABLATED AT 65W FOR 10 MINUTES TO TREAT A 3.1CM LESION. UPON COMPLETING THE ABLATION, THE PHYSICIAN PERFORMED TRACT CAUTERY WHEN HE REMOVED THE PROBES FROM THE PATIENT. THE CASE WAS COMPLETED WITHOUT INCIDENT. NO DEVICE MALFUNCTION IS ALLEGED.

  Patient problems: Blood Loss; Cardiac Arrest

  MAUDE report 6762241 ↗