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NEUWAVE FLEX6Recalls & reported problems

Neuwave Medical, Inc. · NEUWAVE Flex Probe 6 · Class 2

Adverse event reports
1
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00853719006326), received between Apr 21, 2022 and Apr 21, 2022 — classified as 1 malfunction.

The most frequently reported specific device problem is “Biocompatibility” (1 report).

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

Device problems

  • Adverse Event Without Identified Device or Use Problem1
  • Appropriate Device Problem Term/Code Not Available1
  • Biocompatibility1

Patient problems

  • Bone Fracture(s)1
  • Pain1

Recent adverse event reports

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

  • MalfunctionApr 21, 2022Biocompatibility; Adverse Event Without Identified Device or Use Problem; Appropriate Device Problem Term/Code Not Available; Biocompatibility; Adverse Event Without Identified Device or Use Problem; Appropriate Device Problem Term/Code Not Available

    TITLE: AUGMENTED FLUOROSCOPY GUIDED TRANSBRONCHIAL PULMONARY MICROWAVE ABLATION USING A STEERABLE SHEATH AUTHORS: MARIO GHOSN, AHMED S. ELSAKKA, FOURAT RIDOUANI, RAPHAEL DOUSTALY, LOUIE MINGIONE, KEVIN ROYALTY, ETAY ZIV, ERICA ALEXANDER, AARON MAXWELL, SEBASTIEN MONETTE, HYUN S. KIM, ROBERT F. SHORT, ALDA LUI TAM, ROBERT D. SUH, STEPHEN B. SOLOMON CITATION: TRANSL LUNG CANCER RES 2022;11(2):150-164 / HTTPS://DX.DOI.ORG/10.21037/TLCR-21-864 THE AIM OF THIS PROSPECTIVE STUDY WAS TO EVALUATE FEASIBILITY AND ACCURACY OF AUGMENTED FLUOROSCOPY GUIDED TRANSBRONCHIAL MICROWAVE ABLATION WITH A STEERABLE SHEATH AND WITHOUT A BRONCHOSCOPE. TO SIMULATE EXTRA-BRONCHIAL LUNG TUMORS, 2 SYNTHETIC TARGETS WERE PLACED PERCUTANEOUSLY FOR EACH PIG IN SEPARATE LOBES AND OUTSIDE THE AIRWAYS. 9 YORKSHIRE PIGS (6 FEMALES AND 3 MALES WITH A MEAN AGE OF 3.5 MONTHS) WERE INCLUDED IN THE STUDY. 18 SYNTHETIC TARGETS WITH A MEDIAN LARGEST DIAMETER OF 9 MM (INTERQUARTILE RANGE, 7¿11 MM) WERE ABLATED. ENDOBRONCHIAL ACCESS WAS OBTAINED THROUGH A 3.5-MM LAPAROSCOPIC TROCAR OR A 5-MM ENDOPATH XCEL BLADELESS TROCAR (ETHICON) PLACED IN A T-CONNECTOR CONNECTED TO THE ENDOTRACHEAL TUBE. A 6.5 FR STEERABLE SHEATH (NON- E

    Patient problems: Bone Fracture(s); Pain

    MAUDE report 14166691 ↗

Other SYSTEM, ABLATION, MICROWAVE AND ACCESSORIES devices

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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.