NEUWAVE FLEX4Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00853719006319), received between Dec 21, 2018 and Apr 21, 2022 — classified as 1 death, 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

Recent adverse event reports

The 2 most recent of 2 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 14166623 ↗
• DeathDec 21, 2018Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED VIA CLINICAL TRIAL PATIENT (B)(6) THAT DURING A LUNG LESION FLEX ABLATION PROCEDURE, PATIENT EXPERIENCED BLEEDING DURING NAVIGATION. FOLLOWING THE PROCEDURE, THE PATIENT EXPERIENCED ABLATION SYNDROME, HEMOPTYSIS, AND HEMORRHAGE- NOS.

  Patient problems: Death; Hemorrhage/Blood Loss/Bleeding

  MAUDE report 8189201 ↗