NIM FLEX™ 8229985Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 20643169358830), received between Nov 20, 2018 and Nov 20, 2018 — classified as 1 injury.

The most frequently reported specific device problem is “Peeled/Delaminated” (1 report).

3 other recalls cover devices cleared under the same FDA submission (K925640); 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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryNov 20, 2018Peeled/Delaminated; Peeled/Delaminated

  A HEALTH CARE PROVIDER (HCP) REPORTED VIA A MANUFACTURER REPRESENTATIVE THAT THE TUBE WAS ROUTINELY PLACED BY THE ANESTHESIOLOGIST PRIOR TO THE THYROID PROCEDURE. THE INTUBATION WAS USED NORMALLY WITHOUT ANY PROBLEMS. HOWEVER, SHORTLY BEFORE THE PATIENT WAS THEN PLACED IN THE OPERATING ROOM, THERE WAS AN INCREASE OF THE VENTILATION PRESSURE. THE VENTILATION PRESSURE WAS NOTICED AFTER THE AIRWAY WAS ESTABLISHED. SO, THE ANESTHESIOLOGIST DECIDED TO EXTUBATE THE TUBE AND INTUBATE THE PATIENT AGAIN WITH ANOTHER NEW TUBE. THE DELAY TIME WAS ONLY WHEN THE EXTUBATION AND THE NEW INTUBATION OF THE TUBE. THEN ALL WAS FINE AND THE THYROID PROCEDURE WAS PERFORMED WITHOUT ANY PROBLEMS. THERE WAS NO PATIENT IMPACT AFTER THE PROCEDURE AS STATUS OF PATIENT WAS ALIVE WITH NO INJURY.

  Patient problems: Extubate; Occlusion

  MAUDE report 8091032 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K925640. One submission often covers many models, so check the product and lot details in each record.

• Z-1520-2022 · Apr 29, 2022 · Open, Classified
  NIM EMG Endotracheal Tube, Part Numbers: a) REF 8229308 b) REF 8229307 c) REF 8229306
• Z-0901-2017 · Jun 28, 2016 · Terminated
  NIM EMG Endotracheal Tube, 6.0 mm I.D. x 8.8 mm O.D. (27 FR), Reinforced, Sterile, Rx only. Individually packaged.
• Z-0310-05 · Oct 29, 2004 · Terminated
  Brand name: NIM EMG Endotracheal Tube REF 82-29106, 82-29107, 82-29108 NIM EMG Reinforced Endotracheal Tube REF 82-29306, 82-