NIM FLEX™ 8229965Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 20643169358793), received between Dec 6, 2017 and Oct 15, 2019 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Obstruction of Flow” (2 reports).

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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryOct 15, 2019Obstruction of Flow; Obstruction of Flow

  A HEALTHCARE PROVIDER (HCP) REPORTED VIA A DISTRIBUTOR THAT THE ANESTHESIOLOGIST INTUBATED THE PATIENT WITH STIMULATION CANNULA WHICH WAS DELIVERED AT THE FACILITY A DAY BEFORE. AFTER APPROXIMATELY 30 MINUTES, OVERALL ANESTHESIA IN THE PATIENT DECREASED RESPIRATORY VOLUME AND INCREASED AIRWAY PRESSURE. DURING THE INSPECTION OF THE TUBE, IT WAS FOUND THAT THE INNER LUMEN OF THE CANNULA WAS OBSTRUCTED AT A DISTANCE OF 26-28 CM. THE PATIENT WAS THEN RE-INTUBATED WITH A NEW TUBE. AFTER PERFORMING THE VISUAL INSPECTION, IT WAS FOUND THAT WHEN INFLATING THE CANNULA CUFF, THE INNER LUMEN OF THE CANNULA SEPARATES THE INNER LINING OF THE CANNULA, CREATING A BULGE PREVENTING VENTILATION OF THE PATIENT AS IT COMPLETELY OBSTRUCTS THE TUBE. THE PROCEDURE WAS COMPLETED USING A BACK-UP DEVICE. THE PATIENT WAS ALIVE WITH NO INJURY.

  Patient problems: Airway Obstruction; Extubate

  MAUDE report 9191046 ↗
• MalfunctionDec 6, 2017Deflation Problem; Obstruction of Flow; Deflation Problem; Obstruction of Flow

  THE CUSTOMER REPORTED "THERE WAS (O) HERNIA BLOCKING THE BALLOON WHEN IT WAS REMOVED". THE EMG TUBE WAS REMOVED WITHOUT THE CUFF BEING FULLY DEFLATED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7086083 ↗

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-