NIM FLEX™ 8229980Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 20643169358823), received between Jun 9, 2017 and Aug 27, 2018 — classified as 2 injuries.

The most frequently reported specific device problem is “Partial Blockage” (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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryAug 27, 2018Unable to Obtain Readings; Use of Device Problem; Unable to Obtain Readings; Use of Device Problem

  A HEALTH CARE PROVIDER (HCP) REPORTED VIA A MANUFACTURER REPRESENTATIVE THAT THE RED CIRCUIT OF THE TUBE WAS NOT WORKING DURING A THYROIDECTOMY PROCEDURE. THE HCP NEEDED TO REMOVE THE TUBE AND RE-INTUBATE WITH ANOTHER DEVICE. THE PATIENT WAS RE-INTUBATED, WHICH DID CAUSE A DELAY AND POTENTIAL COMPLICATION TO PATIENT; HOWEVER, THE CASE WENT WELL. THE RED CIRCUIT KEPT SHOWING A CROSS WHEN CONNECTED. THE HCP TRIED THE RED LEAD IN THE BLUE SOCKET AND IT SHOWED A TICK THEN SWAPPED THEM OVER AND SHOWED A CROSS AGAIN PROVING IT WAS THE RED LEAD THAT WAS FAULTY. THERE WAS A NO "ELECTRODE OFF" SHOWED AT ANY TIME.

  Patient problems: Extubate

  MAUDE report 7820153 ↗
• InjuryJun 9, 2017Partial Blockage; Partial Blockage

  WHEN PREPARING FOR A THYROIDECTOMY, THE ANESTHESIOLOGIST TESTED THE NIM FLEX EMG TUBE FOR PATENCY; IT WORKED AS EXPECTED. THE PATIENT WAS INTUBATED WITH THE EMG TUBE IN THE INDUCTION ROOM PRIOR TO SURGICAL INCISION; 5-7 ML OF AIR WAS USED TO INFLATE THE CUFF, AND PRESSURE READING OF THE CUFF MEASURED WITH A MANOMETER READ 30 MBAR. ¿FOR ANESTHESIA USUAL NARCOTICS WERE USED, NO PROBLEMS OCCURRED DURING INTUBATION OF THE TUBE. THEN THEY BLOCKED [CHECKED] THE TUBE ON BOTH SIDES THE SAME BREATH SOUNDS, BUT IT SOUNDS NOT WELL. THE TEAM RELOCKED [DEFLATED AND INFLATED] THE TUBE AND THEY TRY TO FIND OUT WAS WRONG. FIRST THE TEAM WAS THINKING ABOUT PROBLEMS WITH THE NARCOTICS. BUT AFTER UNLOCKING [DEFLATING] THE STATUS OF THE PATIENT WAS BETTER. THEY BLOCKED [INFLATED] AGAIN AND GOT WRONG BREATH SOUNDS AGAIN.¿ THEY THEN USED A LARYNGOSCOPY SYSTEM TO SEE IF THERE WERE PROBLEMS WITHIN THE TUBE. THE TEAM SAW THAT THE INSIDE LUMEN OF THE TUBE WAS BLOCKED. THEY THEN ¿DECIDED TO CHANGE THE TUBE; NO MORE PROBLEMS OCCURRED. THE PATIENT WAS OXYGENATED THE WHOLE TIME, SO THERE ARE NO NEGATIVE CONSEQUENCES FOR THE PATIENT.¿

  Patient problems: Extubate

  MAUDE report 6629576 ↗

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-