NIM FLEX™ 8229970Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 20643169358809), received between Dec 21, 2017 and Nov 26, 2019 — classified as 6 injuries, 5 malfunctions.

The most frequently reported specific device problem is “Partial Blockage” (4 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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 26, 2019Use of Device Problem; Use of Device Problem

  A HEALTHCARE PROFESSIONAL (HCP) REPORTED THAT THE NERVE MONITORING FOR THE TUBE WORKED FOR THE FIRST PART OF THE OPERATION AND THEN STOPPED WORKING DURING A RECURRENT LARYNGEAL NERVE MONITORING CASE. ALL CONNECTIONS AND TUBE PLACEMENT WERE CHECKED - STILL NOT WORKING. ANAESTHETIST CHANGED TO A NEW TUBE WHICH WORKED. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9376358 ↗
• MalfunctionJun 19, 2019Material Separation; Material Separation

  A HEALTHCARE PROVIDER (HCP) REPORTED THAT VIA A DISTRIBUTOR THAT DURING A THYROIDECTOMY PROCEDURE, THE TUBE WAS POSITIONED AT THE PATIENT AND SUDDENLY THE ELECTRODE PART DETACHED AND FELL. THEY CONTINUED USING THE TUBE WITHOUT THE ELECTRODE AND USING CHEANG¿S METHOD TO DO MONITORING. THERE WAS NO PATIENT IMPACT OR INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8714466 ↗
• InjuryMay 6, 2019Partial Blockage; Partial Blockage

  A HEALTHCARE PROFESSIONAL (HCP) REPORTED THAT THERE WAS INCREASING DIFFICULTY VENTILATING THE PATIENT DURING THYROID SURGERY. BRONCHOSCOPY REVEALED INNER HERNIATION OF ENDOTRACHEAL TUBE INTO LUMEN OF THE TUBE OBSTRUCTING VENTILATION. THE DEVICE WAS CHANGED AND PROBLEM WAS RESOLVED. THE PROCEDURE WAS COMPLETED WITH NO DELAY. THERE WAS NO PATIENT INJURY.

  Patient problems: Airway Obstruction

  MAUDE report 8583889 ↗
• MalfunctionJan 11, 2019False Positive Result; False Positive Result

  ADDITIONAL INFORMATION STATED THAT THE ANARCHIC SIGNAL MEANT ARTIFACT; THE WAVES ON THE SCREEN. THE ANESTHETIC DRUG USED ON THE PATIENT WAS PROPOFOL WITH SEVOFLURANE GAS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8241256 ↗
• MalfunctionNov 28, 2018Unable to Obtain Readings; Unable to Obtain Readings

  ADDITIONAL INFORMATION RECEIVED STATED THAT DURING THE CHECK UP FOR TUBE POSITION AFTER THE AIRWAY WAS ESTABLISHED, IN CONTROL OF ELECTRODE PART, ALL CROSSES WERE RED WHEREAS THE TUBE WAS CORRECTLY POSITIONED AND CABLES WIRED; THE PATIENT INTERFACE AND RETURN ELECTRODES ON PATIENT BREAST, TOO. A SECOND TUBE WAS USED BUT, THE ISSUE WAS NOT RESOLVED. THEN, TOOK A THIRD TUBE WITH A DIFFERENT LOT NUMBER AND FINALLY, ALL THE CROSSES BECAME GREEN. THEY LOST TIME BUT THERE WAS NO PATIENT IMPACT AND THE CASE WAS COMPLETED. THE ISSUE REPEATED ALL WEEK WHEN TUBE IN THE SAME LOT NUMBER WAS USED; EVEN WITH THE SAME MAINFRAME AND DIFFERENT MEDICAL STAFF.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8112005 ↗
• InjuryNov 15, 2018Partial Blockage; Use of Device Problem; Fitting Problem; Partial Blockage; Use of Device Problem; Fitting Problem

  A HEALTHCARE PROFESSIONAL (HCP) REPORTED VIA A MANUFACTURER REPRESENTATIVE THAT THE TUBE DID NOT WORK PROPERLY DURING A PROCEDURE. THE HCP MENTIONED THAT IT SEEMED THAT THE BALLOON WAS LOOSE. AFTER 20 MINUTES, THE TUBE STARTED TO OBTURATE AND THE INNER LUMEN WAS CLOSED UNDER PRESSURE OF THE BALLOON. AFTER 30 MINUTES, THE TUBE WAS CHANGED SINCE THE PATIENT WAS NOT VENTILATED.

  Patient problems: Airway Obstruction; Extubate

  MAUDE report 8073625 ↗
• InjuryNov 15, 2018Partial Blockage; Use of Device Problem; Fitting Problem; Partial Blockage; Use of Device Problem; Fitting Problem

  A HEALTHCARE PROFESSIONAL (HCP) REPORTED VIA A MANUFACTURER REPRESENTATIVE THAT THE TUBE DID NOT WORK PROPERLY DURING A PROCEDURE. THE HCP MENTIONED THAT IT SEEMED THAT THE BALLOON WAS LOOSE. AFTER 20 MINUTES, THE TUBE STARTED TO OBTURATE AND THE INNER LUMEN WAS CLOSED UNDER PRESSURE OF THE BALLOON. AFTER 30 MINUTES, THE TUBE WAS CHANGED SINCE THE PATIENT WAS NOT VENTILATED.

  Patient problems: Airway Obstruction; Extubate

  MAUDE report 8073555 ↗
• InjuryNov 15, 2018Partial Blockage; Use of Device Problem; Fitting Problem; Partial Blockage; Use of Device Problem; Fitting Problem

  A HEALTHCARE PROFESSIONAL (HCP) REPORTED VIA A MANUFACTURER REPRESENTATIVE THAT THE TUBE DID NOT WORK PROPERLY DURING A PROCEDURE. THE HCP MENTIONED THAT IT SEEMED THAT THE BALLOON WAS LOOSE. AFTER 20 MINUTES, THE TUBE STARTED TO OBTURATE AND THE INNER LUMEN WAS CLOSED UNDER PRESSURE OF THE BALLOON. AFTER 30 MINUTES, THE TUBE WAS CHANGED SINCE THE PATIENT WAS NOT VENTILATED.

  Patient problems: Airway Obstruction; Extubate

  MAUDE report 8073528 ↗
• InjuryMay 1, 2018Occlusion Within Device; Occlusion Within Device

  THE ANESTHESIOLOGIST REPORTED THAT WHILE THE PATIENT WAS INTUBATED DURING A PROCEDURE, AFTER AN HOUR OF BEING INTUBATED, THE NIM EMG TUBE HERNIATED RESULTING IN OCCLUSION OF THE TUBE. THE EMG TUBE AND CUFF WERE CHECKED PRIOR TO USE. THE CUFF WAS INFLATED WITH APPROXIMATELY 8CC OF AIR. THE VENTILATOR GAVE A PRE-WARNING PRESSURE ALARM, EVEN THOUGH TIDAL VOLUME WAS ACCEPTABLE. IN LESS THAN ONE MINUTE, COMPLETE OCCLUSION OF THE TUBE WAS ATTENDED TO AND THE PATIENT WAS RE-INTUBATED WITH A NEW TUBE. THE PATIENT SUFFERED SEVERE APNEA THAT WAS IMMEDIATELY REVERSED WITH ESTABLISHMENT OF THE REPLACEMENT TUBE. THE PATIENT'S CURRENT STATUS IS STABLE; NO INJURY HAS BEEN REPORTED.

  Patient problems: Apnea

  MAUDE report 7478507 ↗
• MalfunctionApr 27, 2018Occlusion Within Device; Occlusion Within Device

  THE DOCTOR REPORTED THAT AFTER THE PROCEDURE, DURING EXTUBATION, THAT THE LUMEN OF THE FLEX EMG TUBE WAS BLOCKED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7469610 ↗
• InjuryDec 21, 2017Device Operates Differently Than Expected; Device Operates Differently Than Expected

  THE ANESTHETIST REPORTED THAT THE TUBE AND CUFF WERE CHECKED FOR PATENCY PRIOR TO INTUBATING THE PATIENT WITH THE NIM FLEX EMG TUBE FOR A THYROIDECTOMY. APPROXIMATELY 30-40 MINUTES INTO THE PROCEDURE THE ANESTHESIOLOGIST NOTED THAT "THE PATIENT DOESN'T BREATHE CORRECTLY". SATURATION, SHALLOW BREATHING AND OTHER PARAMETERS WERE CHECKED; A DECISION WAS MADE TO REINTUBATE THE PATIENT WITH A NEW TUBE TO COMPLETE THE PROCEDURE. THERE WAS NO REPORTED INJURY; THE PROCEDURE WAS SUCCESSFULLY COMPLETED.

  Patient problems: Extubate; Respiratory Distress

  MAUDE report 7137813 ↗

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-