NIM FLEX™ 8229975Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 20643169358816), received between May 4, 2017 and Sep 28, 2020 — classified as 5 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Device Operates Differently Than Expected” (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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• InjurySep 28, 2020Blocked Connection; Blocked Connection

  A HEALTH CARE PROVIDER (HCP) REPORTED THAT DURING SURGERY, ANAESTHETIST WAS UNABLE TO VENTILATE PATIENT ADEQUATELY AND WHILE TRYING TO PASS A SUCTION CATHETER THROUGH THE TUBE IT WAS FOUND TO BE BLOCKED AS THE CATHETER WOULDN¿T GO IN. WE CHANGED TO ANOTHER TUBE AND RESUMED SURGERY. WHEN EXAMINING THE TUBE, THE INTERNAL LUMEN WAS FOUND BLOCKED WITH BULGING OF THE ARMOUR MATERIAL INTERNALLY ESPECIALLY WHEN BENT.

  Patient problems: Extubate

  MAUDE report 10592200 ↗
• InjuryNov 7, 2018Partial Blockage; Partial Blockage

  A HEALTH CARE PROVIDER (HCP) REPORTED VIA MANUFACTURER REPRESENTATIVE THAT DURING THE INCISION, THERE WAS SUDDENLY RESPIRATORY HYPER PRESSURE AND IMPOSSIBILITY OF VENTILATION. STRONG DESATURATION WAS APPLIED AND THE SURGERY WAS STOPPED IMMEDIATELY. THERE WAS EXTUBATION ON (B)(6) AND REVENTILATION WITH MASK, RE-SATURATION AND RE-INTUBATION ON EISCMAN. IN CONCLUSION AND AFTER CHECKING, THE TUBE HAD AN INTRALUMINAL HERNIA WHEN INFLATING BALLOON. THIS PREVENTED ANY VENTILATION. PATIENT WAS ALIVE-NO INJURY. THERE WAS NO PATIENT IMPACT.

  Patient problems: Extubate; Low Oxygen Saturation; Respiratory Distress

  MAUDE report 8048086 ↗
• InjuryOct 11, 2018Use of Device Problem; Use of Device Problem

  A HEALTH CARE PROVIDER (HCP) REPORTED VIA MANUFACTURER REPRESENTATIVE THAT THE ANESTHETIST REFERRED THAT THE PATIENT DID NOT BREATHE CORRECTLY AFTER INTUBATION DURING THE PROCEDURE. THE TUBE HAD A MALFUNCTION DURING A THYROID PROCEDURE. THEY HAVE USED THE TUBE CORRECTLY AND HAVE CHECKED THE DIFFERENT PARAMETERS OF THE ANESTHESIA WORKSTATION AND DECIDED TO CHANGED FOR ANOTHER TUBE. THE CUFF WAS ABLE TO BE INFLATED AND THE AIRWAY WAS ESTABLISHED. THE NURSE HAD CHECKED THE CUFF BEFORE INTUBATION WITH THE FLEX TUBE. THIS WAS THE INITIAL USE FOR NERVE INTRAOPERATIVE MONITORING. THEY DECIDED TO CHANGE THE TUBE. THERE WAS NO DELAY IN THE PROCEDURE. THERE WAS NO PATIENT IMPACT.

  Patient problems: Dyspnea; Extubate

  MAUDE report 7955912 ↗
• InjuryOct 4, 2018Failure to Read Input Signal; Failure to Read Input Signal

  A HEALTH CARE PROFESSIONAL (HCP) REPORTED VIA A MANUFACTURER REPRESENTATIVE THAT THE ENDOTRACHEAL TUBE WAS USED FOR THE FIRST TIME.

  Patient problems: Extubate

  MAUDE report 7935957 ↗
• MalfunctionOct 11, 2017No Display/Image; Device Operates Differently Than Expected; No Display/Image; Device Operates Differently Than Expected

  ADDITIONAL INFORMATION WAS RECEIVED CONFIRMING THAT ¿THE BREATHING TUBE WAS REPOSITIONED SEVERAL TIMES: NO POSITIVE RESULTS. ALL THE CONNECTING WIRES HAVE BEEN VERIFIED. ANOTHER BREATHING TUBE FROM ANOTHER LOT HAS BEEN USED¿ FOR REINTUBATION AND COMPLETION OF PROCEDURE. ¿AINS [NON-STEROIDAL ANTI-INFLAMMATORIES] WERE PROVIDED AFTERWARD.¿

  Patient problems: Extubate; No Consequences Or Impact To Patient

  MAUDE report 6941657 ↗
• MalfunctionOct 11, 2017No Display/Image; Device Operates Differently Than Expected; No Display/Image; Device Operates Differently Than Expected

  ADDITIONAL INFORMATION WAS RECEIVED CONFIRMING THAT ¿THE BREATHING TUBE WAS REPOSITIONED SEVERAL TIMES: NO POSITIVE RESULTS. ALL THE CONNECTING WIRES HAVE BEEN VERIFIED. ANOTHER BREATHING TUBE FROM ANOTHER LOT HAS BEEN USED¿ FOR REINTUBATION AND COMPLETION OF PROCEDURE. ¿AINS [NON-STEROIDAL ANTI-INFLAMMATORIES] WERE PROVIDED AFTERWARD.¿

  Patient problems: Extubate; No Consequences Or Impact To Patient

  MAUDE report 6941629 ↗
• MalfunctionJun 7, 2017Deflation Problem; Deflation Problem

  THE PHARMACIST FROM THE FACILITY REPORTED THAT ¿WHEN THEY TRIED TO TAKE OUT THE [NIM FLEX EMG] TUBE THE BALLOON DID NOT DEFLATE; THEY HAD TO FORCE THE EXTRACTION.¿ THE TUBE AND CUFF WERE CHECKED FOR PATENCY PRIOR TO INTUBATION, AND WORKED AS EXPECTED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6619478 ↗
• InjuryMay 4, 2017Partial Blockage; Partial Blockage

  PRIOR TO INTUBATING THE PATIENT FOR A TOTAL THYROIDECTOMY, THE PHYSICIAN TESTED THE TUBE FOR PATENCY; THE TUBE PERFORMED AS EXPECTED. THE PHYSICIAN REPORTED USING LESS THAN 10 ML OF AIR TO INFLATE THE CUFF WHEN INTUBATING THE PATIENT. TWENTY MINUTES AFTER STARTING THE SURGERY THERE WAS AN AIRWAY PRESSURE INCREASE. AFTER SEVERAL MINUTES INVESTIGATING THE SOURCE OF THE PROBLEM THE ANAESTHESIOLOGIST DISCOVERED THAT THE SOURCE OF THE PROBLEM WAS BLOCKAGE OF THE INNER LUMEN. FOR THIS REASON THE TUBE WAS CHANGED FOR A NEW ONE. THERE WAS NO PATIENT INJURY.

  Patient problems: Extubate

  MAUDE report 6545692 ↗

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-