NIM® 8229307 (UDI 00643169358713)Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00643169358713), received between Mar 23, 2017 and Aug 9, 2017 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Air Leak” (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. What reports can and can't tell you · How this data works · Data updated Oct 16, 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.

• MalfunctionAug 9, 2017Air Leak; Air Leak

  DURING SET-UP FOR A THYROIDECTOMY/PARATHYROIDECTOMY PROCEDURE, THE PHYSICIAN TESTED THE EMG TUBE FOR PATENCY. AFTER INFLATING THE CUFF THE PHYSICIAN FOUND THAT THE "CUFF OF THE TUBE (THE WHITE PLUG) WAS LEAKING"; THE INFLATION ASSEMBLY. A NEW DEVICE WAS USED FOR THE PROCEDURE. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6776700 ↗
• MalfunctionMar 23, 2017Material Puncture/Hole; Material Puncture/Hole

  IT WAS REPORTED THAT BEFORE THE SURGERY, IT WAS FOUND THAT THE WIRE HAD PUNCTURED THE BALLOON; IT WAS NOT USED ON THE PATIENT. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6429313 ↗

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-