Bivona CM1930NRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 15019517033427), received between Apr 20, 2017 and Apr 28, 2017 — classified as 1 injury, 2 malfunctions.

The most frequently reported specific device problem is “Hole In Material” (2 reports).

1 other recall cover devices cleared under the same FDA submission (K923878); 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 18, 2026.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 28, 2017Hole In Material; Hole In Material

  IT WAS REPORTED THAT A PORTEX® BIVONA® CUSTOM 8.0 TTS¿ TRACHEOSTOMY TUBE HAD A SMALL HOLE IN THE CUFF. THE HOLE WAS NOTICED AFTER THE VENTILATOR ALARMED DURING THE NIGHT. THE EVENT OCCURRED AT THE PATIENT'S HOME. NO INJURY WAS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6530915 ↗
• InjuryApr 20, 2017Hole In Material; Hole In Material

  IT WAS REPORTED THAT A PORTEX® BIVONA® CUSTOM TRACHEOSTOMY TUBE CUFF HAD A SMALL HOLE. THE ISSUE WAS SPONTANEOUSLY OBSERVED BY THE PATIENT'S PARENTS DURING THE NIGHT AT THE PATIENT'S HOME. THE DEVICE HAD BEEN IN USE FOR 2 WEEKS PRIOR TO THE EVENT. IT WAS NOTED THAT THE CUFF PATENCY WAS TESTED PRIOR TO USE AND THE CUFF WAS FILLED WITH 8ML OF STERILE WATER. THE TRACHEOSTOMY TUBE WAS EXCHANGED FOR A NEW ONE. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6508899 ↗
• MalfunctionApr 20, 2017Burst Container or Vessel; Burst Container or Vessel

  IT WAS REPORTED THAT A PORTEX® BIVONA® CUSTOM 8.0 MM TTS¿ TRACHEOSTOMY TUBE BURST SPONTANEOUSLY DURING THE NIGHT. THE DEVICE WAS IN USE WITH THE PATIENT AT HOME. THE TRACHEOSTOMY TUBE HAD BEEN IN USE FOR TWO WEEKS. THE PATIENT'S PARENTS HEARD THE ALARM AND NOTICED THE FAULT. CUFF PATENCY WAS TESTED PRIOR TO USE, AND THE CUFF WAS FILLED WITH 8ML OF STERILE WATER. THE CANNULA WAS EXCHANGED FOR A NEW ONE. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6508895 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K923878. One submission often covers many models, so check the product and lot details in each record.

• Z-0260-2007 · Nov 17, 2006 · Terminated
  Custom 5.5 mm Bivona Uncuffed Hyperflex Tracheostomy Tube, I.D. 5.5 mm, O.D. 8.0 mm, length 4.75 mm, Mfrd by Smiths Medical Critical Care; REF HU05JS55NNA112S.