Bivona XT19KS70NSC923NRecalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 15019517212228), received between Apr 10, 2020 and Jul 10, 2020 — classified as 2 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Leak/Splash” (6 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• InjuryJul 10, 2020Leak/Splash; Material Puncture/Hole; Tear, Rip or Hole in Device Packaging; Scratched Material; Leak/Splash; Material Puncture/Hole; Tear, Rip or Hole in Device Packaging; Scratched Material

  INFORMATION RECEIVED A SMITH MEDICAL CUSTOM TRACH WAS INSERTED ON (B)(6) 2020 AND DEVELOPED A HOLE IN THE CUFF ON THE EVENING OF (B)(6) 2020 ,WHICH WAS MAKING THE PATIENT CONTINUOUSLY COUGH. A NEW TRACH WAS PLACED AND THE FOLLOWING DAY DEVELOPED A HOLE IN THE CUFF AS WELL. THIS EVENT OF COUGHING WOULD INCREASE SECRETIONS OF PHLEGM, WHICH MAY PUT THE PATIENT AT RISK FOR ASPIRATION OF SECRETIONS AND FURTHER OBSTRUCTION. NO INJURY WAS REPORTED.

  Patient problems: Airway Obstruction

  MAUDE report 10260507 ↗
• InjuryJul 9, 2020Leak/Splash; Material Puncture/Hole; Tear, Rip or Hole in Device Packaging; Scratched Material; Leak/Splash; Material Puncture/Hole; Tear, Rip or Hole in Device Packaging; Scratched Material

  INFORMATION RECEIVED A SMITH MEDICAL CUSTOM TRACH WAS INSERTED ON (B)(6) 2020 AND DEVELOPED A HOLE IN THE CUFF ON THE EVENING OF (B)(6) 2020 ,WHICH WAS MAKING THE PATIENT CONTINUOUSLY COUGH. A NEW TRACH WAS PLACED AND THE FOLLOWING DAY DEVELOPED A HOLE IN THE CUFF AS WELL. THIS EVENT OF COUGHING WOULD INCREASE SECRETIONS OF PHLEGM, WHICH MAY PUT THE PATIENT AT RISK FOR ASPIRATION OF SECRETIONS AND FURTHER OBSTRUCTION. NO INJURY WAS REPORTED.

  Patient problems: Airway Obstruction

  MAUDE report 10251799 ↗
• MalfunctionApr 14, 2020Leak/Splash; Leak/Splash

  INFORMATION WAS RECEIVED INDICATING THAT THE CUFF TO A SMITHS MEDICAL PORTEX BIVONA FLEXTEND¿ TTS¿ TRACHEOSTOMY TUBE WAS FOUND TO BE LEAKING. A TRACH TUBE CHANGE OUT WAS PERFORMED WITH NO ADVERSE PATIENT EFFECTS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9960349 ↗
• MalfunctionApr 10, 2020Leak/Splash; Material Puncture/Hole; Leak/Splash; Material Puncture/Hole

  INFORMATION WAS RECEIVED INDICATING THAT THE CUFF TO A SMITHS MEDICAL PORTEX BIVONA FLEXTEND¿ TTS¿ TRACHEOSTOMY TUBE WAS FOUND TO BE LEAKING DUE TO A HOLE. SUBSEQUENTLY, A TRACH TUBE CHANGE OUT IMMEDIATELY. THERE WERE NO REPORTED ADVERSE EFFECTS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9948765 ↗
• MalfunctionApr 10, 2020Leak/Splash; Material Puncture/Hole; Leak/Splash; Material Puncture/Hole

  INFORMATION WAS RECEIVED INDICATING THAT THE CUFF TO A SMITHS MEDICAL PORTEX BIVONA FLEXTEND¿ TTS¿ TRACHEOSTOMY TUBE WAS FOUND TO BE LEAKING DUE TO A HOLE. SUBSEQUENTLY, A TRACH TUBE CHANGE OUT IMMEDIATELY. THERE WERE NO REPORTED ADVERSE EFFECTS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9948764 ↗
• MalfunctionApr 10, 2020Leak/Splash; Material Puncture/Hole; Leak/Splash; Material Puncture/Hole

  INFORMATION WAS RECEIVED INDICATING THAT THE CUFF TO A SMITHS MEDICAL PORTEX BIVONA FLEXTEND¿ TTS¿ TRACHEOSTOMY TUBE WAS FOUND TO BE LEAKING DUE TO A HOLE. SUBSEQUENTLY, A TRACH TUBE CHANGE OUT IMMEDIATELY. THERE WERE NO REPORTED ADVERSE EFFECTS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9948760 ↗

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.