Bivona HT14KS60NSC287SRecalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 15019517022605), received between Jun 12, 2018 and Sep 24, 2022 — classified as 4 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Defective Device” (3 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 24, 2022Defective Device; Defective Device

  IT WAS REPORTED THAT THERE WAS FUZZ VISIBLE IN CUFF. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15476361 ↗
• MalfunctionSep 22, 2022Defective Device; Defective Device

  IT WAS REPORTED THAT THERE WAS FUZZ VISIBLE IN CUFF. NO PATIENT INJURY WAS REPORTED

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15468997 ↗
• MalfunctionSep 22, 2022Defective Device; Defective Device

  IT WAS REPORTED THAT THERE WAS FUZZ VISIBLE IN CUFF. NO PATIENT INJURY WAS REPORTED

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15465115 ↗
• MalfunctionMay 22, 2020Contamination; Contamination

  INFORMATION WAS RECEIVED THAT DEVICE HAD FUZZ VISIBLE IN CUFF. TRACHEOSTOMY WAS USED FROM MARCH 3 TO MARCH 21. A TUBE CHANGE OUT OCCURRED AS A RESULT, AND THE INCIDENT WAS THEN REPORTED TO BE RESOLVED. NO ADVERSE EFFECTS REPORTED.

  Patient problems: No Information

  MAUDE report 10083643 ↗
• InjuryOct 3, 2019Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  INFORMATION WAS RECEIVED THAT A SMITHS MEDICAL BIVONA CUSTOM 6.0 TTS HYPERFLEX TRACHEOSTOMY TUBE WAS PLACED WITH A PATIENT ON (B)(6) 2019. ON (B)(6) 2019 IT WAS REPORTED THAT THE PILOT PORT BROKE, EVEN THOUGH THE BALLOON "STILL SEEMS TO HOLD AIR". SUBSEQUENTLY, AN EMERGENCY TUBE CHANGE OUT WAS REQUIRED AND THE PATIENT RECOVERED. THERE WERE NO ADVERSE PATIENT EFFECTS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9153996 ↗
• InjuryAug 8, 2018Material Puncture/Hole; Material Puncture/Hole

  INFORMATION WAS RECEIVED INDICATING THAT 19 DAYS FOLLOWING PLACEMENT OF A SMITHS MEDICAL PORTEX BIVONA FLEXTEND¿ TTS¿ TRACHEOSTOMY TUBE A HOLE WAS NOTED IN THE PILOT LINE. SUBSEQUENTLY, THE TRACHEOSTOMY (TRACH) WAS CHANGED OUT ON A VENTILATOR DEPENDENT PATIENT. THERE WERE NO REPORTED ADVERSE EFFECTS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7762362 ↗
• InjuryJun 12, 2018Cut In Material; Cut In Material

  INFORMATION WAS RECEIVED INDICATING THAT THREE DAYS FOLLOWING PLACEMENT OF A SMITHS MEDICAL PORTEX BIVONA ¿ TTS¿ TRACHEOSTOMY TUBE, A CUT WAS NOTED TO THE PILOT LINE. SUBSEQUENTLY, IT WAS REQUIRED TO PERFORM AN EMERGENT TRACHEOSTOMY (TRACH) CHANGE. THERE WERE NO REPORTED ADVERSE EFFECTS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7594232 ↗
• InjuryJun 12, 2018Break; Break

  INFORMATION WAS RECEIVED INDICATING THAT EIGHT DAYS FOLLOWING PLACEMENT OF A SMITHS MEDICAL PORTEX BIVONA ¿ TTS¿ TRACHEOSTOMY TUBE THE PILOT BALLOON WAS NOTED TO BREAK OFF. SUBSEQUENTLY, IT WAS REQUIRED TO PERFORM AN EMERGENT TRACHEOSTOMY (TRACH) CHANGE. THERE WERE NO REPORTED ADVERSE EFFECTS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7594219 ↗

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.