Bivona HT14DS70NSC148SRecalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 10351688765727), received between Aug 8, 2018 and Aug 9, 2019 — classified as 6 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Inflation Problem” (8 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.

• InjuryAug 9, 2019Inflation Problem; Inflation Problem

  INFORMATION WAS RECEIVED INDICATING THAT THE CUFF TO A SMITHS MEDICAL PORTEX BIVONA HYPERFLEX TTS¿ TRACHEOSTOMY TUBE WAS REPORTED TO TAKE LONGER TO INFLATE. THE PATIENT'S MOTHER INDICATED THAT RESISTANCE WAS MET AND HAD TO PUSH HARDER TO INSERT THE WATER; CAUSING DISTRESS AND DISCOMFORT TO THE PATIENT. THE MOTHER REPORTED THAT INFLATION AND DEFLATION OF THE CUFF WAS PERFORMED PRIOR TO INSERTION AND HAD THE SAME DIFFICULTIES. A TRACH TUBE CHANGE OUT WAS NEEDED FOLLOWING PLACEMENT BUT THE CUFF WAS REPORTED TO TAKE LONGER TO DEFLATE. NO FURTHER ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Pain

  MAUDE report 8881007 ↗
• InjuryAug 9, 2019Inflation Problem; Inflation Problem

  INFORMATION WAS RECEIVED INDICATING THAT THE CUFF TO A SMITHS MEDICAL PORTEX BIVONA HYPERFLEX TTS TRACHEOSTOMY TUBE WAS REPORTED TO TAKE LONGER TO INFLATE. THE PATIENT'S MOTHER INDICATED THAT RESISTANCE WAS MET AND HAD TO PUSH HARDER TO INSERT THE WATER; CAUSING DISTRESS AND DISCOMFORT TO THE PATIENT. THE MOTHER REPORTED THAT INFLATION AND DEFLATION OF THE CUFF WAS PERFORMED PRIOR TO INSERTION AND HAD THE SAME DIFFICULTIES. A TRACH TUBE CHANGE OUT WAS NEEDED FOLLOWING PLACEMENT BUT THE CUFF WAS REPORTED TO TAKE LONGER TO DEFLATE. NO FURTHER ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Pain

  MAUDE report 8880975 ↗
• InjuryAug 9, 2019Inflation Problem; Inflation Problem

  INFORMATION WAS RECEIVED INDICATING THAT THE CUFF TO A SMITHS MEDICAL PORTEX BIVONA HYPERFLEX TTS TRACHEOSTOMY TUBE WAS REPORTED TO TAKE LONGER TO INFLATE. THE PATIENT'S MOTHER INDICATED THAT RESISTANCE WAS MET AND HAD TO PUSH HARDER TO INSERT THE WATER; CAUSING DISTRESS AND DISCOMFORT TO THE PATIENT. THE MOTHER REPORTED THAT INFLATION AND DEFLATION OF THE CUFF WAS PERFORMED PRIOR TO INSERTION AND HAD THE SAME DIFFICULTIES. A TRACH TUBE CHANGE OUT WAS NEEDED FOLLOWING PLACEMENT BUT THE CUFF WAS REPORTED TO TAKE LONGER TO DEFLATE. NO FURTHER ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Pain

  MAUDE report 8880963 ↗
• InjuryAug 9, 2019Inflation Problem; Inflation Problem

  INFORMATION WAS RECEIVED INDICATING THAT THE CUFF TO A SMITHS MEDICAL PORTEX BIVONA HYPERFLEX TTS¿ TRACHEOSTOMY TUBE WAS REPORTED TO TAKE LONGER TO INFLATE. THE PATIENT'S MOTHER INDICATED THAT RESISTANCE WAS MET AND HAD TO PUSH HARDER TO INSERT THE WATER; CAUSING DISTRESS AND DISCOMFORT TO THE PATIENT. THE MOTHER REPORTED THAT INFLATION AND DEFLATION OF THE CUFF WAS PERFORMED PRIOR TO INSERTION AND HAD THE SAME DIFFICULTIES. A TRACH TUBE CHANGE OUT WAS NEEDED FOLLOWING PLACEMENT BUT THE CUFF WAS REPORTED TO TAKE LONGER TO DEFLATE. NO FURTHER ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Pain

  MAUDE report 8880940 ↗
• InjuryAug 9, 2019Inflation Problem; Inflation Problem

  INFORMATION WAS RECEIVED INDICATING THAT THE CUFF TO A SMITHS MEDICAL PORTEX BIVONA HYPERFLEX TTS¿ TRACHEOSTOMY TUBE WAS REPORTED TO TAKE LONGER TO INFLATE. THE PATIENT'S MOTHER INDICATED THAT RESISTANCE WAS MET AND HAD TO PUSH HARDER TO INSERT THE WATER; CAUSING DISTRESS AND DISCOMFORT TO THE PATIENT. THE MOTHER REPORTED THAT INFLATION AND DEFLATION OF THE CUFF WAS PERFORMED PRIOR TO INSERTION AND HAD THE SAME DIFFICULTIES. A TRACH TUBE CHANGE OUT WAS NEEDED FOLLOWING PLACEMENT BUT THE CUFF WAS REPORTED TO TAKE LONGER TO DEFLATE. NO FURTHER ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Pain

  MAUDE report 8880921 ↗
• InjuryAug 9, 2019Inflation Problem; Inflation Problem

  INFORMATION WAS RECEIVED INDICATING THAT THE CUFF TO A SMITHS MEDICAL PORTEX PORTEX BIVONA HYPERFLEX TTS¿ TRACHEOSTOMY TUBE WAS REPORTED TO TAKE LONGER TO INFLATE. THE PATIENT'S MOTHER INDICATED THAT RESISTANCE WAS MET AND HAD TO PUSH HARDER TO INSERT THE WATER; CAUSING DISTRESS AND DISCOMFORT TO THE PATIENT. THE MOTHER REPORTED THAT INFLATION AND DEFLATION OF THE CUFF WAS PERFORMED PRIOR TO INSERTION AND HAD THE SAME DIFFICULTIES. A TRACH TUBE CHANGE OUT WAS NEEDED FOLLOWING PLACEMENT BUT THE CUFF WAS REPORTED TO TAKE LONGER TO DEFLATE. NO FURTHER ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Pain

  MAUDE report 8880901 ↗
• MalfunctionAug 9, 2018Inflation Problem; Inflation Problem

  INFORMATION WAS RECEIVED INDICATING THAT A CUFF TO A SMITHS MEDICAL PORTEX BIVONA FLEXTEND¿ TTS¿ TRACHEOSTOMY TUBE WOULD NOT INFLATE DURING PRE-USE CHECK. THERE WERE NO REPORTED ADVERSE EFFECTS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7768076 ↗
• MalfunctionAug 8, 2018Inflation Problem; Inflation Problem

  INFORMATION WAS RECEIVED INDICATING THAT A CUFF TO A SMITHS MEDICAL PORTEX BIVONA FLEXTEND¿ TTS¿ TRACHEOSTOMY TUBE WOULD NOT INFLATE DURING PRE-USE CHECK. THERE WERE NO REPORTED ADVERSE EFFECTS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7764659 ↗

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.