Bivona HT14FS70NSC353NRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10351688766038), received between Jul 14, 2020 and Jul 14, 2020 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Inadequacy of Device Shape and/or Size” (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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 14, 2020Material Fragmentation; Inflation Problem; Inadequacy of Device Shape and/or Size; Material Fragmentation; Inflation Problem; Inadequacy of Device Shape and/or Size

  INFORMATION WAS RECEIVED INDICATING THAT THE CUFF TO A SMITHS MEDICAL PORTEX BIVONA CUSTOM TTS STANDARD HYPERFLEX TRACHEOSTOMY TUBE WAS REPORTED TO BE INFLATING ASYMMETRICALLY AND USING TWICE THE AMOUNT OF WATER TO CREATE A SEAL. THE PILOT BALLOON WAS ALSO REPORTED TO BE LEAKING. WHEN THE SYRINGE WAS REMOVED AFTER INFLATION, THE ENTIRE PLASTIC SYRINGE PORT WAS NOTED TO COME OUT OF THE PILOT BALLOON LEADING TO INOPERABILITY OF THE CUFF AND SALINE LEAKING OUT. THE RESPIRATORY THERAPIST WAS THEN ABLE TO PUSH THE PLASTIC PORT BACK INTO THE PILOT BALLOON TO REINSERT INTO THE PATIENT. THERE WAS THEN SOME OBSERVED SALINE LEAKAGE UPON CUFF INFLATION. THERE WERE NO REPORTED ADVERSE PATIENT EFFECTS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10271905 ↗
• MalfunctionJul 14, 2020Material Fragmentation; Inflation Problem; Inadequacy of Device Shape and/or Size; Material Fragmentation; Inflation Problem; Inadequacy of Device Shape and/or Size

  INFORMATION WAS RECEIVED INDICATING THAT THE CUFF TO A SMITHS MEDICAL PORTEX BIVONA CUSTOM TTS STANDARD HYPERFLEX TRACHEOSTOMY TUBE WAS REPORTED TO BE INFLATING ASYMMETRICALLY AND USING TWICE THE AMOUNT OF WATER TO CREATE A SEAL. THE PILOT BALLOON WAS ALSO REPORTED TO BE LEAKING. WHEN THE SYRINGE WAS REMOVED AFTER INFLATION, THE ENTIRE PLASTIC SYRINGE PORT WAS NOTED TO COME OUT OF THE PILOT BALLOON LEADING TO INOPERABILITY OF THE CUFF AND SALINE LEAKING OUT. THE RESPIRATORY THERAPIST WAS THEN ABLE TO PUSH THE PLASTIC PORT BACK INTO THE PILOT BALLOON TO REINSERT INTO THE PATIENT. THERE WAS THEN SOME OBSERVED SALINE LEAKAGE UPON CUFF INFLATION. THERE WERE NO REPORTED ADVERSE PATIENT EFFECTS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10271809 ↗

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.