Bivona XT18ES50NSC980NRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 15019517150650), received between Mar 17, 2020 and Apr 3, 2020 — classified as 2 injuries.

The most frequently reported specific device problem is “Fluid/Blood Leak” (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.

• InjuryApr 3, 2020Fluid/Blood Leak; Material Puncture/Hole; Fluid/Blood Leak; Material Puncture/Hole

  INFORMATION WAS RECEIVED INDICATING THAT THE CUFF TO A SMITHS MEDICAL PORTEX BIVONA FLEXTEND¿ TTS¿ TRACHEOSTOMY TUBE WAS FOUND LEAKING UPON ASSESSING THE PATIENT'S DROP-IN OXYGEN SATURATION LEVEL. THE CUFF WAS RE-INFLATED WITH 3MLS OF WATER AND WAS LATER CHECKED TO FIND ONLY 0.5MLS OF WATER LEFT. MOTHER STATED THAT THE ENT AND RESPIRATORY THERAPY WERE NOTIFIED WITH INSTRUCTION TO RE-INFLATE THE CUFF WITH WATER WHEN NEEDED UNTIL THE REPLACEMENT TRACH TUBE ARRIVED. THE TRACH TUBE WAS EVENTUALLY CHANGED OUT. IT WAS REPORTED THAT PART OF THE WEDGE USED TO REMOVE THE TUBE HAD CAUSED A MUCOUS PLUG WHICH WAS RELIEVED BY SUCTIONING. THE PATIENT'S MOTHER REPORTED AN ELEVATED HEART RATE AT THAT TIME BUT THEN RESOLVED. THERE WERE NO FURTHER REPORTED ADVERSE EFFECTS.

  Patient problems: Low Oxygen Saturation; Tachycardia

  MAUDE report 9925316 ↗
• InjuryMar 17, 2020Fluid/Blood Leak; Material Fragmentation; Fluid/Blood Leak; Material Fragmentation

  INFORMATION WAS RECEIVED INDICATING THAT THE CUFF TO A SMITHS MEDICAL PORTEX BIVONA FLEXTEND¿ TTS¿ TRACHEOSTOMY TUBE WAS FOUND LEAKING UPON ASSESSING THE PATIENT'S DROP-IN OXYGEN SATURATION LEVEL. THE CUFF WAS RE-INFLATED WITH 3MLS OF WATER AND WAS LATER CHECKED TO FIND ONLY 0.5MLS OF WATER LEFT. MOTHER STATED THAT THE ENT AND RESPIRATORY THERAPY WERE NOTIFIED WITH INSTRUCTION TO RE-INFLATE THE CUFF WITH WATER WHEN NEEDED UNTIL THE REPLACEMENT TRACH TUBE ARRIVED. THE TRACH TUBE WAS EVENTUALLY CHANGED OUT. IT WAS REPORTED THAT PART OF THE WEDGE USED TO REMOVE THE TUBE HAD CAUSED A MUCOUS PLUG WHICH WAS RELIEVED BY SUCTIONING. THE PATIENT'S MOTHER REPORTED AN ELEVATED HEART RATE AT THAT TIME BUT THEN RESOLVED. THERE WERE NO FURTHER REPORTED ADVERSE EFFECTS.

  Patient problems: Low Oxygen Saturation; Tachycardia

  MAUDE report 9845351 ↗

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.