Bivona ST19EN55NGG996NRecalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 15019517190663), received between Aug 14, 2019 and Sep 17, 2021 — classified as 6 injuries.

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

• InjurySep 17, 2021Mechanical Problem; Detachment of Device or Device Component; Mechanical Problem; Detachment of Device or Device Component

  INFORMATION WAS RECEIVED INDICATING THAT WHILE IN USE OF A SMITHS MEDICAL TRACHEOSTOMY/SILICONE - BIVONA TUBES CUSTOM, THE TRACH KEPT COMING FALLING OUT. IT WAS ALSO REPORTED THAT THE PATIENT WAS TRYING TO REINSERT THE INFLATION LINE AFTER IT HAD COME OUT. TO REINSERT THE INFLATION LINE, THE PATIENT WAS USING THEIR TEETH TO STABILIZE THE PILOT BALLOON AND ENDED UP BITING THROUGH THE PILOT BALLOON. SUBSEQUENTLY, TRACH CHANGE OUT WAS PERFORMED. NO FURTHER ADVERSE EFFECTS WERE REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 12490671 ↗
• InjurySep 17, 2020Leak/Splash; Leak/Splash

  INFORMATION WAS RECEIVED INDICATING THAT LEAKING OCCURRED FOUR DAYS FOLLOWING PLACEMENT OF A SMITHS MEDICAL PORTEX BIVONA CUSTOM TRACHEOSTOMY TUBE. IT WAS REPORTED THAT THE PATIENT REQUIRES THAT THE CUFF BE INFLATED WITH SLEEP FOR PROPER VENTILATION. SO, A TRACH TUBE CHANGE OUT WAS PERFORMED. THERE WERE NO REPORTED ADVERSE PATIENT EFFECTS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10545828 ↗
• InjurySep 17, 2020Leak/Splash; Leak/Splash

  INFORMATION WAS RECEIVED INDICATING THAT LEAKING OCCURRED SIX DAYS FOLLOWING PLACEMENT OF A SMITHS MEDICAL PORTEX BIVONA CUSTOM TRACHEOSTOMY TUBE. IT WAS REPORTED THAT THE PATIENT REQUIRES THAT THE CUFF BE INFLATED WITH SLEEP FOR PROPER VENTILATION. SO, A TRACH TUBE CHANGE OUT WAS PERFORMED. THERE WERE NO REPORTED ADVERSE PATIENT EFFECTS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10545793 ↗
• InjuryOct 8, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  INFORMATION WAS RECEIVED THAT THE STOPPER ON THE PILOT BALLOON OF A SMITHS MEDICAL TRACHEOSTOMY POPS OUT. NO ADVERSE EFFECTS REPORTED.

  Patient problems: Extubate; No Information

  MAUDE report 9168551 ↗
• InjuryAug 14, 2019Material Separation; Material Separation

  INFORMATION WAS RECEIVED INDICATING THAT 24 HOURS FOLLOWING PLACEMENT OF A SMITHS MEDICAL PORTEX® BIVONA CUSTOMIZED TRACHEOSTOMY (TRACH) TUBE THE PORT IS LEFT OPEN TO THE CUFF FOLLOWING FILLING. IT WAS REPORTED THAT WHEN THE SYRINGE IS REMOVED AFTER FILLING THE CUFF, THE INSIDE WHITE PLASTIC PIECE COMES OUT, LEAVING AN OPENING INTO THE PATIENT'S CUFF. SUBSEQUENTLY, THE TUBE WAS CHANGED OUT WITH NO ADVERSE PATIENT EFFECTS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8894634 ↗
• InjuryAug 14, 2019Leak/Splash; Leak/Splash

  INFORMATION WAS RECEIVED INDICATING THAT FOLLOWING 24 HOURS AFTER PLACEMENT OF A SMITHS MEDICAL PORTEX® BIVONA CUSTOMIZED TRACHEOSTOMY (TRACH) TUBE THE CUFF WAS NOT HOLDING WATER. THE LINE THAT ATTACHES TO THE CUFF WAS REPORTED TO BE LEAKING. SUBSEQUENTLY, A TRACH TUBE CHANGE OUT WAS PERFORMED. THERE WERE NO REPORTED ADVERSE PATIENT EFFECTS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8894307 ↗

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.