Bivona 850170Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 15021312006780), received between Dec 23, 2020 and Nov 11, 2025 — classified as 6 malfunctions.

The most frequently reported specific device problem is “Leak/Splash” (4 reports).

5 other recalls cover devices cleared under the same FDA submission (K083641, K913859); 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 16, 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.

• MalfunctionNov 11, 2025Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT THE TRACH TUBE EXHIBITED A LEAKAGE BETWEEN THE CANNULA AND FIXATION WINGS. WHEN INFLATED, THE CANNULA MAINTAINED THE PRESSURE OF THE CUFF; HOWEVER, WHEN THE BALLOON WAS OPENED, THE CUFF DEFLATED. THERE WAS PATIENT INVOLVEMENT, NO INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23522673 ↗
• MalfunctionSep 22, 2022Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED THAT THE PACKAGING WAS SEALED. WHEN OPENED, A HAIR WAS FOUND INSIDE THE CANNULA. NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15468974 ↗
• MalfunctionApr 1, 2021Flaked; Leak/Splash; Peeled/Delaminated; Flaked; Leak/Splash; Peeled/Delaminated

  INVESTIGATION COMPLETED AND SUMMARY IN H 10.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11606705 ↗
• MalfunctionApr 1, 2021Flaked; Leak/Splash; Material Integrity Problem; Flaked; Leak/Splash; Material Integrity Problem

  INVESTIGATION COMPLETED AND SUMMARY IN H 10.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11606695 ↗
• MalfunctionApr 1, 2021Flaked; Leak/Splash; Peeled/Delaminated; Flaked; Leak/Splash; Peeled/Delaminated

  INVESTIGATION COMPLETED AND SUMMARY IN H 10.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11606689 ↗
• MalfunctionDec 23, 2020Gas/Air Leak; Gas/Air Leak

  INFORMATION WAS RECEIVED INDICATING THAT A SMITHS MEDICAL TRACH WAS HEAD TO BE HISSING FROM THE CUFF WHILE IN A PATIENT. WHILE CLEANING, IT WAS NOTICED THAT THE VALVE ADAPTOR OF THE CUFF WAS CRACKED. THERE WERE NO REPORTED ADVERSE EVENTS.

  Patient problems: No Information

  MAUDE report 11067407 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K083641, K913859. One submission often covers many models, so check the product and lot details in each record.

• Z-0205-2024 · Aug 22, 2023 · Open, Classified
  Smiths Medical Portex Bivona Pediatric Tracheostomy Tube, Cuffless, Model 60P045, Sterile.
• Z-2946-2020 · Aug 28, 2020 · Terminated
  Bivona Mid-Range Aire-Cuf Adult Tracheostomy Tube This tube is intended to provide direct airway access for a tracheotomized patient for up to 29 days. It may be reprocessed up to
• Z-1465-2017 · Feb 9, 2017 · Terminated
  Bivona TTS (Tight to Shaft) Pediatric Tracheostomy Tube, Model No. 67SP035, Reorder No. 67SP035.
• Z-0339-2007 · Aug 31, 2006 · Terminated
  Bivona Adult Tracheostomy Tube, I.D. 8.5 mm, O.D 11.0 mm, Length 88 mm, TTS 11.8 mm, Mfrd by Smiths Medical Critical Care; Product code 670185.
• Z-0046-2007 · Aug 11, 2006 · Terminated
  Bivona Adult Tracheostomy Tube, Labeled I.D. 6.0 mm, O.D. 8.7 mm, A 7.0 mm, B 0 mm, C 53.0 mm, Mfrd by Smiths Medical Critical Care; REF 60A160.