Bivona 850190Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 15021312006803), received between Feb 8, 2019 and Nov 30, 2022 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Material Split, Cut or Torn” (2 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 30, 2022Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT UPON RECEIPT OF ITEM, IT WAS FOUND THAT THE PROTECTIVE LAYER OVER YELLOW FOAM WAS TORN. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15885786 ↗
• MalfunctionSep 19, 2022Material Puncture/Hole; Material Puncture/Hole

  IT WAS REPORTED THAT THE CUSTOMER NOTED HOLES IN THE CUFF. NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15446388 ↗
• MalfunctionSep 14, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE TUBE THAT CONNECTS THE CUFF TO THE EXTERNAL VALVE (RED) DETACHED. THERE HAS BEEN NO REPORT OF PATIENT INVOLVEMENT OR NO OBSERVABLE CLINICAL SYMPTOMS OR A CHANGE IN SYMPTOMS IDENTIFIED IN THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15420918 ↗
• MalfunctionFeb 8, 2019Break; Material Split, Cut or Torn; Break; Material Split, Cut or Torn

  INFORMATION WAS RECEIVED INDICATING THAT THE CANNULA TO A SMITHS MEDICAL PORTEX® BIVONA® ADULT FOME-CUF® TRACHEOSTOMY TUBE BROKE. THE HOSE FOR THE CUFF WAS ALSO REPORTED TO BE TORN OFF. IT WAS REPORTED THAT IMPROPER USE OR PULLING ON THE HOSE WAS EXCLUDED AS FAULT. DE-BLOCKING OF THE CANNULA WAS PERFORMED BY USING AN INJECTION NEEDLE AND A SYRINGE. THERE WERE NO REPORTED ADVERSE PATIENT EFFECTS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8323708 ↗

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.