Bivona 60A170Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 15021312005561), received between Nov 29, 2023 and Nov 12, 2024 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Fitting Problem” (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 18, 2026.

Most reported problems

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 12, 2024Fitting Problem; Fitting Problem

  IT WAS REPORTED, THAT DURING SET-UP, THE OPENING WAS TOO SMALL. SO, IT WAS NOT POSSIBLE TO CONNECT THE SPEAKING VALVE TO THE OPENING OF THE TRACHEOSTOMY CANNULA. IN OTHER WORDS, THE SPEAKING VALVE WAS LOOSE AND DIDN¿T FIT PROPERLY. THERE WAS NO PATIENT INVOLVEMENT. AND NO HUMAN HARM. THE EVENT OCCURRED, WHEN IT WAS TIME FOR THE PATIENT TO CHANGE THE CANNULA. THE PRODUCT WAS UNPACKED AND AFTER THE CHANGE, THE SPEECH VALVE WAS LOOSE AND FELL AT THE SLIGHTEST MOVEMENT. AFTER THE INCIDENT, A NEW PRODUCT WAS UNPACKED AND IT WORKED PERFECTLY. THE SPEECH VALVE SAT VERY WELL. THIS REPORT IS TO DOCUMENT THE EVENT NOTED, ON EMDR-43663, REPORT REFERENCE NUMBER (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20667491 ↗
• MalfunctionNov 12, 2024Fitting Problem; Fitting Problem

  IT WAS REPORTED THAT DURING SET-UP THE OPENING WAS TOO SMALL, SO IT WAS NOT POSSIBLE TO CONNECT THE SPEAKING VALVE TO THE OPENING OF THE TRACHEOSTOMY CANNULA. IN OTHER WORDS, THE SPEAKING VALVE WAS LOOSE AND DIDN¿T FIT PROPERLY. THERE WAS NO PATIENT INVOLVEMENT AND NO HUMAN HARM. THE EVENT OCCURRED WHEN IT WAS TIME FOR THE PATIENT TO CHANGE THE CANNULA, THE PRODUCT WAS UNPACKED AND AFTER THE CHANGE, THE SPEECH VALVE WAS LOOSE AND FELL AT THE SLIGHTEST MOVEMENT. AFTER THE INCIDENT, A NEW PRODUCT WAS UNPACKED, AND IT WORKED PERFECTLY. THE SPEECH VALVE SAT VERY WELL. THE PATIENT WAS ABLE TO GO HOME. THE REPORTER STATED THAT EXACTLY THE SAME PROBLEM HAPPENED ON A PREVIOUS OCCASION WITH THE SAME PATIENT, THE PROBLEM WAS SOLVED IN THE SAME WAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20666216 ↗
• MalfunctionJun 19, 2024Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  IT WAS REPORTED THAT THE ISO-15 CONNECTOR IS TOO SMALL. SPEAKING VALVES ARE NOT FIXED WHEN AN INNER CANNULA IS USED. THERE WAS NO PATIENT INVOLVEMENT AND NO HUMAN HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19566342 ↗
• MalfunctionJun 18, 2024Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  IT WAS REPORTED THAT THE ISO-15 CONNECTOR IS TOO SMALL. SPEAKING VALVES ARE NOT FIXED WHEN AN INNER CANNULA IS USED. THERE WAS NO PATIENT INVOLVEMENT AND NO HUMAN HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19563743 ↗
• MalfunctionNov 29, 2023Device Markings/Labelling Problem; Missing Information; Device Markings/Labelling Problem; Missing Information

  IT WAS REPORTED THAT THE INCLUDED INSTRUCTIONS FOR USE (IFU) IS INCOMPLETE. THE DANISH TRANSLATION WAS MISSING. ADDITIONALLY THE TRANSLATION OF THE PRODUCT NAME CONTAINED A TYPO ON THE LABEL. LABEL REPORTED TO HAVE READ "SILICONETRAKEOSTOMITUDE". CORRECT IS "SILICONETRAKEOSTOMITUBE". PHOTOS SHOW UNOPENED PRODUCT BOXES. NO PATIENT INVOLVEMENT OR ADVERSE EFFECTS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18234396 ↗

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.