Bivona 60A160Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 15021312005554), received between Apr 10, 2017 and Mar 23, 2026 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 23, 2026Material Puncture/Hole; Tear, Rip or Hole in Device Packaging

  IT WAS REPORTED THAT THE TRACH TUBE EXHIBITED A HOLE IN THE DEVICE. THERE WAS PATIENT INVOLVEMENT, NO INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24669760 ↗
• MalfunctionDec 3, 2024Inflation Problem; Inflation Problem

  IT WAS REPORTED THAT THE CUFF WAS DEFECTIVE AND DID NOT COMPLETELY ENCIRCLE THE TUBE/STUCK TO ONE SIDE OF THE TUBE. THE ISSUE WAS DISCOVERED PRIOR TO PATIENT USE. THE EVENT OCCURRED DURING TESTING OF THE CUFF. THERE WAS NO HARM/ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20833680 ↗
• MalfunctionJun 8, 2017Connection Problem; Connection Problem

  IT WAS REPORTED THAT THE OUTER DIAMETER OF A PORTEX® BIVONA® UNCUFFED ADULT TRACHEOSTOMY TUBE WAS TOO WIDE TO ALLOW FOR ATTACHMENT TO THE VENTILATOR. THE TRACHEOSTOMY TUBE HAD BEEN INSERTED INTO THE STOMA OF THE PATIENT FOR A WEEKLY TRACHEOSTOMY TUBE CHANGE. AFTER INSERTION, THE RESPIRATORY THERAPIST ATTEMPTED TO RECONNECT THE VENTILATOR TO THE TRACHEOSTOMY TUBE, WHICH IS WHEN IT WAS DISCOVERED THE OUTER DIAMETER OF THE TRACHEOSTOMY TUBE TO CONNECT TO THE VENTILATOR. THE RESPIRATORY THERAPIST REMOVED THE TRACHEOSTOMY TUBE AND INSERTED ANOTHER TUBE OF THE SAME SIZE AND ATTACHED IT TO THE VENTILATOR. NO INJURY WAS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6622485 ↗
• MalfunctionApr 10, 2017Device Dislodged or Dislocated; Material Integrity Problem; Device Dislodged or Dislocated; Material Integrity Problem

  IT WAS REPORTED THAT A PORTEX® BIVONA® UNCUFFED ADULT TRACHEOSTOMY TUBE FLANGES RIPPED OPEN, WHICH CAUSED THE TUBE TO BE DISLODGED AT THE SITE WHERE THE TRACHEOSTOMY TUBE TIES WERE THREADED THROUGH. THE PATIENT WAS USING POSEY TRACHEOSTOMY TUBE TIES WHEN THE EVENT OCCURRED. IT WAS NOTED THAT THE PATIENT DID NOT HAVE A HISTORY OF PULLING THE TUBE OR MANIPULATING THE TUBE TIES, AND THE TIES WERE NOT TIED TIGHTER THAN RECOMMENDED. THE DEVICE WAS USED FOR UP TO ONE MONTH PRIOR TO BEING SANITIZED VIA LIGHT RINSING AND BOILING WATER UP TO TWO TIMES BEFORE THE FAILURE OCCURRED. THE TUBE WAS REPLACED WITH A NEW TUBE. NO PATIENT INJURY WAS REPORTED. SEE MFR: 3012307300-2017-00829.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6477384 ↗
• MalfunctionApr 10, 2017Device Dislodged or Dislocated; Material Integrity Problem; Device Dislodged or Dislocated; Material Integrity Problem

  IT WAS REPORTED THAT A PORTEX® BIVONA® UNCUFFED ADULT TRACHEOSTOMY TUBE FLANGES RIPPED OPEN, WHICH CAUSED THE TUBE TO BE DISLODGED AT THE SITE WHERE THE TRACHEOSTOMY TUBE TIES WERE THREADED THROUGH. THE PATIENT WAS USING POSEY TRACHEOSTOMY TUBE TIES WHEN THE EVENT OCCURRED. IT WAS NOTED THAT THE PATIENT DID NOT HAVE A HISTORY OF PULLING THE TUBE OR MANIPULATING THE TUBE TIES, AND THE TIES WERE NOT TIED TIGHTER THAN RECOMMENDED. THE DEVICE WAS USED FOR UP TO ONE MONTH PRIOR TO BEING SANITIZED VIA LIGHT RINSING AND BOILING WATER UP TO TWO TIMES BEFORE THE FAILURE OCCURRED. THE TUBE WAS REPLACED WITH A NEW TUBE. NO PATIENT INJURY WAS REPORTED. SEE MFR: 3012307300-2017-00828.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6477378 ↗

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.