Bivona 67SN030Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 15021312000245), received between Nov 5, 2020 and Mar 24, 2025 — classified as 9 malfunctions.

The most frequently reported specific device problem is “Inflation Problem” (4 reports).

1 FDA recall record name this device's identifier, 1 still open.

5 other recalls cover devices cleared under the same FDA submission (K083641, K914088); 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.

Recalls naming this device

1. May 29, 2024Open, Classified

   Smiths Medical has identified that the securement flange of specific lots of the Bivona Neonatal/Pediatric and Adult Tracheostomy products may tear because of a manufacturing defect.

   Z-2615-2024 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 24, 2025Inflation Problem; Inflation Problem

  IT WAS REPORTED THAT THE BALLOON DID NOT INFLATE. THE EVENT OCCURRED DURING TESTING. THERE WAS NO PATIENT INVOLVEMENT, AND NO PATIENT HARM/ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21678042 ↗
• MalfunctionAug 29, 2023Inflation Problem; Inflation Problem

  IT WAS REPORTED THAT DURING PRE-TESTING, THE BALLOON WAS NOT INFLATING. THE TUBE WAS BEING PREPARED FOR A NEWBORN BABY WHEN THE FAILURE WAS DISCOVERED. THE EVENT DID NOT AFFECT PATIENT CARE. NO INJURY OR ADVERSE EFFECTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17647611 ↗
• MalfunctionAug 29, 2023Inflation Problem; Inflation Problem

  IT WAS REPORTED THAT DURING PRE-TESTING THE BALLOON WOULD NOT INFLAT. NO ADVERSE PATIENT EFFECTS WERE REPORTED BY THE CUSTOMER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17646153 ↗
• MalfunctionJan 9, 2023Inflation Problem; Inflation Problem

  IT WAS REPORTED THE CUSTOMER OPENED A NEW 3.0 CUFFED TRACH FOR A ROUTINE TRACH CHANGE. TRACH CUFF WOULD NOT INFLATE FOR INSPECTION PRIOR TO USAGE. TRIED BOTH STERILE WATER AND AIR. NO PATIENT INJURY WAS REPORTED. ADDITIONAL INFORMATION RECEIVED ON (B)(6) 2022 VIA EMAIL AND ATTACHED TO COMPLAINT OBJECT: UNKNOWN LOT NUMBER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16122124 ↗
• MalfunctionSep 13, 2022Filling Problem; Filling Problem

  IT WAS REPORTED THAT THE DEVICE'S BALLOON INFLATED ASYMMETRICALLY. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15414996 ↗
• MalfunctionSep 13, 2022Volume Accuracy Problem; Volume Accuracy Problem

  IT WAS REPORTED THAT THE DEVICES BALLOON INFLATED ASYMMETRICALLY. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15414840 ↗
• MalfunctionNov 12, 2020Leak/Splash; Leak/Splash

  IT WAS REPORTED THE DEVICE WAS PLACED IN USE WITH PATIENT BUT DID NOT FULLY INFLATE ON BOTH SIDES OF THE CUFF. THE DEVICE WAS REMOVED AND REPLACED TO CONTINUE VENTILATION. NO FURTHER ADVERSE EFFECTS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10827259 ↗
• MalfunctionNov 6, 2020Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THE DEVICE WAS PLACED IN USE WITH PATIENT BUT DID NOT FULLY INFLATE ON BOTH SIDES OF THE CUFF. THE DEVICE WAS REMOVED AND REPLACED TO CONTINUE VENTILATION. NO FURTHER ADVERSE EFFECTS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10797728 ↗
• MalfunctionNov 5, 2020Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THE DEVICE WAS PLACED IN USE WITH PATIENT BUT DID NOT FULLY INFLATE ON BOTH SIDES OF THE CUFF. THE DEVICE WAS REMOVED AND REPLACED TO CONTINUE VENTILATION. NO FURTHER ADVERSE EFFECTS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10797422 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K083641, K914088. 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-0930-05 · Apr 26, 2005 · Terminated
  Bivona brand Pediatric TTS Tracheostomy Tube, 3.5 mm tracheostomy tubes with a 3.5mm obturator ; product code 67P035.
• Z-0302-06 · Feb 17, 2005 · Terminated
  Bivona brand Neonatal TTS Tracheostomy Tubes, sterile, product code 67N040.