Bivona 67SP045Recalls & reported problems

Summary

The FDA's MAUDE database contains 47 adverse event reports that list this exact device (DI 15021312000733), received between Oct 25, 2019 and Oct 15, 2025 — classified as 19 injuries, 28 malfunctions.

The most frequently reported specific device problem is “Inflation Problem” (22 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 25 most recent of 47 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 15, 2025Inflation Problem; Inflation Problem

  IT WAS REPORTED THAT THE CUFF WAS NOT INFLATING EVENLY. THE EVENT OCCURRED DURING PRE-TEST AT THE HOSPITAL. THE OPERATOR OF THE DEVICE WAS A HEALTH PROFESSIONAL. THEY DID NOT USE THE DEFECTIVE PRODUCT AND OPENED A NEW ONE WITH NO ISSUE. THIS IS AN OUT OF BOX FAILURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23289786 ↗
• MalfunctionMay 12, 2025Inflation Problem; Inflation Problem

  IT WAS REPORTED THAT THE CUFF DID NOT INFLATE EVENLY. THERE WERE NO PATIENT HARM OR ADVERSE EVENTS REPORTED AS A RESULT OF THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22002622 ↗
• MalfunctionMar 6, 2025Inflation Problem; Inflation Problem

  IT WAS REPORTED THAT THE CUFF DID NOT INFLATE EVENLY. THERE WERE NO PATIENT HARM OR ADVERSE EVENTS REPORTED AS A RESULT OF THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21532933 ↗
• MalfunctionFeb 20, 2025Inflation Problem; Inflation Problem

  IT WAS REPORTED THAT DURING PRETESTING OF THE TRACH TUBE THE RESPIRATORY THERAPISTS INDICATED THAT THE TUBE ONLY INFLATED ON ONE SIDE DESPITE MULTIPLE ATTEMPTS TO INFLATE IT UNIFORMLY. THERE WAS NO MEDICAL INTERVENTION REQUIRED. THERE WERE NO INJURIES OR ADVERSE EVENTS REPORTED AS A RESULT OF THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21428452 ↗
• MalfunctionJan 14, 2025Inflation Problem; Inflation Problem

  IT WAS REPORTED THAT DURING A TRACH CHANGE, THE CUFF WOULD NOT INFLATE. THERE WAS UNKNOWN PATIENT INVOLVEMENT AND UNKNOWN PATIENT HARM/ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21150372 ↗
• MalfunctionJul 11, 2023Stretched; Stretched

  IT WAS REPORTED THAT PRIOR TO USE, THE CUFF WAS TESTED AND FOUND TO BE NOT SYMMETRICAL. CUSTOMER STATES THIS COULD CAUSE PRESSURE TO THE TRACHEA. THE DEVICE WAS NOT USED ON THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17303251 ↗
• MalfunctionJul 11, 2023Stretched; Stretched

  IT WAS REPORTED THAT PRIOR TO USE, THE CUFF WAS TESTED AND FOUND TO BE NOT SYMMETRICAL. CUSTOMER STATES THIS COULD CAUSE PRESSURE TO THE TRACHEA. THE DEVICE WAS NOT USED ON THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17303247 ↗
• MalfunctionNov 7, 2022Nonstandard Device; Nonstandard Device

  IT WAS REPORTED THAT THE CUFF WAS CHECKED BEFORE USE, BUT IT WAS NOT SYMMETRICAL CAUSING PRESSURE ON THE PATIENT'S TRACHEA. ADDITIONAL INFORMATION WAS RECEIVED VIA CUSTOMER RESPONSE EMAIL 19-OCT-2022: ALL TUBES WERE CHECKED PRIOR TO PATIENT USE. NO MEDICAL INTERVENTION WAS REQUIRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15742205 ↗
• MalfunctionNov 4, 2022Nonstandard Device; Nonstandard Device

  IT WAS REPORTED THAT THE CUFF WAS CHECKED BEFORE USE, BUT IT WAS NOT SYMMETRICAL CAUSING PRESSURE ON THE PATIENT'S TRACHEA. ADDITIONAL INFORMATION WAS RECEIVED VIA CUSTOMER RESPONSE EMAIL 19-OCT-2022: ALL TUBES WERE CHECKED PRIOR TO PATIENT USE. NO MEDICAL INTERVENTION WAS REQUIRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15736439 ↗
• MalfunctionNov 4, 2022Nonstandard Device; Nonstandard Device

  IT WAS REPORTED THAT THE CUFF WAS CHECKED BEFORE PATIENT USE, IT WAS NOT SYMMETRICAL, AND APPLIED PRESSURE TO THE PATIENTS TRACHEA. NO MEDICAL INTERVENTION WAS REQUIRED. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15735777 ↗
• MalfunctionSep 26, 2022Failure to Unfold or Unwrap; Failure to Unfold or Unwrap

  IT WAS REPORTED THE DEVICE HAD A DEFECTIVE BALLOON. NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15486233 ↗
• MalfunctionSep 22, 2022Defective Device; Defective Device

  IT WAS REPORTED THAT THE FOUR CUFFS WERE NOT INFLATING SYMMETRICALLY WITH HALF THE CUFF STICKING TO THE TUBE. NO PATIENT INJURY WAS REPORTED

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15466893 ↗
• MalfunctionSep 19, 2022Inflation Problem; Inflation Problem

  IT WAS REPORTED THAT THE CUFF NOT EVENLY INFLATING. CUFF IS STICKING TO THE PLASTIC MOLDED CONTAINER. NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15446493 ↗
• MalfunctionSep 15, 2022Volume Accuracy Problem; Volume Accuracy Problem

  IT WAS REPORTED THAT THE DEVICE WAS STICKING TO ONE SIDE OF THE TUBE AND WOULD INFLATE ASYMMETRICALLY. THE ISSUE WAS RESOLVED WHEN ATTEMPTED AGAIN BUT WAS NOT USE ON PATIENT DUE TO THE MALFUNCTION. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15433482 ↗
• MalfunctionSep 14, 2022Deflation Problem; Deflation Problem

  IT WAS REPORTED THAT DURING PRE-TEST, THE CUFF INFLATED ASYMMETRICALLY. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15417500 ↗
• MalfunctionSep 14, 2022Inflation Problem; Inflation Problem

  IT WAS REPORTED THAT DURING PRE-TEST, THE CUFF INFLATED ASYMMETRICALLY. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15417468 ↗
• MalfunctionSep 14, 2022Inflation Problem; Inflation Problem

  IT WAS REPORTED THAT DURING PRE-TEST, THE CUFF INFLATED ASYMMETRICALLY. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15417429 ↗
• MalfunctionSep 14, 2022Inflation Problem; Inflation Problem

  IT WAS REPORTED THAT THE DEVICE WAS NOT INFLATING SYMMETRICALLY. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15417428 ↗
• MalfunctionSep 14, 2022Inflation Problem; Inflation Problem

  IT WAS REPORTED THAT THE DEVICE WAS NOT INFLATING SYMMETRICALLY. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15417379 ↗
• MalfunctionSep 14, 2022Inflation Problem; Inflation Problem

  IT WAS REPORTED THAT THE DEVICE WAS NOT INFLATING SYMMETRICALLY. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15417378 ↗
• MalfunctionSep 13, 2022Inflation Problem; Inflation Problem

  IT WAS REPORTED THAT FOUR CUFFS WERE NOT INFLATING SYMMETRICALLY WITH HALF THE CUFF STICKING TO THE TUBE. NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15414825 ↗
• MalfunctionSep 13, 2022Inflation Problem; Inflation Problem

  IT WAS REPORTED THAT FOUR CUFFS WERE NOT INFLATING SYMMETRICALLY WITH HALF THE CUFF STICKING TO THE TUBE. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15414809 ↗
• MalfunctionSep 13, 2022Inflation Problem; Inflation Problem

  IT WAS REPORTED THAT FOUR CUFFS WERE NOT INFLATING SYMMETRICALLY WITH HALF THE CUFF STICKING TO THE TUBE. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15414804 ↗
• MalfunctionSep 13, 2022Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT DURING PRE-TESTING OF A NEW DEVICE, IT WAS FOUND THAT IT WAS NOT INFLATING FULLY DESPITE MANIPULATIONS. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15410647 ↗
• MalfunctionOct 30, 2021Inflation Problem; Inflation Problem

  CUSTOMER REPORTS AN ISSUE WITH THE CUFF WHICH DOES NOT INFLATE EVENLY.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 12725073 ↗

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.