Bivona 75HA70Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 15021312013849), received between May 15, 2018 and Dec 29, 2025 — classified as 1 injury, 8 malfunctions.

The most frequently reported specific device problem is “Inflation Problem” (3 reports).

1 other recall cover devices cleared under the same FDA submission (K081440); 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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 29, 2025Deflation Problem; Deflation Problem

  IT WAS STATED THAT THE PATIENT WITH A TRACHEOSTOMY WAS CALLED TO THE DEPARTMENT TO PERFORM REST EFRS. THIS EXAMINATION REQUIRES REMOVING THE PATIENT¿S TRACHEOSTOMY CANNULA AND REPLACING IT WITH A LONG BALLOON CANNULA, IDENTICAL TO THOSE USED IN THE RESUSCITATION UNIT TO VENTILATE PATIENTS WITH A TRACHEOSTOMY. DURING THE EXAMINATION, WHICH TOOK PLACE WITHOUT DIFFICULTY, THE BALLOON WHICH HAD BEEN TESTED BEFORE THE INTRODUCTION OF THE CANNULA, COULD NOT BE DEFLATED, AND THE CANNULA COULD NOT BE REMOVED. GOOD TOLERANCE OF THE EPISODE: SENSATION OF DYSPNEA BUT SPO2 NORMAL AT 98 PERCENT, NO SIGN OF RESPIRATORY DISTRESS. THE PATIENT RECEIVED MEDICAL TREATMENT.

  Patient problems: Dyspnea

  MAUDE report 23919042 ↗
• MalfunctionSep 5, 2024Use of Incorrect Control/Treatment Settings; Use of Incorrect Control/Treatment Settings

  IT WAS REPORTED THAT THE INCIDENT OCCURRED WHEN CHANGING THE TRACHEOSTOMY TUBE. THE PATIENT'S CANNULA WAS INSERTED AFTER PERFORMING THE CUFF TEST ON THE DEVICE. AFTER A SHORT TIME IV VENTILATION COULD NO LONGER BE ENSURED. THIS WAS ACCOMPANIED BY A DROP IN SPO2. THE CUFF PRESSURE WAS NO LONGER MEASURABLE AND THE NURSING SERVICE HAD TO CALL THE EMERGENCY DOCTOR. THE PATIENT WAS ADMITTED TO THE HOSPITAL AS AN EMERGENCY. IN THE HOSPITAL, THE CANNULA WAS CHANGED AGAIN AND IT WAS NOTICED THAT IT WAS THE WRONG CANNULA. THERE WAS PATIENT INVOLVEMENT AND UNKNOWN PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20152720 ↗
• InjuryJun 11, 2024Inadequacy of Device Shape and/or Size; Failure to Deflate; Inadequacy of Device Shape and/or Size; Failure to Deflate

  IT WAS REPORTED THAT THE TRACHEOSTOMY TUBE WAS PLACED BUT WAS NOT LONG ENOUGH FOR THE PATIENT. THE DOCTOR HAD TO TRY TO ASPIRATE THE AIR OUT AND WAS NOT ABLE TO GET THE TRACH TUBE TO DEFLATE. ON SEVERAL ATTEMPTS IT FINALLY DEFLATED BUT THE PATIENT ENDED UP INTUBATED DURING THE TIME BEING DUE TO NOT BEING ABLE TO VENTILATE THE PATIENT. THE PATIENT HAS SIGNIFICANT TRACHEAL STENOSIS. THE DOCTOR FINALLY WAS ABLE TO REMOVE THE TRACH AND PLACE A NEW TRACH. THE PATIENT WAS RETURNED TO THE ICU ON THE VENTILATOR.

  Patient problems: Stenosis

  MAUDE report 19510147 ↗
• MalfunctionJun 10, 2024Separation Failure; Separation Failure

  IT WAS REPORTED THAT THE DEVICE WAS REMOVED FROM THE BOX AND READY TO BE USED, THE CUFF CANNOT BE REMOVED TOTALLY FROM THE CANNULA BODY. THE DEVICE WAS READY TO BE USED ON THE PATIENT, BUT IT WAS NOT POSSIBLE TO PROCEED. THERE WAS NO PATIENT INVOLVEMENT, NO HARM/ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19497966 ↗
• MalfunctionJan 4, 2023Device Damaged Prior to Use; Packaging Problem; Device Damaged Prior to Use; Packaging Problem

  IT WAS REPORTED THAT THERE WAS DEFORMATION ON THE CARTON AND INSIDE PACKING. 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 16096929 ↗
• MalfunctionApr 13, 2022Defective Device; Defective Device

  IT IS REPORTED THAT THE CUSTOMER HAS A TUBE THAT IS 1CM SHORTER THAN THE PREVIOUS ONE AND HAS CAUSED PATIENT DISCOMFORT. NO PATIENT INJURY

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14102946 ↗
• MalfunctionSep 10, 2018Inflation Problem; Inflation Problem

  IT WAS REPORTED THAT DURING A PRE-TEST CHECK, THE CUFF COMPONENT OF THE TRACHEOSTOMY TUBE FAILED TO INFLATE EQUALLY. NO DEATH OR SERIOUS INJURY WAS REPORTED IN CONNECTION WITH THIS INCIDENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7861776 ↗
• MalfunctionSep 10, 2018Inflation Problem; Inflation Problem

  IT WAS REPORTED THAT DURING A PRE-TEST CHECK, THE CUFF COMPONENT OF THE TRACHEOSTOMY TUBE FAILED TO INFLATE EQUALLY. NO DEATH OR SERIOUS INJURY WAS REPORTED IN CONNECTION WITH THIS INCIDENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7861774 ↗
• MalfunctionMay 15, 2018Inflation Problem; Inflation Problem

  USER FACILITY REPORTED THAT A TRACHEOSTOMY TUBE PARTIALLY INFLATED DURING THE PRE-CHECK TEST. NO MEDICAL INTERVENTION WAS REQUIRED AND NO PATIENT OR CLINICAL INJURY WAS ASSOCIATED WITH THIS OCCURRENCE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7515943 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K081440. One submission often covers many models, so check the product and lot details in each record.

• Z-2485-2020 · May 26, 2020 · Terminated
  Pediatric Adjustable Flange Tracheostomy Tube Cuffless