Bivona 67PFSS45Recalls & reported problems

Summary

The FDA's MAUDE database contains 61 adverse event reports that list this exact device (DI 10351688518705), received between Mar 20, 2017 and Mar 31, 2026 — classified as 10 injuries, 51 malfunctions.

The most frequently reported specific device problem is “Inflation Problem” (29 reports).

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

1 other recall cover devices cleared under the same FDA submission (K923878); 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. How this data works · Data updated Oct 13, 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-2614-2024 · Root cause: Under Investigation by firm · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 61 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 31, 2026Gas/Air Leak

  IT WAS REPORTED THE TUBE WAS CHANGED DUE TO A LEAK. UPON INSPECTION OF THE REMOVED TUBE CUFF, IT WAS NOT INFLATING SYMMETRICALLY. THERE WAS UNKNOWN PATIENT INVOLVEMENT AND UNKNOWN PATIENT HARM/ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24746105 ↗
• MalfunctionFeb 3, 2026Deflation Problem

  IT WAS REPORTED THAT THE TUBE WAS INSITU AND WOULD NOT DEFLATE DURING A ROUTINE CHANGE. THE OTHER TUBE IN THE CHILD'S EMERGENCY BOX WAS CHECKED, AND IT WOULD NOT INFLATE DESPITE BEING CHECKED DAILY. TRACHEOSTOMY TUBES WITH THIS LOT NUMBER WERE REMOVED FROM PATIENT'S HOME AND REPLACED, CCN STORES CHECKED AND LOT NUMBERS REMOVED IF SAME AS THE INCIDENT. IT IS THE SECOND TIME THIS HAS HAPPENED. THERE WAS PATIENT INVOLVEMENT. THE DURATION OF IMPLANTATION WAS 6 MONTHS. THE OPERATOR OF THE DEVICE WAS THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24247815 ↗
• MalfunctionJan 23, 2026Inflation Problem

  IT WAS REPORTED THAT THE CUFF WAS DAMAGED AND NOT INFLATING DURING TRACH CHANGE. THERE WAS NO PATIENT HARM/ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24161546 ↗
• MalfunctionOct 23, 2025Fluid/Blood Leak; Material Puncture/Hole; Fluid/Blood Leak; Material Puncture/Hole

  IT WAS REPORTED THAT THE TUBING WAS TORN FROM THE INFLATION PORT, CAUSING WATER TO LEAK. PER REPORTER, THE NURSE NOTICED THE VENTILATOR STATING THE PATIENT HAD A LEAK AND NOTICED THAT THE CUFF ON THE PATIENT'S TRACHEOSTOMY WAS DEFLATED. PER REPORTER, THE NURSE THEN TRIED TO INFLATE IT WITH 3MLS OF WATER AND THE WATER LEAKED OUT OF THE TUBING. THE TRACHEOSTOMY WAS CHANGED, AND THE ISSUE WAS RESOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23375259 ↗
• MalfunctionOct 21, 2025Inflation Problem; Inflation Problem

  IT WAS REPORTED THAT ONLY HALF INFLATED. THE EVENT OCCURRED DURING TESTING AT HOME, ONLY 1 SIDE INFLATES LEAVING PARTIAL AIRWAY. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23348071 ↗
• MalfunctionOct 15, 2025Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT THE TRACH TUBE EXHIBITED A LEAKAGE. THERE WAS PATIENT INVOLVEMENT, UNKNOWN IF THERE WAS PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23280466 ↗
• MalfunctionAug 13, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT WHEN DEFLATING THE TRACHEOSTOMY CUFF, THE VALVE FROM THE BALLOON BECAME DISCONNECTED AND WAS ATTACHED TO THE SYRINGE. THE TUBE WAS REMOVED. PATIENT INVOLVEMENT WAS UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22793854 ↗
• MalfunctionJul 22, 2025Pressure Problem; Material Split, Cut or Torn; Pressure Problem; Material Split, Cut or Torn

  IT WAS REPORTED THAT THE SPLIT WAS NOTICED IN THE SILICONE. THERE WAS UNKNOWN PATIENT INVOLVEMENT, AND IT WAS REPORTED THERE WAS NO SIGNS OR SYMPTOMS EXPERIENCED. THE TUBE WAS CHANGED AS A MEDICAL INTERVENTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22565621 ↗
• MalfunctionJun 2, 2025Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT PARENT REPORTED A BREAK IN THE SILICONE SHEATH OF THE TRACHEOSTOMY TUBE. PARENT REMOVED AND REPLACED THE TRACHEOSTOMY AS SOON AS NOTICED. THERE WAS PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22126240 ↗
• MalfunctionApr 4, 2025Break; Break

  IT WAS REPORTED THAT THE PLASTIC SHAFT WAS BROKEN. IT IS NOTED THAT THIS ISSUE COULD CAUSE A DELAY IN TREATMENT, POTENTIALLY IMPACTING THE PATIENT'S RECOVERY TIME. THE WAS NO KNOWN PATIENT HARM OR ADVERSE EVENTS REPORTED AS A RESULT OF THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21777790 ↗
• MalfunctionFeb 7, 2025Inflation Problem; Inflation Problem

  IT WAS REPORTED THAT THE CUFF WAS DAMAGED AND NOT INFLATING. EVENT OCCURRED DURING TRACH CHANGE. EVENT OCCURRED AT THE HOSPITAL IN UAE. OPERATOR OF THE DEVICE WAS AN RT. THERE WAS NO PATIENT HARM/ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21333506 ↗
• MalfunctionFeb 3, 2025Inflation Problem; Inflation Problem

  IT WAS REPORTED THAT THE BALLOON DID NOT INFLATE CORRECTLY. THE EVENT WAS ON (B)(6) 2025 WHEN IT WAS OPENED. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21298278 ↗
• MalfunctionJan 20, 2025Inflation Problem; Inflation Problem

  IT WAS REPORTED THAT THE TRACH BALLOON DID NOT INFLATE PROPERLY. IT IS UNKNOWN IF THE DEVICE IS AVAILABLE FOR INVESTIGATION. THE REPORTED PRODUCT FAULT OCCURRED WHEN PARENTS WENT TO BLOW UP BALLOON IN THE TRACH. THEY HAD TO USE THEIR SPARE TRACH. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21193209 ↗
• MalfunctionJan 20, 2025Inflation Problem; Inflation Problem

  IT WAS REPORTED THAT THE TRACH BALLOON DID NOT INFLATE PROPERLY. IT IS UNKNOWN IF THE DEVICE IS AVAILABLE FOR INVESTIGATION. THE REPORTED PRODUCT FAULT OCCURRED WHEN PARENTS WENT TO BLOW UP BALLOON IN THE TRACH. THEY HAD TO USE THEIR SPARE TRACH. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21193156 ↗
• MalfunctionDec 31, 2024Gas/Air Leak; Gas/Air Leak

  IT WAS REPORTED THAT THE PRODUCT WAS LEAKING WHEN THE CUFF WAS IN INFLATED OR DEFLATED STATE. NO PATIENT HARM HAS BEEN REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21048755 ↗
• MalfunctionJul 19, 2024Inflation Problem; Inflation Problem

  IT WAS REPORTED THAT THE BALLOON WOULD NOT INFLATE OUT OF THE BOX. THERE WAS NO PATIENT INVOLVEMENT AND NO PATIENT HARM/ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19784182 ↗
• InjuryJun 5, 2024Difficult to Remove; Difficult to Remove

  IT WAS REPORTED THAT THE "FLEXIBLE SILICONE SHEATH ON METAL OBTURATOR CAME OVER TIP CAUSING THE OBTURATOR TO BECOME STUCK IN TRACH DURING REMOVAL". MEDICAL INTERVENTION REQUIRED DUE TO DEFECTIVE DEVICE REMOVED IMMEDIATELY AND ROUTINE TRACH CHANGE CHANGED INTO AN EMERGENT ONE. PATENT AIRWAY ESTABLISHED WITH NEW TRACH. NO ADVERSE PATIENT EFFECTS WERE REPORTED BY THE CUSTOMER. THE PROBLEM OCCURRED TWICE. IT WAS UNKNOWN IF THE SAME PRODUCT WAS USED BOTH TIMES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19467996 ↗
• MalfunctionMar 18, 2024Inflation Problem; Inflation Problem

  IT WAS REPORTED THAT A CALL WAS RECEIVED A CUSTOMER STATING THAT THE TRACH'S BALLOON WOULD NOT BLOW UP IN THE THROAT. IT KEPT GETTING "STUCK". THERE WAS PATIENT INVOLVEMENT WITH UNKNOWN PATIENT HARM/ADVERSE EVENT REPORTED. THE CUSTOMER WOULD PUT WATER IN IT, IT WAS DETACHING. ADDITIONAL INFORMATION WAS REQUESTED; HOWEVER, NO FURTHER SPECIFIC DETAILS ON THIS INCIDENT WERE RECEIVED.

  Patient problems: Insufficient Information

  MAUDE report 18925041 ↗
• MalfunctionMar 18, 2024Inflation Problem; Inflation Problem

  IT WAS REPORTED THAT A CALL WAS RECEIVED A CUSTOMER STATING THAT THE TRACH'S BALLOON WOULD NOT BLOW UP IN THE THROAT. IT KEPT GETTING "STUCK". THERE WAS PATIENT INVOLVEMENT WITH UNKNOWN PATIENT HARM/ADVERSE EVENT REPORTED. THE CUSTOMER WOULD PUT WATER IN IT, IT WAS DETACHING. ADDITIONAL INFORMATION WAS REQUESTED; HOWEVER, NO FURTHER SPECIFIC DETAILS ON THIS INCIDENT WERE RECEIVED.

  Patient problems: Insufficient Information

  MAUDE report 18924705 ↗
• MalfunctionFeb 5, 2024Device Dislodged or Dislocated; Gas/Air Leak; Device Dislodged or Dislocated; Gas/Air Leak

  IT WAS REPORTED THAT THE TUBE WAS LEAKING AND NOT STAYING IN PLACE. PATIENT INVOLVEMENT UNKNOWN.

  Patient problems: Insufficient Information

  MAUDE report 18646383 ↗
• MalfunctionJun 22, 2023Inflation Problem; Inflation Problem

  IT WAS REPORTED, THAT THE CUFF ON A 4.5MM TRACHEOSTOMY TUBE WAS "FAULTY". AND WOULD NOT INFLATE. THEREFORE, IT COULD NOT BE USED. NO PATIENT INJURY OR CLINICAL AFFECTS WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17186997 ↗
• MalfunctionMay 2, 2023Inflation Problem; Inflation Problem

  IT WAS REPORTED THAT THE CUFF WAS NOT INFLATING DURING PRE-TEST. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16852422 ↗
• MalfunctionMar 24, 2023Inflation Problem; Inflation Problem

  IT WAS REPORTED THAT UPON OPENING WHEN THE THERAPIST ATTEMPTED TO INFLATE THE PILOT BALLOON DURING A PRE-USE CHECK THE BALLOON WAS NOT INFLATING. NO PATIENT INJURY OR CLINICAL AFFECTS WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16612860 ↗
• MalfunctionMar 2, 2023Inflation Problem; Inflation Problem

  IT WAS REPORTED THAT THE DEVICE CUFF NOT INFLATING DURING PRE-TEST. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16475579 ↗
• MalfunctionNov 4, 2022Inflation Problem; Inflation Problem

  IT WAS REPORTED THAT AFTER 2 TIMES RE-PREPARATION OF THE TRACH, THE CUFF ONLY FILLS UP TO ONE SIDE. NO INJURY REPORTED. ADDITIONAL INFORMATION RECEIVED VIA E-MAIL 14-OCT-2022: PATIENT LOCATION UPDATED. THE PRODUCT IS NOT RETURNING FOR INVESTIGATION DUE TO THE INFORMATION THAT GERMS WERE DETECTED WITH THE PATIENT, GERMS WHICH HAVE MULTI-RESISTANCE CHARACTERISTICS. THEREFORE, THE PHOTOS IN THE ATTACHMENTS SHOULD BE USED INSTEAD. ADDITIONAL INFORMATION RECEIVED VIA E-MAIL 04-NOV-2022: LOT NUMBER REMAINS UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15733864 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K923878. One submission often covers many models, so check the product and lot details in each record.

• Z-0260-2007 · Nov 17, 2006 · Terminated
  Custom 5.5 mm Bivona Uncuffed Hyperflex Tracheostomy Tube, I.D. 5.5 mm, O.D. 8.0 mm, length 4.75 mm, Mfrd by Smiths Medical Critical Care; REF HU05JS55NNA112S.