Bivona 67PFSS40Recalls & reported problems

Summary

The FDA's MAUDE database contains 115 adverse event reports that list this exact device (DI 10351688518699), received between Nov 28, 2017 and Nov 3, 2025 — classified as 30 injuries, 85 malfunctions.

The most frequently reported specific device problem is “Inflation Problem” (45 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. 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-2614-2024 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 115 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 3, 2025Material Puncture/Hole; Gas/Air Leak; Material Puncture/Hole; Gas/Air Leak

  IT WAS REPORTED THAT THE CUFF WAS NOT FULLY DEFLATED, ONLY ONE SIDE WAS INFLATED, AND THE PATIENT WAS HARMED DUE TO AIR LEAKAGE AROUND THE TRACHEA. REPORTER STATED THE OUTCOME WAS STILL ONGOING, AND INDICATED DAMAGE WAS OBSERVED ON THE CUFF AND RESULTING IN THE LEAKAGE. ANY ADVERSE EVENTS OF THE PEDIATRIC PATIENT AS A RESULT OF THE AIR LEAKAGE WERE NOT INDICATED BY THE CUSTOMER.

  Patient problems: Insufficient Information

  MAUDE report 23457630 ↗
• MalfunctionOct 30, 2025Break; Break

  IT WAS REPORTED THAT THE TRACH BROKE OR WAS SPLIT WHILE IN USE AT THE PATIENT'S HOME. PER REPORTER, MEDICAL INTERVENTION WAS REQUIRED. REPORTER ALLEGED THAT THE ISSUE HAPPENED CONSTANTLY AND THEY HAVE TO WAIT FOR THE FOLLOWING MONTH TO RECEIVE A REPLACEMENT DEVICE. REPORTER ALLEGED THAT THEY ARE DEALING WITH HIGH MVI ALARMS ON THE PATIENT'S VENTILATOR AND LACK OF FULL OXYGEN SUPPLY DUE TO THIS ISSUE.

  Patient problems: Low Oxygen Saturation

  MAUDE report 23426635 ↗
• MalfunctionOct 30, 2025Gas/Air Leak; Gas/Air Leak

  IT WAS REPORTED THAT THE TRACH CUFF DID NOT STAY INFLATED. PER REPORTER, AIR WAS PUT INTO THE CUFF BUT AFTER A FEW MINUTES IT WAS COMPLETELY DEFLATED. IT IS UNCLEAR IF THE PRODUCT WAS FAILING INSTRUCTIONS-FOR-USE TESTING. THERE WAS UNKNOWN PATIENT INVOLVEMENT. NO PATIENT HARM/ADVERSE EVENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23425788 ↗
• MalfunctionAug 20, 2025Inflation Problem; Inflation Problem

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22853543 ↗
• MalfunctionJun 25, 2025Material Deformation; Material Deformation

  IT WAS REPORTED THAT BEFORE THEY EXCHANGE THE TRACH, SHE PLACED THE CUFF ON WATER AND NOTICED THAT THE TRACH INFLATION WAS ASYMMETRICAL ON THE SIDES. CUFF ONLY INFLATED ON ONE SIDE, EVEN AFTER DOING MULTIPLE ATTEMPTS TO DEFLATE AND RE-INFLATE TO RESOLVE IT. ISSUE WAS ONLY RESOLVED AFTER A NEW TRACH TUBE WAS OBTAINED AND PLACED. THERE WAS PATIENT INVOLVEMENT, HOWEVER NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22331308 ↗
• MalfunctionApr 4, 2025Inflation Problem; Inflation Problem

  ADDITIONAL INFORMATION WAS RECEIVED THAT THE PRODUCT FAULT OCCURRENCE WAS WHEN THEY TOOK IT OUT FROM THE BOX. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21777061 ↗
• MalfunctionMar 21, 2025Inflation Problem; Inflation Problem

  IT WAS REPORTED THAT THE CUFF DID NOT SEEM TO INFLATE. THERE WAS NO MEDICAL INTERVENTION REQUIRED AS A RESULT OF THE EVENT. NO PATIENT HARM WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21670641 ↗
• InjuryMar 20, 2025Inflation Problem; Inflation Problem

  IT WAS REPORTED THAT THE CUFF DID NOT INFLATE WHILE IN USE WITH THE PATIENT. TO RESOLVE THE ISSUE, THE CUSTOMER REPLACED THE TRACH. THE CUSTOMER REPORTED PATIENT INJURY DUE TO THE EVENT BUT PROVIDED NO FURTHER DETAILS. MORE INFORMATION WAS REQUESTED AND IF RECEIVED, WILL BE SENT IN A FOLLOW UP REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21657339 ↗
• InjuryMar 19, 2025Inflation Problem; Inflation Problem

  IT WAS REPORTED THAT THE CUFF DID NOT INFLATE. THE ISSUE WAS RESOLVED BY USING A DIFFERENT TRACH. PATIENT INJURY WAS REPORTED AS A RESULT OF THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21648638 ↗
• MalfunctionFeb 4, 2025Inflation Problem; Inflation Problem

  IT WAS REPORTED THAT THE CUFF WAS NOT INFLATING. THERE WAS UNKNOWN PATIENT INVOLVEMENT AND UNKNOWN PATIENT HARM/ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21307116 ↗
• InjuryJan 3, 2025Inflation Problem; Inflation Problem

  IT WAS REPORTED THAT THE CUFF DID NOT INFLATE. THE EVENT HAPPENED AT THE HOSPITAL AND WAS OPERATED BY A HEALTH PROFESSIONAL. THE ISSUE WAS RESOLVED BY USING A DIFFERENT TRACH. THERE WAS PATIENT INVOLVEMENT, AND PATIENT INJURY WAS REPORTED, BUT NO ADDITIONAL DETAILS WERE GIVEN.

  Patient problems: Insufficient Information

  MAUDE report 21068407 ↗
• InjuryDec 3, 2024Gas/Air Leak; Gas/Air Leak

  CORRECTION: THERE WAS PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20832216 ↗
• MalfunctionOct 21, 2024Failure to Deliver; Failure to Deliver

  IT WAS REPORTED THAT THE SMALL BALLOON DID NOT WORK. THERE WAS UNKNOWN PATIENT INVOLVEMENT, AND NO PATIENT HARM/ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20494867 ↗
• MalfunctionSep 10, 2024Burst Container or Vessel; Burst Container or Vessel

  IT WAS REPORTED THAT BOTH DEVICES BLEW UP WHEN THEY PUT WATER INSIDE. THERE WAS UNKNOWN PATIENT INVOLVEMENT, AND NO PATIENT HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20183430 ↗
• MalfunctionJan 4, 2024Inflation Problem; Defective Component; Inflation Problem; Defective Component

  IT WAS REPORTED THAT THE DEVICE WAS "DEFECTIVE AND IS NOT CUFFING". PATIENT INVOLVEMENT IS UNKNOWN.

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

  MAUDE report 18447563 ↗
• MalfunctionNov 15, 2023Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT THE PATIENT HAS RECEIVED A DEFECTIVE TRACH. THE DEVICE WAS CRACKED, CAUSING IT TO LEAK. IT IS A LEAKAGE IN THE NEW TRACH. WHEN THE CUSTOMER ADDS "FIVE ML INSIDE THE WATER CUFF IT WILL NOT BLOW UP AT ALL". ADVERSE EFFECTS ARE UNKNOWN.

  Patient problems: Insufficient Information

  MAUDE report 18143703 ↗
• MalfunctionOct 30, 2023Gas/Air Leak; Gas/Air Leak

  IT WAS REPORTED THAT THE CUSTOMER HAD A FEW LEAKY CUFF ISSUES WHICH INITIALLY THEY THOUGHT OF AS, BUT WERE OCCURRING MORE FREQUENTLY. THIS HAS BEEN REPORTED WITH TRACH SIZES 4.0 (2 V-FLANGED PEDS PATIENTS; 1 PED FLEXTEND). PATIENTS WERE VENTILATED, STAFF NOTICED AN INCREASE IN CUFF LEAK ON THE VENT AND AUDIBLY. WHEN CUFF VOLUME CHECKED, THERE WAS AN ML LOSS. SOMETIMES IT WAS UNDER 0.5 ML, SOMETIMES OVER. WHEN THE TRACHS HAVE BEEN CHECKED FOR LEAKS, THE CUSTOMER COULD NOT DETECT ANY LEAK FROM THE CUFF ITSELF OR THE PILOT BALLOON OR AT THE BALLOON INSERTION LINE. CUSTOMER HAVE HAD 2 4.0 V FLANGE PEDIATRIC CUFFED BIVONA WITH THIS ISSUE. PREVIOUSLY, THERE WAS A CONCERN WITH A FLEXTEND BIVONA 4.0. THERE WAS NO PATIENT HARM BUT NEEDED TO CHANGE THE TRACH TUBE EARLIER TO TROUBLESHOOT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18031516 ↗
• MalfunctionSep 15, 2023Inflation Problem; Inflation Problem

  IT WAS REPORTED THAT A PATIENT WAS DECOMPENSATING AND NEEDED A TRACH EXCHANGE. A NEW TRACH TUBE WAS OPENED. PRE-TESTING INFLATION OF THE CUFF WAS COMPLETED TO ENSURE IT WAS NOT COMPROMISED. THE CUFF, HOWEVER, ONLY INFLATED ON ONE SIDE. ANOTHER TRACH PACKAGE WAS OPENED. SUBSEQUENT CHECK ASCERTAINED EFFECTIVENESS OF NEW TRACH. ADVERSE EFFECTS HAVE NOT BEEN REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 17761383 ↗
• MalfunctionJul 10, 2023Insufficient Device Problem Information; Insufficient Device Problem Information

  THE EVENTS OF THIS COMPLAINT IS UNKNOWN. PATIENT INVOLVEMENT UNKNOWN.

  Patient problems: Insufficient Information

  MAUDE report 17289922 ↗
• MalfunctionJun 22, 2023Defective Component; Defective Component

  IT WAS REPORTED THAT DURING PRE-TESTING THE DEVICE WAS FOUND TO HAVE A DEFECTIVE CUFF.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17186776 ↗
• MalfunctionJun 22, 2023Defective Component; Defective Component

  IT WAS REPORTED THAT THE DEVICE HAD A "DEFECTIVE CUFF". 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 17186701 ↗
• MalfunctionJun 22, 2023Defective Component; Defective Component

  IT WAS REPORTED THAT THE DEVICE HAD A "DEFECTIVE CUFF". 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 17186571 ↗
• MalfunctionJun 14, 2023Defective Device; Defective Device

  IT WAS REPORTED, THAT A TRACH CHANGE WAS DONE. NO PATIENT HARM REPORTED.

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

  MAUDE report 17131257 ↗
• MalfunctionApr 12, 2023Inflation Problem; Inflation Problem

  IT WAS REPORTED THAT WHEN TRYING TO FILL THE BALLOON THE PILOT BALLOON FILLS WITH WATER BUT DOES NOT FILL CUFF. THEY DID PUT IN THE PATIENT AND THEN REALIZED THAT THE BALLOON DID NOT INFLATE. THERE HAS BEEN NO REPORT OF PATIENT INJURY OR NO OBSERVABLE CLINICAL SYMPTOMS OR A CHANGE IN SYMPTOMS IDENTIFIED IN THE PATIENT.

  Patient problems: Insufficient Information

  MAUDE report 16722288 ↗
• MalfunctionApr 7, 2023Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT THE CUFF DOES NOT INFLATE. IT LEAKS OUT INTO THE BALLOON ON 2 DIFFERENT LOT NUMBERS. THERE WAS NO ADVERSE EVENT OR SERIOUS INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16701060 ↗

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.