Bivona 67N035Recalls & reported problems

Summary

The FDA's MAUDE database contains 31 adverse event reports that list this exact device (DI 15021312006223), received between Oct 19, 2017 and May 14, 2024 — classified as 10 injuries, 21 malfunctions.

The most frequently reported specific device problem is “Inflation Problem” (24 reports).

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

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 18, 2026.

Recalls naming this device

1. May 29, 2024Class IOpen, 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-2606-2024 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 31 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 14, 2024Inflation Problem; Inflation Problem

  IT WAS REPORTED THAT THE CUFF ONLY INFLATED ON ONE SIDE. CUSTOMER TRIED TO KEEP THE CUFF INFLATED FOR AN HOUR WITH NO CHANGE. THE OTHER TUBE DID NOT INFLATE AT ALL. SECOND MALFUNCTION REPORTED UNDER PATIENT IDENTIFIER (B)(6) AND MFR REPORT NUMBER 9617604-2024-00437. THE SAMPLE WAS REPORTED AS NOT CONTAMINATED. THERE WAS PATIENT INVOLVEMENT. NO PATIENT INJURY NOR DEATH AND NO MEDICAL INTERVENTION REQUIRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19315313 ↗
• MalfunctionMay 14, 2024Inflation Problem; Inflation Problem

  IT WAS REPORTED THAT THE CUFF ONLY INFLATED ON ONE SIDE. CUSTOMER TRIED TO KEEP CUFF INFLATED FOR AN HOUR WITH NO CHANGE. THE OTHER TUBE DID NOT INFLATE AT ALL. THERE WAS PATIENT INVOLVEMENT AND NO HARM/ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19314749 ↗
• MalfunctionMay 9, 2024Fracture; Physical Resistance/Sticking; Fracture; Physical Resistance/Sticking

  IT WAS REPORTED THAT DURING A PATIENT'S TRACHEOSTOMY TUBE CHANGE BY THE ORL DOCTOR AND THE MEDICAL AND PARAMEDICAL TEAMS IN THE PEDIATRIC INTENSIVE CARE UNIT, DAMAGED AND NON-COMPLIANT CANNULAS (GLUED CUFF AND GLUED AND DAMAGED PLASTIC) WERE FOUND. THERE WAS PATIENT INVOLVEMENT, BUT THERE WERE NO CONSEQUENCES OF THE EVENT, ONLY THE RISK OF DETERIORATION OF THE PATIENT'S CONDITION (RISK OF INFECTIOUS HYGIENE OR RESPIRATORY INFECTION) IF THE DAMAGED CANNULA MAY HAVE BEEN USED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19280054 ↗
• MalfunctionMay 8, 2024Structural Problem; Structural Problem

  THE CUSTOMER REPORTED: " ON THE AFTERNOON OF 04-APR-2024, DURING A PATIENT'S TRACHEOSTOMY TUBE CHANGE BY THE ORL DOCTOR AND THE MEDICAL AND PARAMEDICAL TEAMS IN THE PEDIATRIC INTENSIVE CARE UNIT, DAMAGED AND NON-COMPLIANT CANNULAS (GLUED CUFF AND GLUED AND DAMAGED PLASTIC) WERE FOUND. AFTER OPENING 5 DIFFERENT BOXES, THEY FINALLY FOUND A USABLE CANNULA." THERE WAS PATIENT INVOLVEMENT, BUT THERE WERE NO CONSEQUENCES OF THE EVENT. THERE WAS RISK OF DETERIORATION OF THE PATIENT'S CONDITION (RISK OF INFECTIOUS HYGIENE OR RESPIRATORY INFECTION) IF THE DAMAGED CANNULA MAY HAVE BEEN USED. THE DEVICE IS NOT AVAILABLE FOR EVALUATION. THE NUMBER OF DEVICES INVOLVED FROM LOT 3904655 IS 2, BUT ONLY ONE IS AVAILABLE FOR INVESTIGATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19274503 ↗
• InjuryApr 3, 2024Disconnection; Inflation Problem; Disconnection; Inflation Problem

  IT WAS REPORTED THAT THE PATIENT HAD A DECANNULATED TRACH. THE TRACH WAS REPLACED WITH "EMERGENCY EQUIPMENT". A DECISION WAS MADE TO UPSIZE THE TRACH. A SECOND PRODUCT FAILURE OCCURRED FOR THE SAME PATIENT DURING THE EQUIPMENT CHECK OF THE UPSIZED PRODUCT. THAT MALFUNCTION WILL BE REPORTED UNDER EMDR-18428. A THIRD NEW TRACH HAD TO BE USED. THERE WAS NO NEGATIVE OUTCOME. ONLY A DELAY IN THE NEW TRACH INSERTION. "PATIENT HAD PATENT TRACH IN. THE CUFF DID NOT INFLATE FULLY CIRCUMFERENTIAL. CONCERN WAS THAT THE ATTEMPT TO INFLATE THE CUFF MAY HAVE BLOWN THE CUFF IN THE PROCESS."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19038077 ↗
• MalfunctionSep 6, 2023Inflation Problem; Inflation Problem

  IT WAS REPORTED THAT TWO DEVICES THAT WERE USED IN THE OPERATING ROOM WERE DEFECTIVE AND NOT INFLATING. PATIENT INVOLVEMENT UNKNOWN. THE SECOND INVOLVED DEVICE WAS DOCUMENTED ON COMPLAINT (B)(4).

  Patient problems: Insufficient Information

  MAUDE report 17691801 ↗
• MalfunctionAug 29, 2023Inflation Problem; Inflation Problem

  IT WAS REPORTED THAT THE CUFF OF THE TRACH TUBE WAS NOT INFLATING APPROPRIATELY. DESPITE MASSAGING OF BALLOON AND CUFF ITSELF, ONLY A PORTION OF IT WAS INFLATING. THIS WAS CHECKED PRIOR TO A SCHEDULED TRACH CHANGE; SO CAUGHT BEFOREHAND AND ANOTHER TUBE WAS USED. PATIENT THEREFORE UNAFFECTED AND NOT INVOLVED. PRODUCT IS RETURNING FOR INVESTIGATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17647580 ↗
• MalfunctionMay 11, 2023Inflation Problem; Inflation Problem

  IT WAS REPORTED THAT DURING THE PRE-TEST CUFF ASYMMETRY WAS FOUND. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16911491 ↗
• InjuryMay 3, 2023Inflation Problem; Physical Resistance/Sticking; Inflation Problem; Physical Resistance/Sticking

  IT WAS REPORTED THAT THE PATIENT HAS THREE TRACHS OF SAME ITEM AND LOT NUMBER. ONE TRACH WAS INSERTED INTO THE PATIENT AND THE PATIENT WAS DECOMPENSATING. THE TRACH WAS REMOVED AND FOUND TO BE STICKING AND NOT INFLATING SYMMETRICALLY. THE OTHER TWO TRACHS WERE TESTED OUTSIDE OF THE PATIENT AND THE SAME ISSUE WAS FOUND. ADDITIONAL INFORMATION REPORTED THAT A DIFFERENT BIVONA OF THE SAME SIZE WAS INSERTED INTO THE PATIENT AND THE PATIENT STABILIZED. THERE WERE NO REPORTS OF PATIENT HARM OR IMPACT ASSOCIATED WITH THE REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16861423 ↗
• InjuryMay 3, 2023Inflation Problem; Physical Resistance/Sticking; Inflation Problem; Physical Resistance/Sticking

  IT WAS REPORTED THAT THE PATIENT HAS THREE TRACHS OF SAME ITEM AND LOT NUMBER. ONE TRACH WAS INSERTED INTO THE PATIENT AND THE PATIENT WAS DECOMPENSATING. THE TRACH WAS REMOVED AND FOUND TO BE STICKING AND NOT INFLATING SYMMETRICALLY. THE OTHER TWO TRACHS WERE TESTED OUTSIDE OF THE PATIENT AND THE SAME ISSUE WAS FOUND. ADDITIONAL INFORMATION REPORTED THAT A DIFFERENT BIVONA OF THE SAME SIZE WAS INSERTED INTO THE PATIENT AND THE PATIENT STABILIZED. THERE WERE NO REPORTS OF PATIENT HARM OR IMPACT ASSOCIATED WITH THE REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16861331 ↗
• MalfunctionMar 2, 2023Inflation Problem; Leak/Splash; Inflation Problem; Leak/Splash

  IT WAS REPORTED THAT TWO CUFFS WERE NOT INFLATING AND ONE CUFF WAS LEAKING. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16475527 ↗
• MalfunctionMar 2, 2023Inflation Problem; Leak/Splash; Inflation Problem; Leak/Splash

  IT WAS REPORTED THAT TWO CUFFS WERE NOT INFLATING AND ONE CUFF WAS LEAKING. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16475517 ↗
• MalfunctionMar 2, 2023Inflation Problem; Leak/Splash; Naturally Worn; Inflation Problem; Leak/Splash; Naturally Worn

  IT WAS REPORTED THAT TWO CUFFS WERE NOT INFLATING AND ONE CUFF WAS LEAKING. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16475478 ↗
• MalfunctionDec 29, 2022Inflation Problem; Inflation Problem

  IT WAS REPORTED THAT THE CUFF WOULD NOT INFLATE. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16075408 ↗
• MalfunctionDec 29, 2022Inflation Problem; Inflation Problem

  IT WAS REPORTED THAT THE CUFF WOULD NOT INFLATE. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16075352 ↗
• InjuryOct 27, 2022Inflation Problem; Inflation Problem

  IT WAS REPORTED THAT A PEDIATRIC TRACHEOSTOMY WAS IN PLACE BUT THE BALLOON DID NOT PROPERLY INFLATE. THE PATIENT HAD SIGNIFICANT RESPIRATORY DISTRESS AND HIGH C02, DUE TO POOR VENTILATION. TO FIND A FUNCTIONING TRACHEOSTOMY BALLOON, 2 (TWO) OTHER TRACHEOSTOMIES WERE TESTED BUT REPORTEDLY FAILED. ADDITIONAL INFORMATION WAS RECEIVED VIA CUSTOMER EMAIL 20-OCT-2022: THE AWARENESS DATE WAS AMENDED.

  Patient problems: Decreased Respiratory Rate; Low Oxygen Saturation

  MAUDE report 15679970 ↗
• InjuryOct 27, 2022Inflation Problem; Inflation Problem

  IT WAS REPORTED THAT A PEDIATRIC TRACHEOSTOMY WAS IN PLACE BUT THE BALLOON DID NOT PROPERLY INFLATE. THE PATIENT HAD SIGNIFICANT RESPIRATORY DISTRESS AND HIGH C02, DUE TO POOR VENTILATION. TO FIND A FUNCTIONING TRACHEOSTOMY BALLOON, 2 (TWO) OTHER TRACHEOSTOMIES WERE TESTED BUT REPORTEDLY FAILED. ADDITIONAL INFORMATION WAS RECEIVED VIA CUSTOMER EMAIL 20-OCT-2022: THE AWARENESS DATE WAS AMENDED.

  Patient problems: Decreased Respiratory Rate; Low Oxygen Saturation

  MAUDE report 15679740 ↗
• InjuryOct 27, 2022Inflation Problem; Inflation Problem

  IT WAS REPORTED THAT A PEDIATRIC TRACHEOSTOMY WAS IN PLACE BUT THE BALLOON DID NOT PROPERLY INFLATE. THE PATIENT HAD SIGNIFICANT RESPIRATORY DISTRESS AND HIGH C02, DUE TO POOR VENTILATION. TO FIND A FUNCTIONING TRACHEOSTOMY BALLOON, 2 (TWO) OTHER TRACHEOSTOMIES WERE TESTED BUT REPORTEDLY FAILED. ADDITIONAL INFORMATION WAS RECEIVED VIA CUSTOMER EMAIL 20-OCT-2022: THE AWARENESS DATE WAS AMENDED.

  Patient problems: Decreased Respiratory Rate; Low Oxygen Saturation

  MAUDE report 15679595 ↗
• MalfunctionSep 20, 2022Inflation Problem; Inflation Problem

  IT WAS REPORTED THAT TWO TRACH CUFFS WERE NOT INFLATING PROPERLY. NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15460037 ↗
• MalfunctionApr 1, 2022Inflation Problem; Inflation Problem

  IT WAS REPORTED THAT DURING TRACH CARE WITH 2 NURSES, TRACH TUBE DISLODGED. IT WAS NOTICED THAT THE BALLOON ON THE TRACH STILL HAD 2 ML OF STERILE WATER (AS ORDERED) BUT THE INTERNAL PART WAS NOT INFLATING. THERE WAS NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13977265 ↗
• MalfunctionMar 17, 2022Inflation Problem; Inflation Problem

  IT WAS REPORTED WHILE PREPARING NEW TRACH AND EVALUATING THE PILOT BALLOON OF THE TRACH PRIOR TO INSERTION, IT WAS NOTICED THAT THE BALLOON WAS NOT CORRECTLY INFLATING. IT WAS NOTED THAT IT HAD DEFECTS TO THE PILOT BALLOON WHEN FILLING WITH WATER. THIS RESULTED IN A DELAY OF PLANNED CHANGE OF TRACH. THERE WAS NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13801733 ↗
• InjuryFeb 9, 2022Disconnection; Disconnection

  IT WAS REPORTED VIA USER FACILITY MEDWATCH 2200710000-2021-8028 THAT THE PATIENT'S TRACHEOSTOMY TUBE BECAME DISLODGED DURING ROUTINE CARE. THE TRACHEOSTOMY TUBE WAS REPLACED TO RESOLVE THE REPORTED EVENT.

  Patient problems: Airway Obstruction

  MAUDE report 13497663 ↗
• InjuryFeb 8, 2022Gas/Air Leak; Gas/Air Leak

  PER USER FACILITY MEDWATCH (B)(4). IT WAS REPORTED THAT A LARGE LEAK AROUND THE TRACH TUBE WAS NOTED IMMEDIATELY UPON INSERTION DESPITE THE CUFF BEING INFLATED WITH 2.5CC STERILE H2O. THE TRACH WAS EVENTUALLY ABLE TO BE SWAPPED WITH A WORKING TRACHEOSTOMY, RESOLVING THE EVENT.

  Patient problems: Airway Obstruction; No Clinical Signs, Symptoms or Conditions

  MAUDE report 13482392 ↗
• MalfunctionFeb 8, 2022Gas/Air Leak; Gas/Air Leak

  PER USER FACILITY MEDWATCH (B)(4). IT WAS REPORTED THAT A LARGE LEAK AROUND THE TRACH TUBE WAS NOTED IMMEDIATELY UPON INSERTION DESPITE THE CUFF BEING INFLATED WITH 2.5CC STERILE H2O. THE TRACH WAS EVENTUALLY ABLE TO BE SWAPPED WITH A WORKING TRACHEOSTOMY, RESOLVING THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13482234 ↗
• InjuryFeb 8, 2022Inflation Problem; Inflation Problem

  IT WAS REPORTED THAT THE TRACHEOSTOMY TUBE WAS INSERTED INTO THE PATIENT AND PATIENT WAS DECOMPENSATING. THE TUBE WAS REMOVED AND FOUND TO BE STICKING AND NOT INFLATING SYMMETRICALLY. A DIFFERENT TRACHEOSTOMY TUBE OF THE SAME SIZE WAS INSERTED INTO THE PATIENT AND THE PATIENT STABILIZED. THE PATIENT INJURY WAS RESOLVED.

  Patient problems: Unspecified Respiratory Problem

  MAUDE report 13481178 ↗