Bivona 67P030Recalls & reported problems

Summary

The FDA's MAUDE database contains 16 adverse event reports that list this exact device (DI 15021312006254), received between Aug 7, 2018 and May 19, 2026 — classified as 9 injuries, 7 malfunctions.

The most frequently reported specific device problem is “Inflation Problem” (12 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 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-2610-2024 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 16 most recent of 16 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 19, 2026Break

  IT WAS REPORTED BY THE PATIENT THAT THE FLANGE WAS BROKEN ON THE TRACH AND FURTHER IT WAS REPLACED WITH A SAME SIZE TRACH BY THE CUSTOMER. THERE WAS PATIENT INVOLVEMENT AND NO HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25218778 ↗
• MalfunctionMay 11, 2023Physical Resistance/Sticking; Physical Resistance/Sticking

  IT WAS REPORTED THAT THE CUFF IS STICKING DURING PRE-TEST. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16910127 ↗
• MalfunctionMay 10, 2023Physical Resistance/Sticking; Physical Resistance/Sticking

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16905746 ↗
• InjuryMay 1, 2023Inflation Problem; Inflation Problem

  PATIENT RECEIVED NEW TRACH AT ABOUT 1800 AND SOME AGITATION AND BLOODY SUCTIONING OF THE TRACH WAS NOTED, THOUGH PATIENT WAS REPORTED TO BE ASLEEP AT SHIFT CHANGE. PATIENT WOKE UP AT 2100 AND WAS NOTED TO BE AGITATED WITH NO LEFT SIDED BREATH SOUNDS. UNTIL 2230 INCREASED WORK OF BREATHING, MOTTLED, BLUE, EMESIS AND STILL NO BREATH SOUNDS ON LEFT SIDE WAS REPORTED. MULTIPLE PROVIDERS CALLED TO BEDSIDE ON FOR INTERVENTIONS. INTERVENTIONS INCLUDED FI02 TO 100%, CPT, BAGGING, REPOSITION AND CHANGE OF TRACH TIES, X-RAY, TYLENOL, CONTINUED ASSESSMENT OF BREATH SOUNDS/VITALS/SUCTIONING (BRIGHT RED). PATIENT DID NOT IMPROVE AND SO A TRACH CHANGE WAS CARRIED OUT. ONCE REMOVED, IT WAS NOTED THAT THE CUFF WAS ONLY FILLING UP ON THE LEFT SIDE AND THEREFORE OCCLUDING OXYGENATION TO THE LEFT LUNG OF THE PATIENT.

  Patient problems: Decreased Respiratory Rate; Low Oxygen Saturation

  MAUDE report 16845896 ↗
• MalfunctionApr 30, 2023Inflation Problem; Inflation Problem

  IT WAS REPORTED THAT THE CUFF WAS NOT ABLE TO BE INFLATED. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16841392 ↗
• InjuryNov 4, 2022Inflation Problem; Nonstandard Device; Inflation Problem; Nonstandard Device

  IT WAS REPORTED THAT THE PATIENT ARRIVED TO UNIT WITH A CUFFLESS TRACHEOSTOMY TUBE. SIGNIFICANT LEAKAGE WAS OCCURRING WHILE ON THE VENTILATOR. PRIOR CHANGING THE PATIENT TO A CUFFED TUBE, THE BALLOON WAS ASSESSED FOR PROPER INFLATION. TWO CUFFED TRACHEOSTOMY TUBES INFLATED UNILATERALLY. EVENTUALLY, THE PATIENT'S TRACHEOSTOMY TUBE WAS UPSIZED; IT PROPERLY INFLATED. ADDITIONAL INFORMATION RECEIVED VIA CUSTOMER RESPONSE EMAIL 19-OCT-2022: THERE WERE 2 SEPARATE INCIDENTS / PATIENTS.

  Patient problems: Low Oxygen Saturation

  MAUDE report 15739347 ↗
• InjuryNov 4, 2022Inflation Problem; Nonstandard Device; Inflation Problem; Nonstandard Device

  IT WAS REPORTED THAT THE PATIENT ARRIVED TO UNIT WITH A CUFFLESS TRACHEOSTOMY TUBE. SIGNIFICANT LEAKAGE WAS OCCURRING WHILE ON THE VENTILATOR. PRIOR CHANGING THE PATIENT TO A CUFFED TUBE, THE BALLOON WAS ASSESSED FOR PROPER INFLATION. TWO CUFFED TRACHEOSTOMY TUBES INFLATED UNILATERALLY. EVENTUALLY, THE PATIENT'S TRACHEOSTOMY TUBE WAS UPSIZED; IT PROPERLY INFLATED. ADDITIONAL INFORMATION RECEIVED VIA CUSTOMER RESPONSE EMAIL 19-OCT-2022: THERE WERE 2 SEPARATE INCIDENTS / PATIENTS.

  Patient problems: Low Oxygen Saturation

  MAUDE report 15737216 ↗
• MalfunctionSep 26, 2022Defective Device; Defective Device

  IT WAS REPORTED THAT TWO CUFFS OF SAME ITEM AND LOT NUMBER HAD ISSUES, ONE INFLATED ASYMMETRICALLY AND THE OTHER WOULD NOT FILL AT ALL. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15487076 ↗
• MalfunctionApr 18, 2019Inflation Problem; Inflation Problem

  INFORMATION WAS RECEIVED THAT A SMITHS MEDICAL PORTEX BIVONA FLEXTEND TTS PEDIATRIC STRAIGHT NECK FLANGE TRACHEOSTOMY TUBE BALLOON WOULD NOT INFLATE SYMMETRICALLY. ISSUE WAS DISCOVERED WHILE IN USE WITH A PATIENT UNDER CARE OF HOME NURSING. IT WAS NOTED THE FAMILY DID NOT WANT TO "GIVE UP THIS TRACHEOSTOMY (TRACH) TUBE AS THEY HAVE NO OTHER TO USE AS REPLACEMENT". THERE WERE NO ADVERSE PATIENT EFFECTS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8527598 ↗
• InjuryApr 12, 2019Inflation Problem; Inflation Problem

  INFORMATION WAS RECEIVED THAT A SMITHS MEDICAL PORTEX BIVONA FLEXTEND TTS PEDIATRIC STRAIGHT NECK FLANGE TRACHEOSTOMY TUBE BALLOON WOULD NOT INFLATE SYMMETRICALLY. ISSUE WAS DISCOVERED WHILE IN USE WITH A PATIENT UNDER CARE OF HOME NURSING. SUBSEQUENTLY, THE NURSE WAS ABLE TO USE A "BACK- UP" TRACHEOSTOMY (TRACH) TUBE, AND NO PATIENT HARM OCCURRED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8511652 ↗
• InjuryApr 12, 2019Inflation Problem; Inflation Problem

  INFORMATION WAS RECEIVED THAT A SMITHS MEDICAL PORTEX BIVONA FLEXTEND TTS PEDIATRIC STRAIGHT NECK FLANGE TRACHEOSTOMY TUBE BALLOON WOULD NOT INFLATE SYMMETRICALLY. ISSUE WAS DISCOVERED WHILE IN USE WITH A PATIENT UNDER CARE OF HOME NURSING. SUBSEQUENTLY, THE NURSE WAS ABLE TO USE A "BACK- UP" TRACHEOSTOMY (TRACH) TUBE, AND NO PATIENT HARM OCCURRED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8511645 ↗
• InjuryMar 29, 2019Inflation Problem; Inflation Problem

  INFORMATION WAS RECEIVED THAT A SMITHS MEDICAL PORTEX BIVONA TTS CUFFED PEDIATRIC WITH V NECK FLANGE TRACHEOSTOMY TUBE CUFF BALLOON WOULD NOT INFLATE WHILE IN USE WITH A NICU PATIENT. SUBSEQUENTLY, A TRACHEOSTOMY CHANGE OUT WAS REQUIRED. THERE WERE NO ADVERSE PATIENT EFFECTS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8465787 ↗
• InjuryMar 29, 2019Inflation Problem; Inflation Problem

  INFORMATION WAS RECEIVED THAT A SMITHS MEDICAL PORTEX BIVONA TTS CUFFED PEDIATRIC WITH V NECK FLANGE TRACHEOSTOMY TUBE CUFF BALLOON WOULD NOT INFLATE WHILE IN USE WITH A NICU PATIENT. SUBSEQUENTLY, A TRACHEOSTOMY CHANGE OUT WAS REQUIRED. THERE WERE NO ADVERSE PATIENT EFFECTS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8465783 ↗
• InjuryMar 29, 2019Inflation Problem; Inflation Problem

  INFORMATION WAS RECEIVED THAT A SMITHS MEDICAL PORTEX BIVONA TTS CUFFED PEDIATRIC WITH V NECK FLANGE TRACHEOSTOMY TUBE CUFF BALLOON WOULD NOT INFLATE WHILE IN USE WITH A NICU PATIENT. SUBSEQUENTLY, A TRACHEOSTOMY CHANGE OUT WAS REQUIRED. THERE WERE NO ADVERSE PATIENT EFFECTS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8465780 ↗
• InjuryMar 29, 2019Inflation Problem; Inflation Problem

  INFORMATION WAS RECEIVED THAT A SMITHS MEDICAL PORTEX BIVONA TTS CUFFED PEDIATRIC WITH V NECK FLANGE TRACHEOSTOMY TUBE CUFF BALLOON WOULD NOT INFLATE WHILE IN USE WITH A NICU PATIENT. SUBSEQUENTLY, A TRACHEOSTOMY CHANGE OUT WAS REQUIRED. THERE WERE NO ADVERSE PATIENT EFFECTS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8465767 ↗
• MalfunctionAug 7, 2018Inflation Problem; Inflation Problem

  INFORMATION WAS RECEIVED INDICATING THAT THE BALLOON TO A SMITHS MEDICAL PORTEX® BIVONA® TTS¿ (TIGHT-TO-SHAFT) TRACHEOSTOMY TUBE WAS NOT INFLATING. TROUBLE SHOOTING METHODS WERE PERFORMED BY THE RESPIRATORY THERAPIST (RT) WITH NO SUCCESS. THERE WERE NO REPORTED ADVERSE EFFECTS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7759110 ↗