Bivona 67HA80Recalls & reported problems

Summary

The FDA's MAUDE database contains 24 adverse event reports that list this exact device (DI 15021312013818), received between Oct 12, 2017 and Sep 25, 2026 — classified as 9 injuries, 15 malfunctions.

The most frequently reported specific device problem is “Leak/Splash” (9 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 18, 2026.

Most reported problems

Recent adverse event reports

The 24 most recent of 24 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 25, 2026Gas/Air Leak

  It was stated that the tracheostomy tube was placed and found leakage. There was a patient involvement and there was unknown patient harm.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50897193 ↗
• MalfunctionSep 25, 2026Gas/Air Leak

  It was stated that the tracheostomy tube was placed and found leakage. There was a patient involvement and there was unknown patient harm.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50897171 ↗
• MalfunctionMar 17, 2026Gas/Air Leak

  IT WAS REPORTED THAT THERE WAS A CUFF LEAKAGE FOUND ON THE DAY OF USE. THE EVENT OCCURRED WHILE IN USE WITH PATIENT AT THE HOSPITAL. THERE WAS NO MEDICAL INTERVENTION REQUIRED. THE EVENT WAS RESOLVED BY REPLACING WITH A NEW ONE. THERE WAS A PATIENT INVOLVEMENT BUT THERE WAS NO PATIENT HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24621150 ↗
• MalfunctionAug 25, 2025Gas/Air Leak; Gas/Air Leak

  IT WAS REPORTED THAT LEAKAGE WAS FOUND AFTER ONE (1) DAY OF USE. THIS PROBLEM WAS RESOLVED BY REPLACING WITH A NEW ONE, AND THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22890585 ↗
• MalfunctionApr 4, 2025Inflation Problem; Inflation Problem

  IT WAS REPORTED THAT AFTER 5 HOURS SET UP, THE RESIDUAL AMOUNT OF WATER IN THE CUFF WAS 1ML. AFTER 3 HOURS UPON REPLACING THE DEVICE, THE RESIDUAL AMOUNT OF WATER IN THE CUFF WAS 1ML. THERE WAS NO MEDICAL INTERVENTION REQUIRED. THERE WAS UNKNOWN PATIENT HARM OR ADVERSE EVENTS REPORTED AS A RESULT OF THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21780405 ↗
• MalfunctionMar 11, 2025Loose or Intermittent Connection; Loose or Intermittent Connection

  IT WAS REPORTED THAT THE SECOND DAY OF THE PATIENT'S TREATMENT, THE LOCKING PIN CAME LOOSE FROM THE TUBE. A NEW TRACHEOSTOMY TUBE WAS USED TO FIX THE ISSUE. THE INCIDENT OCCURRED WHILE THE PATIENT WAS BEING TREATED. THE EVENT OCCURRED IN THE HOSPITAL AND WAS OPERATED BY HEALTH PROFESSIONAL. THERE WAS PATIENT INVOLVEMENT, AND NO PATIENT HARM/ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21573145 ↗
• MalfunctionJan 30, 2025Gas/Air Leak; Gas/Air Leak

  IT WAS STATED THAT THE CUFF LEAKAGE WAS FOUND AFTER TEN DAYS WHILE IN USE WITH A PATIENT. THE EVENT OCCURRED WHILE IN USE WITH PATIENT. THE DATE OF EVENT WAS ON (B)(6) 2025. THE OPERATOR OF DEVICE WAS A HEALTH PROFESSIONAL. THE EVENT OCCURRED IN HOSPITAL. THERE WAS NO REPORT OF ADVERSE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21276740 ↗
• MalfunctionSep 4, 2024Gas/Air Leak; Gas/Air Leak

  IT WAS REPORTED THAT THERE WAS A CUFF LEAK ON THE TRACHEOSTOMY TUBES. THIS ISSUE WAS SOLVED BY REPLACING WITH A NEW BIVONA (B)(6), WITH DIFFERENT LOT NUMBER. THERE WAS NO PATIENT INVOLVEMENT AND NO PATIENT HARM/ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20140162 ↗
• InjuryDec 19, 2023Gas/Air Leak; Gas/Air Leak

  IT WAS REPORTED THAT THE CUFF LEAKED AFTER 14 DAYS OF USE AND WAS RESOLVED BY REPLACING WITH A NEW KIT. NO PATIENT INJURY OR CLINICAL AFFECTS WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18359985 ↗
• MalfunctionNov 30, 2023Labelling, Instructions for Use or Training Problem; Device Markings/Labelling Problem; Missing Information; Labelling, Instructions for Use or Training Problem; Device Markings/Labelling Problem; Missing Information

  IT WAS REPORTED THAT "DURING A SUBMISSION OF A TENDER IN DENMARK, THE INCLUDED INSTRUCTIONS FOR USE (IFU) WAS INCOMPLETE AND THE DANISH TRANSLATION WAS MISSING. ADDITIONALLY THE TRANSLATION OF THE PRODUCT NAME CONTAINED A TYPO ON THE LABEL (READS SILICONE TRAKEOSTOMI TUBE, CORRECT IS SILICONE TRAKEOSTOMI TUBE)".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18241963 ↗
• MalfunctionAug 29, 2023Inflation Problem; Inflation Problem

  IT WAS REPORTED THAT DURING PRE-TESTING THE PILOT BALLOON INFLATED BUT THE CUFF HARDLY INFLATED OR SLOWLY INFLATED. NO ADVERSE PATIENT EFFECTS WERE REPORTED BY THE CUSTOMER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17646199 ↗
• MalfunctionMay 11, 2023Component Missing; Component Missing

  IT WAS REPORTED THAT A TRACH WAS FOUND WITHOUT THE LOCKING PIN AND HAD THE WRONG LOCKING TAB LOCATION. NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16916794 ↗
• MalfunctionApr 6, 2023Component Missing; Incomplete or Missing Packaging; Component Missing; Incomplete or Missing Packaging

  IT WAS REPORTED THAT A NEW TRACHEOSTOMY WAS FOUND WITHOUT LOCKING PIN AND WRONG LOCKING TAB LOCATION. NO INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16694011 ↗
• MalfunctionOct 13, 2022Device Markings/Labelling Problem; Device Markings/Labelling Problem

  IT WAS REPORTED THAT UPON OPENING THE PRODUCT, THE NURSE READ THE PRODUCT INSTRUCTION FOR USE (IFU) AND COMPARED THE ENGLISH TEXT TO THE FINNISH TEXT AND NOTICED THAT THE TRANSLATION WAS NOT CORRECT, OBSERVED WITH FOUR LOT NUMBERS. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15598848 ↗
• MalfunctionApr 28, 2022Break; Leak/Splash; Break; Leak/Splash

  IT WAS REPORTED THAT THE JUNCTION OF PILOT BALLOON WAS FOUND BROKEN AND CAUSED LEAKAGE DURING PRE-TEST. NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14239701 ↗
• InjuryFeb 5, 2020Leak/Splash; Leak/Splash

  INFORMATION WAS RECEIVED INDICATING THAT THE CUFF TO A SMITHS MEDICAL PORTEX® BIVONA® ADULT TTS¿ ADJUSTABLE NECK FLANGE HYPERFLEX¿ TRACHEOSTOMY TUBE WAS REPORTED TO BE BROKEN AND LEAKING 20 HOURS FOLLOWING PLACEMENT. A TRACH TUBE CHANGE OUT WAS PERFORMED WITH NO REPORTED ADVERSE EFFECTS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9673916 ↗
• InjuryNov 11, 2019Leak/Splash; Material Puncture/Hole; Scratched Material; Leak/Splash; Material Puncture/Hole; Scratched Material

  INFORMATION WAS RECEIVED INDICATING THAT 3 DAYS FOLLOWING PLACEMENT OF A SMITHS MEDICAL BIVONA® ADULT TTS¿ HYPERFLEX¿ TRACHEOSTOMY TUBE THE VENTILATOR WAS ALARMING AND 3MLS OF WATER WAS REMAINING IN THE CUFF. IT WAS REPORTED THAT INITIALLY 8MLS OF STERILE WATER WAS USED TO INFLATE THE CUFF. THE PHYSICIAN HAD DECIDED TO USE THIS TYPE OF TRACH AS THE PATIENT HAD A TRACHEOMALACIA. SUBSEQUENTLY, A TRACH TUBE CHANGE OUT WAS PERFORMED. A PINHOLE ON THE CUFF WAS FOUND FOLLOWING REMOVAL. THERE WERE NO REPORTED ADVERSE PATIENT EFFECTS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9306192 ↗
• InjuryNov 11, 2019Leak/Splash; Material Puncture/Hole; Scratched Material; Leak/Splash; Material Puncture/Hole; Scratched Material

  INFORMATION WAS RECEIVED INDICATING THAT 10 DAYS FOLLOWING PLACEMENT OF A SMITHS MEDICAL BIVONA® ADULT TTS¿ HYPERFLEX¿ TRACHEOSTOMY TUBE THE VENTILATOR WAS ALARMING AND 3MLS OF WATER WAS REMAINING IN THE CUFF. IT WAS REPORTED THAT INITIALLY 8MLS OF STERILE WATER WAS USED TO INFLATE THE CUFF. THE PHYSICIAN HAD DECIDED TO USE THIS TYPE OF TRACH AS THE PATIENT HAD A TRACHEOMALACIA. SUBSEQUENTLY, A TRACH TUBE CHANGE OUT WAS PERFORMED. A PINHOLE ON THE CUFF WAS FOUND FOLLOWING REMOVAL. THERE WERE NO REPORTED ADVERSE PATIENT EFFECTS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9306144 ↗
• InjuryMay 9, 2019Leak/Splash; Leak/Splash

  INFORMATION WAS RECEIVED THAT A SMITHS MEDICAL TRACHEOSTOMY WAS UNABLE TO CONNECT TO VENTILATOR AT SITE BETWEEN 15MM CONNECTOR AND TUBE. THIS RESULTED IN AN AIR LEAK, A VENTILATOR ALARM AND A TRACHEOSTOMY TUBE CHANGE OUT FOR THE PATIENT. NO INJURY TO THE PATIENT OCCURRED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8596570 ↗
• InjuryAug 22, 2018Leak/Splash; Material Perforation; Leak/Splash; Material Perforation

  INFORMATION WAS RECEIVED INDICATING THAT THREE DAYS FOLLOWING INSERTION OF A SMITHS MEDICAL PORTEX® BIVONA® ADULT TTS¿ HYPERFLEX¿ TRACHEOSTOMY TUBE A CUFF LEAK WAS NOTED. THE PATIENT'S FAMILY NOTED THAT THERE WAS NO AIR LEAK PRESENT UPON TRACHEOSTOMY (TRACH) TUBE CHANGE OUT. THE FAMILY ALSO SPECULATED THAT THE CUFF MEMBRANE MAY HAVE BECOME THINNER OR THAT THE MATERIAL HAS CHANGED. THE TUBE WAS REQUIRED TO BE CHANGED OUT WITH NO REPORTED ADVERSE EFFECTS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7806001 ↗
• MalfunctionJul 24, 2018Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT BIVONA® ADULT TTS¿ ADJUSTABLE NECK FLANGE HYPERFLEX¿ TRACHEOSTOMY TUBE HAD A CUFF LEAK AFTER 5 DAYS OF USE. THE PATIENT WAS PANTING AS A RESULT OF THIS INCIDENT. THE PATIENT CHANGED OUT THE TRACH TUBE, AND WAS REPORTED TO BE IN STABLE CONDITION AFTER THIS. NO FURTHER COMPLICATION WERE REPORTED.

  Patient problems: Hyperventilation

  MAUDE report 7716019 ↗
• InjuryJun 19, 2018Leak/Splash; Leak/Splash

  INFORMATION WAS RECEIVED INDICATING THAT THE CUFF OF THIS TRACHEOSTOMY TUBE LEAKED WHILE IN USE WITH A PATIENT; IT WOULD NOT HOLD WATER. IT WAS NOTED THAT THIS WAS A VENTILATOR-DEPENDENT PATIENT AND THE TRACHEOSTOMY TUBE HAD TO BE CHANGED OUT. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7616426 ↗
• InjuryDec 28, 2017Air Leak; Air Leak

  INFORMATION WAS RECEIVED INDICATING THAT AFTER THREE DAYS OF USE A LEAK WAS NOTED WITH THE CUFF OF THIS TRACHEOSTOMY TUBE. THIS TRACHEOSTOMY TUBE WAS REMOVED AND REPLACED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7152672 ↗
• InjuryOct 12, 2017Leak/Splash; Incomplete or Missing Packaging; Leak/Splash; Incomplete or Missing Packaging

  IT WAS REPORTED THAT A PORTEX® BIVONA® ADULT TTS¿ ADJUSTABLE NECK FLANGE HYPERFLEX¿ TRACHEOSTOMY TUBE DID NOT HAVE INSTRUCTIONS FOR USE EITHER ON OR INSIDE THE DEVICE PACKAGE. SPECIFICALLY, IT WAS NOT IDENTIFIED THAT THE CUFF MUST BE INFLATED WITH STERILE WATER. THIS RESULTED IN CAREGIVERS NOT BEING ABLE TO IDENTIFY LEAKS AROUND THE CUFF AS IT WAS ORIGINALLY INFLATED WITH AIR. THE EVENT REPORT TYPE WAS REPORTED AS SERIOUS INJURY, AND THE EVENT OUTCOME AS REQUIRED INTERVENTION. NO INFORMATION REGARDING THE TYPE OF INJURY OR INTERVENTION REQUIRED WAS PROVIDED. NO PERMANENT INJURY WAS REPORTED.

  Patient problems: No Information

  MAUDE report 6945673 ↗

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