Bivona 67NFPS30Recalls & reported problems

Summary

The FDA's MAUDE database contains 23 adverse event reports that list this exact device (DI 10351688518781), received between Oct 16, 2017 and Nov 26, 2025 — classified as 4 injuries, 19 malfunctions.

The most frequently reported specific device problem is “Inflation Problem” (9 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-2609-2024 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 23 most recent of 23 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 26, 2025Obstruction of Flow; Obstruction of Flow

  IT WAS REPORTED THAT THE TRACH PLACED. UNABLE TO PASS SUCTION CATHETER. ENT SCOPED AND NOTED OBSTRUCTION INSIDE TRACH TUBE. THERE WAS PATIENT INVOLVEMENT AND THERE WAS NO PATIENT HARM. EVENT OCCURRED DURING IMMEDIATE ON USE AT THE HOSPITAL, AND IT WAS OPERATED BY A HEALTH PROFESSIONAL. THE PATIENT INITIAL IS SH, A FEMALE. SHE 3-MONTH-OLD, 5.52 KG. SHE WAS A NON-HISPANIC/LATINO, AND A WHITE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23661449 ↗
• InjuryOct 18, 2024Complete Blockage; Failure to Deflate; Complete Blockage; Failure to Deflate

  IT WAS REPORTED THAT FOLLOWING INSERTION OF THE TRACHEOSTOMY AND FILLING OF THE CUFF WITH STERILE WATER, THE CUFF LOOKED OVERLY FULL. THE NURSE PERFORMING THE PROCEDURE WAS INFORMED OF THE INTENTION TO REMOVE THE WATER FROM THE CUFF FOR VERIFICATION. UPON ATTEMPTING TO DEFLATE THE CUFF, NO WATER COULD BE EXTRACTED. THE NURSE IN CHARGE AND A DOCTOR WERE CALLED, BOTH OF WHOM WERE ALSO UNABLE TO REMOVE THE WATER FROM THE CUFF. A DECISION WAS MADE TO ATTEMPT REMOVAL OF THE TRACHEOSTOMY WITH THE CUFF STILL INFLATED, ENSURING NO TRAUMA WOULD OCCUR. THE TRACHEOSTOMY WAS SUCCESSFULLY REMOVED. THERE WAS PATIENT INVOLVEMENT, AND NO PATIENT HARM/ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20487082 ↗
• MalfunctionOct 7, 2024Inflation Problem; Inflation Problem

  IT WAS REPORTED THAT THE OUTSIDE BALLOON INFLATES, INNER CANNULA BALLOON INTERNAL TO PATIENT DOES NOT. BALLOON WAS CHECKED PRIOR TO FIRST USE. THERE WAS NO PATIENT INVOLVEMENT, AND NO PATIENT HARM/ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20386331 ↗
• MalfunctionJan 24, 2024Inflation Problem; Inflation Problem

  IT WAS REPORTED THAT THE TRACH WAS DEFECTIVE. THE CUFF DID NOT INFLATE PROPERLY. NO PATIENT INVOLVEMENT AND NO PATIENT HARM/ADVERSE EVENT REPORTED. A DIFFERENT TRACH WAS AVAILABLE TO USE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18575988 ↗
• MalfunctionDec 22, 2023Defective Component; Defective Component

  IT WAS REPORTED THAT THE USER EXPERIENCED DIFFICULTY FROM THE BALLOON IN THE CANNULA. IT WAS REPORTED AS "DEFECTIVE. EPPI REMAINED IN THE SPOTLIGHT. INEFFECTIVENESS OF NOCTURNAL NIV (NON-INVASIVE VENTILATION)." MORE INFORMATION WAS OBTAINED INDICATING THAT THE REPORTED PROBLEM OCCURRED DURING USE ON THE PATIENT. NO MEDICAL INTERVENTION REQUIRED. NO CLINICAL CONSEQUENCES. NO MEDICAL TREATMENT. THE STATUS OF THIS INCIDENT WAS REPORTED AS "ONGOING". UNKNOWN MEDICATION INVOLVED IN THE EVENT. RESOLUTION TO THE EVENT WAS NOT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18381241 ↗
• MalfunctionDec 21, 2023Defective Component; Defective Component

  IT WAS REPORTED THAT THE USER EXPERIENCED DIFFICULTY FROM THE BALLOON IN THE CANNULA. IT WAS REPORTED AS "DEFECTIVE. EPPI REMAINED IN THE SPOTLIGHT. INEFFECTIVENESS OF NOCTURNAL NIV (NON-INVASIVE VENTILATION)." MORE INFORMATION WAS OBTAINED INDICATING THAT THE REPORTED PROBLEM OCCURRED DURING USE ON THE PATIENT. NO MEDICAL INTERVENTION REQUIRED. NO CLINICAL CONSEQUENCES. NO MEDICAL TREATMENT. THE STATUS OF THIS INCIDENT WAS REPORTED AS "ONGOING". UNKNOWN MEDICATION INVOLVED IN THE EVENT. RESOLUTION TO THE EVENT WAS NOT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18379787 ↗
• MalfunctionDec 21, 2023Defective Component; Defective Component

  IT WAS REPORTED THAT THE USER EXPERIENCED DIFFICULTY FROM THE BALLOON IN THE CANNULA. IT WAS REPORTED AS "DEFECTIVE. EPPI REMAINED IN THE SPOTLIGHT. INEFFECTIVENESS OF NOCTURNAL NIV (NON-INVASIVE VENTILATION)." MORE INFORMATION WAS OBTAINED INDICATING THAT THE REPORTED PROBLEM OCCURRED DURING USE ON THE PATIENT. NO MEDICAL INTERVENTION REQUIRED. NO CLINICAL CONSEQUENCES. NO MEDICAL TREATMENT. THE STATUS OF THIS INCIDENT WAS REPORTED AS "ONGOING". UNKNOWN MEDICATION INVOLVED IN THE EVENT. RESOLUTION TO THE EVENT WAS NOT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18379295 ↗
• MalfunctionDec 21, 2023Defective Component; Defective Component

  IT WAS REPORTED THAT THE USER EXPERIENCED DIFFICULTY FROM THE BALLOON IN THE CANNULA. IT WAS REPORTED AS "DEFECTIVE. EPPI REMAINED IN THE SPOTLIGHT. INEFFECTIVENESS OF NOCTURNAL NIV (NON-INVASIVE VENTILATION)." MORE INFORMATION WAS OBTAINED INDICATING THAT THE REPORTED PROBLEM OCCURRED DURING USE ON THE PATIENT. NO MEDICAL INTERVENTION REQUIRED. NO CLINICAL CONSEQUENCES. NO MEDICAL TREATMENT. THE STATUS OF THIS INCIDENT WAS REPORTED AS "ONGOING". UNKNOWN MEDICATION INVOLVED IN THE EVENT. RESOLUTION TO THE EVENT WAS NOT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18376532 ↗
• MalfunctionDec 21, 2023Defective Component; Defective Component

  IT WAS REPORTED THAT THE USER EXPERIENCED DIFFICULTY FROM THE BALLOON IN THE CANNULA. IT WAS REPORTED AS "DEFECTIVE. EPPI REMAINED IN THE SPOTLIGHT. INEFFECTIVENESS OF NOCTURNAL NIV (NON-INVASIVE VENTILATION)." MORE INFORMATION WAS OBTAINED INDICATING THAT THE REPORTED PROBLEM OCCURRED DURING USE ON THE PATIENT. NO MEDICAL INTERVENTION REQUIRED. NO CLINICAL CONSEQUENCES. NO MEDICAL TREATMENT. THE STATUS OF THIS INCIDENT WAS REPORTED AS "ONGOING". UNKNOWN MEDICATION INVOLVED IN THE EVENT. RESOLUTION TO THE EVENT WAS NOT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18376097 ↗
• 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 17691795 ↗
• MalfunctionMay 10, 2023Inflation Problem; Inflation Problem

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16900360 ↗
• MalfunctionApr 7, 2023Material Deformation; Material Deformation

  IT WAS REPORTED THAT THE BALLOON INFLATES LOPSIDED WHEN SALINE PLACED VIA CUFF. ADDITIONAL INFORMATION RECEIVED VIA CUSTOMER RESPONSE EMAIL 26-AUG-2022: PATIENT WAS NOT HARMED, AS TRACH WAS NEVER PLACED. THIS TRACH'S BALLOON IS DEFORMED, LOPSIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16701028 ↗
• MalfunctionDec 28, 2022Unintended Deflation; Unintended Deflation

  IT WAS REPORTED THAT THREE TRACHEOSTOMY TUBES HAD CUFFS DEFLATE PRIOR TO USE. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16062061 ↗
• MalfunctionSep 20, 2022Defective Device; Defective Device

  IT WAS REPORTED THAT THE CUFF WILL NOT INFLATE. THE INFLATION LINE WAS MANIPULATED TO TRY AND COAX WATER IN THE CUFF BUT IT WOULD STILL NOT INFLATE: NO PATIENT INJURY WAS REPORTED

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15460043 ↗
• MalfunctionSep 20, 2022Inflation Problem; Inflation Problem

  IT WAS REPORTED THAT MULTIPLE TRACHEOSTOMY'S FAILED TO INFLATE DURING PRE-TEST. MULTIPLE LOTS AFFECTED WITH 11 TRACHEOSTOMY'S IN TOTAL. NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15460036 ↗
• MalfunctionMar 28, 2022Inflation Problem; Inflation Problem

  IT WAS REPORTED THAT THE CUFF DIDN'T INFLATE. THERE WAS NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13928248 ↗
• MalfunctionJun 16, 2021Inflation Problem; Inflation Problem

  INFORMATION RECEIVED A SMITHS MEDICAL TRACHEOSTOMY/SILICONE - BIVONA TUBES NEO/PED FLEXTEND CUFFS WERE NOT INFLATING WHEN TESTED. THE REPORT BY A NURSE STATED THE BABY WAS HAVING RESPIRATORY STATUS WORSENING WITH FEEDING AND OXYGEN NEEDED TO BE INCREASED WITH PATIENT SUCTIONED AND PERCUSSED SUPINE AND PRONE. RTT WAS SUMMONED AND A TRACH CHANGE WAS DONE, AFTER FOUR TIMES TRYING THE PATIENT REQUIRED ATROVENT EXTRA DOSE WITH REPORT OF PATIENT RESTING COMFORTABLE AFTER INTERVENTION.

  Patient problems: Airway Obstruction

  MAUDE report 12009343 ↗
• MalfunctionDec 21, 2020Inflation Problem; Inflation Problem

  INFORMATION WAS RECEIVED INDICATING THAT A SMITHS MEDICAL TRACH DID NOT INFLATE. THERE WERE NO REPORTED ADVERSE EVENTS.

  Patient problems: No Information

  MAUDE report 11046441 ↗
• MalfunctionNov 18, 2019Malposition of Device; Output Problem; Malposition of Device; Output Problem

  INFORMATION WAS RECEIVED THAT WHILE A SMITHS MEDICAL TRACHEOSTOMY HAS A CANNULA AND FLANGE THAT ARE MOVABLE. THE OBTURATOR NEEDS TO BE INSERTED IN ORDER TO PLACE THE TRACHEOSTOMY TUBE. THE FLANGE DOES NOT HAVE DIRECTIONAL ORIENTATION TO IT. NO ADVERSE EFFECTS HAVE BEEN REPORTED.

  Patient problems: No Information; Respiratory Distress

  MAUDE report 9336966 ↗
• InjuryOct 25, 2019Installation-Related Problem; Installation-Related Problem

  IT WAS REPORTED THAT WHILE REPLACING A TRACHEOSTOMY TUBE (TRACH), VIA A BLIND PLACEMENT, ON SMALL CHILD IN A TURTLE SHELL BODY CAST, THE OPERATOR INADVERTENTLY INSERTED THE OBTURATOR AND PLACED THE TRACH UPSIDE DOWN (IN A FLIPPED POSITION). THIS RESULTED IN THE CHILD EXPERIENCING RESPIRATORY DISTRESS, LIKELY FROM THE DISTAL CURVATURE OF THE TRACH. THE OPERATOR SUBSEQUENTLY REMOVED THE TRACH TUBE AND REINSERTED IT CORRECTLY. NO PATIENT INJURY OR FURTHER COMPLICATIONS WERE REPORTED IN RELATION TO THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9239912 ↗
• MalfunctionDec 19, 2017Inflation Problem

  THE RN ACTING AS SCRUB FOR THE PROCEDURE TESTED THE CUFF BALLOON PRIOR TO PROCEDURE START AND ONLY HALF OF THE BALLOON INFLATED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7128131 ↗
• InjuryOct 17, 2017Obstruction of Flow; Material Integrity Problem; Obstruction of Flow; Material Integrity Problem

  IT WAS REPORTED THAT A SMITHS MEDICAL PORTEX® BIVONA FLEXTEND¿ TTS¿ TRACHEOSTOMY TUBE DID NOT INFLATE WHEN ATTEMPTED TO BE FILLED WITH STERILE WATER. THE BALLOON TO THE TRACHEOSTOMY BULGED WITH NO NOTED STERILE WATER REACHING THE CUFF AND WAS THOUGHT TO BE OCCLUDED. SUBSEQUENTLY, THE PATIENT REQUIRED ENDOTRACHEAL INTUBATION TO SECURE THE AIRWAY. NO FURTHER ADVERSE PATIENT'S EFFECTS WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6954695 ↗
• InjuryOct 16, 2017Obstruction of Flow; Material Integrity Problem; Obstruction of Flow; Material Integrity Problem

  IT WAS REPORTED THAT A SMITHS MEDICAL PORTEX® BIVONA FLEXTEND¿ TTS¿ TRACHEOSTOMY TUBE DID NOT INFLATE WHEN ATTEMPTED TO BE FILLED WITH STERILE WATER. THE BALLOON TO THE TRACHEOSTOMY BULGED WITH NO NOTED STERILE WATER REACHING THE CUFF AND WAS THOUGHT TO BE OCCLUDED. SUBSEQUENTLY, THE PATIENT REQUIRED ENDOTRACHEAL INTUBATION TO SECURE THE AIRWAY. NO FURTHER ADVERSE PATIENT'S EFFECTS WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6952375 ↗

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.