Bivona 750160Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 15021312006407), received between Dec 30, 2019 and Oct 13, 2022 — classified as 12 malfunctions.

The most frequently reported specific device problem is “Inflation Problem” (7 reports).

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

5 other recalls cover devices cleared under the same FDA submission (K083641, K914088); 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-2589-2024 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 13, 2022Loose or Intermittent Connection; Loose or Intermittent Connection

  IT WAS REPORTED THAT THE DEVICE'S CUFF CONNECTION BECAME LOOSE. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15598883 ↗
• MalfunctionSep 20, 2022Inflation Problem; Inflation Problem

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15460020 ↗
• MalfunctionSep 19, 2022Inflation Problem; Inflation Problem

  IT WAS REPORTED THAT DURING A PRE-USE CHECK, THE CUSTOMER NOTICED THE CUFF DID NOT INFLATE. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15446297 ↗
• MalfunctionSep 13, 2022Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT THE DEVICE WAS NOT INFLATING PROPERLY DURING PRE-USE CHECK. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15410754 ↗
• MalfunctionSep 13, 2022Short Fill; Short Fill

  IT WAS REPORTED THAT DURING A PRE-USE TEST, THE CUSTOMER NOTICED THE CUFF DID NOT INFLATE NORMALLY. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15410577 ↗
• MalfunctionSep 2, 2022Inflation Problem; Physical Resistance/Sticking; Inflation Problem; Physical Resistance/Sticking

  IT WAS REPORTED THAT DURING PRE-TEST, THE CUFF WAS STICKING WHICH WAS NOT ALLOWING FOR INFLATION. NO PATIENT INJURY. NO ADDITIONAL INFORMATION IS AVAILABLE FOR THIS COMPLAINT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15353159 ↗
• MalfunctionSep 2, 2022Inflation Problem; Physical Resistance/Sticking; Inflation Problem; Physical Resistance/Sticking

  IT WAS REPORTED THAT DURING THE PRE-USE CHECK, THE CUFF GOT STUCK TO THE OTHER PART OF ITSELF, WHICH DID NOT ALLOW IT TO BE INFLATED. NO PATIENT INJURY OR ADVERSE AFFECTS. NO ADDITIONAL INFORMATION IS AVAILABLE FOR THIS COMPLAINT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15352698 ↗
• MalfunctionFeb 18, 2022Inflation Problem; Inflation Problem

  IT WAS REPORTED THAT DURING THE PRE-USE CHECK, THE CUFF WAS FOUND STUCK TO THE TUBE, WHICH DID NOT ALLOW THE CUFF TO BE INFLATED. NO PATIENT INJURY. NO ADDITIONAL INFORMATION IS AVAILABLE FOR THIS COMPLAINT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13559669 ↗
• MalfunctionFeb 18, 2022Inflation Problem; Inflation Problem

  IT WAS REPORTED THAT DURING THE PRE-USE CHECK, THE CUFF WAS FOUND STUCK TO THE TUBE, WHICH DID NOT ALLOW THE CUFF TO BE INFLATED. NO PATIENT INJURY. NO ADDITIONAL INFORMATION IS AVAILABLE FOR THIS COMPLAINT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13559573 ↗
• MalfunctionFeb 17, 2022Inflation Problem; Inflation Problem

  IT WAS REPORTED THAT DURING THE PRE-USE CHECK, THE CUFF WAS FOUND STUCK TO THE TUBE, WHICH DID NOT ALLOW THE CUFF TO BE INFLATED. NO PATIENT INJURY. NO ADDITIONAL INFORMATION IS AVAILABLE FOR THIS COMPLAINT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13550037 ↗
• MalfunctionMar 17, 2020Obstruction of Flow; Obstruction of Flow

  INFORMATION WAS RECEIVED INDICATING THAT THE CUFF TO A SMITHS MEDICAL PORTEX® BIVONA® AIRE-CUF® TRACHEOSTOMY TUBE COULD NOT BE BLOCKED DURING CHANGE OUT. THERE WERE NO REPORTED ADVERSE EFFECTS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9845357 ↗
• MalfunctionDec 30, 2019Gas/Air Leak; Gas/Air Leak

  INFORMATION WAS RECEIVED THAT A SMITHS MEDICAL BIVONA AIRE-CUF 6.0 MM TRACHEOSTOMY TUBE WAS PLACED WITH A PATIENT ON (B)(6) 2019 AT THE HOSPITAL. THE REPORTER STATED THAT THEY "NEED TO REFILL THE CUFF MORE OFTEN THAN THEY USED TO. IT IS NOT ONLY 1 ML, BUT 3-4 ML EVERY 6 HOUR." IT WAS ALSO REPORTED THE USER WANTED TO WAIT TO REPLACE THE TUBE UNTIL THE PATIENT'S PLANNED CHANGE OUT DATE. THEY WILL CONTINUE TO REFILL THE CUFF WITH AIR. THERE WERE NO ADVERSE PATIENT EFFECTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 9532675 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K083641, K914088. One submission often covers many models, so check the product and lot details in each record.

• Z-0205-2024 · Aug 22, 2023 · Open, Classified
  Smiths Medical Portex Bivona Pediatric Tracheostomy Tube, Cuffless, Model 60P045, Sterile.
• Z-2946-2020 · Aug 28, 2020 · Terminated
  Bivona Mid-Range Aire-Cuf Adult Tracheostomy Tube This tube is intended to provide direct airway access for a tracheotomized patient for up to 29 days. It may be reprocessed up to
• Z-1465-2017 · Feb 9, 2017 · Terminated
  Bivona TTS (Tight to Shaft) Pediatric Tracheostomy Tube, Model No. 67SP035, Reorder No. 67SP035.
• Z-0930-05 · Apr 26, 2005 · Terminated
  Bivona brand Pediatric TTS Tracheostomy Tube, 3.5 mm tracheostomy tubes with a 3.5mm obturator ; product code 67P035.
• Z-0302-06 · Feb 17, 2005 · Terminated
  Bivona brand Neonatal TTS Tracheostomy Tubes, sterile, product code 67N040.