Bivona HA14GS80NSC315NRecalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10351688761644), received between Mar 14, 2020 and Apr 24, 2023 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Inflation Problem” (2 reports).

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 18, 2026.

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 24, 2023Inflation Problem; Inflation Problem

  IT WAS REPORTED THAT UPON USING THE TRACH, IT WAS DEFECTIVE. A SECOND TRACH WAS USED, AND IT WAS DEFECTIVE AS WELL. AFTER APPLYING 24CC OF AIR, IT WAS ABLE TO DISPLACE ONE SIDE OF THE CUFF, BUT THE OTHER SIDE CONTINUED TO BE ADHERED AND REQUIRED AN ADDITIONAL 36CC-48CC OF AIR AND WOULD NOT DISPLACE. PLACED MULTIPLE SYRINGES OF SALINE TO DISPLACE AND THAT WOULD NOT WORK EITHER. AFTER PLACING 36-48 CC OF AIR WITH A LOT OF PRESSURE APPLIED TO MANIPULATE THE CUFF OFF THE TRACH AND IT WAS ABLE TO DISPLACE THE CUFF OFF THE TRACH SHAFT. IT WAS THE SAME ISSUE IN THE 2ND TRACH. THE NURSE BORROWED A TRACH FROM THE HOSPITAL TO RESOLVE THE SITUATION. NO INJURY WAS REPORTED. ( (B)(6) DOCUMENTS THAT FIRST ITEM AND (B)(6) DOCUMENTS THE SECOND ITEM).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16797301 ↗
• MalfunctionApr 24, 2023Inflation Problem; Inflation Problem

  IT WAS REPORTED THAT UPON USING THE TRACH, IT WAS DEFECTIVE. A SECOND TRACH WAS USED, AND IT WAS DEFECTIVE AS WELL. AFTER APPLYING 24CC OF AIR, IT WAS ABLE TO DISPLACE ONE SIDE OF THE CUFF, BUT THE OTHER SIDE CONTINUED TO BE ADHERED AND REQUIRED AN ADDITIONAL 36CC-48CC OF AIR AND WOULD NOT DISPLACE. PLACED MULTIPLE SYRINGES OF SALINE TO DISPLACE AND THAT WOULD NOT WORK EITHER. AFTER PLACING 36-48 CC OF AIR WITH A LOT OF PRESSURE APPLIED TO MANIPULATE THE CUFF OFF THE TRACH AND IT WAS ABLE TO DISPLACE THE CUFF OFF THE TRACH SHAFT. IT WAS THE SAME ISSUE IN THE 2ND TRACH. THE NURSE BORROWED A TRACH FROM THE HOSPITAL TO RESOLVE THE SITUATION. NO INJURY WAS REPORTED. (CC-0192752 DOCUMENTS THAT FIRST ITEM AND CC-0192849 DOCUMENTS THE SECOND ITEM).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16797101 ↗
• MalfunctionMar 14, 2020Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT THE PATIENT WAS NOCTURNALLY BEING VENTILATED WITH A CUSTOMIZED BIVONA TRACHEOSTOMY TUBE (TRACHS) AT THE TIME OF THE EVENT. UPON INSERTION, AND ALSO DURING THE CONTINUED USE OF THE DEVICE, THE CUFF WAS FIXED TO THE SHAFT IN MULTIPLE AREAS. THE CUFF WAS ALSO MANIPULATED VIA MASSAGING. DESPITE THIS BEING DONE HOWEVER, THE OPERATOR NOTED THAT THEY EXPERIENCED PROBLEMS WITH OBTAINING A VENTILATION SEAL. LEAKS WERE OBSERVED. THIS ISSUE WAS MORE PREVALENT WHEN THE PATIENT WAS SITTING UP, AS OPPOSED TO LAYING DOWN TO SLEEP. THE OPERATOR ATTEMPTED TO PASS MORE AIR INTO THE CUFF BUT THE ISSUE PERSISTED. IT SHOULD BE NOTED THAT NO DIFFICULTIES WERE EXPERIENCED WHEN THE CUFF WAS INITIALLY BEING INFLATED. EVEN WHEN THE TRACHEOSTOMY TUBE WAS REMOVED FROM THE PATIENT, THE CUFF WAS STILL ADHERING TO THE SHAFT. THIS ISSUE WAS OBSERVED EVEN AFTER THE CUFF WAS HYPER INFLATED. NO PATIENT INJURY OR COMPLICATIONS WERE REPORTED IN RELATION TO THIS EVENT. AS A RESULT OF THE AFOREMENTIONED PRODUCT PROBLEM, THE PATIENT RESORTED TO USING TRACHEOSTOMY TUBES FROM A PREVIOUS ORDER (YEAR 2016). EVEN WITH THIS, THE PATIENT WAS WORRIED THAT THE BALLOON LINE, OR BALLOON VALVE, COULD POTENTIALLY

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9833004 ↗
• MalfunctionMar 14, 2020Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT THE PATIENT WAS NOCTURNALLY BEING VENTILATED WITH A CUSTOMIZED BIVONA TRACHEOSTOMY TUBE (TRACHS) AT THE TIME OF THE EVENT. UPON INSERTION, AND ALSO DURING THE CONTINUED USE OF THE DEVICE, THE CUFF WAS FIXED TO THE SHAFT IN MULTIPLE AREAS. THE CUFF WAS ALSO MANIPULATED VIA MASSAGING. DESPITE THIS BEING DONE HOWEVER, THE OPERATOR NOTED THAT THEY EXPERIENCED PROBLEMS WITH OBTAINING A VENTILATION SEAL. LEAKS WERE OBSERVED. THIS ISSUE WAS MORE PREVALENT WHEN THE PATIENT WAS SITTING UP, AS OPPOSED TO LAYING DOWN TO SLEEP. THE OPERATOR ATTEMPTED TO PASS MORE AIR INTO THE CUFF BUT THE ISSUE PERSISTED. IT SHOULD BE NOTED THAT NO DIFFICULTIES WERE EXPERIENCED WHEN THE CUFF WAS INITIALLY BEING INFLATED. EVEN WHEN THE TRACHEOSTOMY TUBE WAS REMOVED FROM THE PATIENT, THE CUFF WAS STILL ADHERING TO THE SHAFT. THIS ISSUE WAS OBSERVED EVEN AFTER THE CUFF WAS HYPER INFLATED. NO PATIENT INJURY OR COMPLICATIONS WERE REPORTED IN RELATION TO THIS EVENT. AS A RESULT OF THE AFOREMENTIONED PRODUCT PROBLEM, THE PATIENT RESORTED TO USING TRACHEOSTOMY TUBES FROM A PREVIOUS ORDER (YEAR 2016). EVEN WITH THIS, THE PATIENT WAS WORRIED THAT THE BALLOON LINE, OR BALLOON VALVE, COULD POTENTIALLY

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9832993 ↗

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.