Bivona ZT25LN25NGE261NRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10887709182049), received between Mar 18, 2026 and Mar 18, 2026 — classified as 1 malfunction.

The most frequently reported specific device problem is “Difficult to Insert” (1 report).

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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 18, 2026Difficult to Insert; Suction Failure

  IT WAS REPORTED THAT THE DEVICE DID NOT ALLOW THE 8FR SUCTION CATHETER TO PASS SMOOTHLY WITHOUT SOME RESISTANCE. WHILE THE DEVICE WAS IN USE ON A PATIENT, THE TUBE HAD ALREADY BEEN INSERTED, AND THE ISSUE WAS NOT NOTICED UNTIL AFTER PLACEMENT WHEN SUCTION WAS INITIATED TO CLEAR SECRETIONS. THE SUCTION CATHETER COULD NOT BE INSERTED PROPERLY. THE BEDSIDE TEAM WAS ABLE TO REPLACE THE TUBE WITH THE PATIENT¿S ORIGINAL TRACH, BUT THIS RESULTED IN AN UNPLANNED TRACH CHANGE. MEDICATION INTERVENTION WAS REQUIRED BECAUSE THE PATIENT HAD TO BE SWITCHED BACK TO THE ORIGINAL TRACH, AS THE CUSTOM TUBES WERE NOT PATENT ENOUGH FOR 8 FR SUCTION CATHETERS. THE ISSUE WAS EVENTUALLY RESOLVED, BUT IT TOOK A THIRD SET OF TUBES TO OBTAIN ONES THAT WERE PATENT. THE PATIENT HAD TO REMAIN STRAPPED DOWN WITH THE NECK HYPEREXTENDED WHILE WAITING FOR THE CUSTOM TUBES, AND BECAUSE THE TUBES WERE NOT PATENT, THE PATIENT STAYED IN THAT POSITION UNTIL THE THIRD SET ARRIVED AND WAS CONFIRMED USABLE. THE PATIENT¿S DATE OF BIRTH WAS (B)(6) 2025; THE PATIENT WAS 4 MONTHS OLD DURING THE EVENT, WEIGHED 5.74 KG, AND WAS OF NON-HISPANIC/OTHER RACE. THERE WAS NO REPORTED PATIENT HARM.

  Patient problems: Hyperextension

  MAUDE report 24630692 ↗

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.