Bivona XU21DS60NSC940NRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 15019517265224), received between Aug 18, 2021 and Feb 18, 2022 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Material Split, Cut or Torn” (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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 18, 2022Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT AFTER OPENING THE PACKAGE, THE PLASTIC SHEATH AROUND THE WIRE WAS FOUND TORN. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13561012 ↗
• InjuryAug 18, 2021Material Split, Cut or Torn; Material Split, Cut or Torn

  INFORMATION RECEIVED A SMITHS MEDICAL TRACHEOSTOMY/SILICONE - BIVONA TUBES CUSTOM PLASTIC SHEATH AROUND WIRE WAS TORN WHILE IN USE WITH THE PATIENT. CUSTOMER IS REQUESTING REPLACEMENTS.

  Patient problems: Insufficient Information

  MAUDE report 12338308 ↗

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.