Bivona ST19IN70NSC020NRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 15019517204179), received between Aug 26, 2022 and Nov 13, 2023 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Break” (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.

• MalfunctionNov 13, 2023Break; Material Separation; Break; Material Separation

  IT WAS REPORTED THAT THE CUFF WAS DAMAGED. PATIENT INVOLVEMENT UNKNOWN.

  Patient problems: Insufficient Information

  MAUDE report 18124121 ↗
• MalfunctionAug 26, 2022Break; Break

  IT WAS REPORTED THAT THE CUSTOMER RECEIVED A DAMAGED CUSTOM TRACH TUBE - ONE OF THE FLANGES TO SECURE THE TRACH IS BROKEN. PATIENT HAD ANOTHER TRACH TUBE IN THEIR HOME THAT THEY WERE ABLE TO USE. REPORTED LOT NUMBER CANNOT BE CONFIRMED FOR MANUFACTURE AND EXPIRATION DATES OF PRODUCT. NO PATIENT INJURY OR ADVERSE AFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15304370 ↗

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.