Bivona CM3162NRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 15019517038866), received between May 3, 2017 and May 3, 2017 — classified as 1 malfunction.

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

• MalfunctionMay 3, 2017Air Leak; Air Leak

  IT WAS REPORTED THAT THE BALLOON OF A PORTEX® BIVONA® CUSTOM 6.5 A/C STANDARD NS TRACHEOSTOMY TUBE WAS LEAKING AFTER ONE WEEK IN USE. THE LEAK WAS NOTICED BY A PRIVATE DUTY NURSE DURING BEDSIDE CARE. CUFF PATENCY WAS TESTED PRIOR TO USE, AND THE CUFF WAS FILLED WITH AIR. VELCRO TRACHEOSTOMY TUBE TIES WERE USED TO HOLD THE DEVICE IN PLACE. THE NURSE CHANGED THE TRACHEOSTOMY TUBE. NO INJURY WAS REPORTED, AND THE EVENT WAS REPORTED AS RESOLVED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6541807 ↗

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.