Bivona CM3289NRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 15019517080490), received between Jun 14, 2017 and Aug 9, 2018 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Crack” (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 16, 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.

• InjuryAug 9, 2018Crack; Disconnection; Crack; Disconnection

  INFORMATION WAS RECEIVED THAT THE BIVONA TRACH TUBE WAS DISCONNECTED FROM THE ISO CONNECTOR THE ISO CONNECTOR DETACHED FROM THE REST OF THE CANNULA LEAVING NO CONNECTION TO THE VENTILATOR. A NEW CANNULA WAS INSERTED PROMPTLY TO VENTILATE THE PATIENT. THIS INCIDENT OCCURRED AFTER APPROXIMATELY 11 MONTHS OF USE. NO PERMANENT DAMAGE REPORTED.

  Patient problems: Suffocation

  MAUDE report 7767805 ↗
• MalfunctionJun 14, 2017Defective Device; Defective Device

  IT WAS REPORTED THAT DURING QA INSPECTION, IT WAS OBSERVED THAT THE "CYLINDRICAL PART IN SILICONE AGAINST THE ISO-15 CONNECTOR" OF A PORTEX® BIVONA® CUSTOM TRACHEOSTOMY TUBE IS "PROLONGED" THAN THE STANDARD MPT FLANGE. BECAUSE THE DEVIATION WAS OBSERVED DURING A PRE-USE INSPECTION, THERE WAS NO PATIENT INVOLVEMENT OR INJURY.

  Patient problems: No Patient Involvement

  MAUDE report 6641104 ↗

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.