Vyntus V-707327Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 14250892901432), received between Dec 16, 2020 and Dec 16, 2020 — classified as 1 malfunction.

The most frequently reported specific device problem is “Mechanical Problem” (1 report).

1 other recall cover devices cleared under the same FDA submission (K150810); 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. How this data works · Data updated Oct 13, 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.

• MalfunctionDec 16, 2020Mechanical Problem; Mechanical Problem

  IT WAS REPORTED TO VYAIRE THAT THE LITTLE CLEAR TUBE AT THE END OF THE TWINTUBE COLLECTION SAMPLE LINE BROKE OFF. THIS IS CLOSE TO THE PATIENT'S FACE, WHERE THEY ARE BREATHING THROUGH A MASK. THERE IS RISK OF PART BEING ASPIRATED OR INGESTED. THE CUSTOMER CONFIRMED THAT THERE WAS NO PATIENT HARM ASSOCIATED WITH THIS REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11016345 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K150810. One submission often covers many models, so check the product and lot details in each record.

• Z-1730-2024 · Apr 8, 2024 · Open, Classified
  Vyaire Medical GmbH, Vyaire Twin Tube sample line 240 cm, Model Number V-707327; The TwinTube sample line 240cm is used in the Vyntus CPX. The TwinTube sample line 240cm is connect