VentStar Flex 220 MP00355Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 04048675248996), received between Aug 29, 2024 and Feb 19, 2025 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Fracture” (2 reports).

1 FDA recall record name this device's identifier, 1 still open.

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.

Recalls naming this device

1. Mar 12, 2025Open, Classified

   The potential for cracks forming in the breathing circuit hose.

   Z-1493-2025 · Root cause: Under Investigation by firm · FDA record ↗

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 19, 2025Fracture; Gas/Air Leak; Fracture; Gas/Air Leak

  IT WAS REPORTED THAT THE PATIENT WAS INTUBATED, AND THE ANESTHESIOLOGIST CONFIRMED A LEAKAGE SOUND. WHEN CHECKED THE CIRCUIT, THE CIRCUIT HAD A CUT. NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21409152 ↗
• MalfunctionAug 29, 2024Fracture; Gas/Air Leak; Fracture; Gas/Air Leak

  IT WAS REPORTED THAT DURING SURGERY, THE CIRCUIT WAS CUT WHILE IT WAS PLACED IN THE CIRCUIT HOLDER. NO INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20095100 ↗