Portex 27-9000Recalls & reported problems
Icu Medical, Inc. · Class 2
All models of Portex (409)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10788942290006), received between Apr 7, 2022 and Nov 18, 2025 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Packaging Problem” (1 report).
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.
Reports received per month
Most reported problems
Device problems
- Packaging Problem1
- Ventilation Problem in Device Environment1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionNov 18, 2025Ventilation Problem in Device Environment; Ventilation Problem in Device Environment
IT WAS REPORTED THAT THE DEVICE BECAME DRY AND WAS UNABLE TO INHALE OR DRAW AN AIR THROUGH. THE EVENT OCCURRED AFTER USING. THERE WAS A PATIENT INVOLVEMENT, BUT NO PATIENT INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23584622 ↗MalfunctionApr 7, 2022Packaging Problem; Packaging Problem
IT WAS REPORTED THAT THERE WAS INNER PACKING DEFECT ON THE ITEM. NO ADDITIONAL INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14043264 ↗
Other SPIROMETER, THERAPEUTIC (INCENTIVE) devices
- Portex 21-1530Icu Medical, Inc. · SPIROMETER, THERAPEUTIC (INCENTIVE)1 recall1 report
- HUDSON RCI IPN049141Teleflex Incorporated · SPIROMETER, THERAPEUTIC (INCENTIVE)3 reports
- HUDSON RCI IPN049316Teleflex Incorporated · SPIROMETER, THERAPEUTIC (INCENTIVE)3 reports
- Portex 22-4000Icu Medical, Inc. · SPIROMETER, THERAPEUTIC (INCENTIVE)2 reports
- HUDSON RCI IPN049142Teleflex Incorporated · SPIROMETER, THERAPEUTIC (INCENTIVE)1 report
- Portex 22-2500Icu Medical, Inc. · SPIROMETER, THERAPEUTIC (INCENTIVE)1 report
- Portex 27-9001Icu Medical, Inc. · SPIROMETER, THERAPEUTIC (INCENTIVE)1 report
- HUDSON RCI HUD8884719010Medline Industries, Inc. · SPIROMETER, THERAPEUTIC (INCENTIVE)1 report
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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