Portex 21-1530Recalls & reported problems
Icu Medical, Inc. · Class 2
All models of Portex (409)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10788942215306), received between Dec 10, 2024 and Dec 10, 2024 — classified as 1 malfunction.
The most frequently reported specific device problem is “Break” (1 report).
1 FDA recall record name this device's identifier.
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.
Reports received per month
Recalls naming this device
- Dec 21, 2020Class IITerminated
Shipping box may contain wrong model.
Z-0874-2021 · Root cause: Nonconforming Material/Component · Recall details · FDA record ↗
Most reported problems
Device problems
- Break1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionDec 10, 2024Break; Break
IT WAS REPORTED THAT WHEN THE CUSTOMER BLEW ON THE DEVICE, THE LITTLE FAN DID NOT SPIN. THE DEVICE WAS OPERATED BY THE LAY USER/PATIENT AT THE PATIENT'S HOME. THERE WAS PATIENT INVOLVEMENT, AND NO PATIENT HARM/ADVERSE EVENT REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20892887 ↗
Other SPIROMETER, THERAPEUTIC (INCENTIVE) devices
- HUDSON RCI IPN049316Teleflex Incorporated · SPIROMETER, THERAPEUTIC (INCENTIVE)3 reports
- HUDSON RCI IPN049141Teleflex Incorporated · SPIROMETER, THERAPEUTIC (INCENTIVE)3 reports
- Portex 22-4000Icu Medical, Inc. · SPIROMETER, THERAPEUTIC (INCENTIVE)2 reports
- Portex 27-9000Icu Medical, Inc. · SPIROMETER, THERAPEUTIC (INCENTIVE)2 reports
- Portex 27-9001Icu Medical, Inc. · SPIROMETER, THERAPEUTIC (INCENTIVE)1 report
- Portex 22-2500Icu Medical, Inc. · SPIROMETER, THERAPEUTIC (INCENTIVE)1 report
- HUDSON RCI HUD8884719010Medline Industries, Inc. · SPIROMETER, THERAPEUTIC (INCENTIVE)1 report
- Portex 23-0757Icu Medical, 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 16, 2026 · each recall links to the FDA recall notice
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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