Portex 8520BMPRecalls & 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
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 15019517101119), received between May 13, 2021 and May 13, 2021 — classified as 1 malfunction.
The most frequently reported specific device problem is “Gas/Air Leak” (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.
Most reported problems
Device problems
- Gas/Air Leak1
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.
MalfunctionMay 13, 2021Gas/Air Leak; Gas/Air Leak
IT WAS REPORTED THE DEVICE WAS FOUND TO LEAK AND WOULD NOT HOLD PRESSURE. NO ADVERSE EFFECTS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11820120 ↗
Other Ventilator, emergency, manual (resuscitator) devices
- Ventlab AF5140MBVentlab, LLC · Ventilator, Emergency, Manual (Resuscitator)1 recall8 reports
- Curaplex AF2000Bound Tree Medical, LLC · Ventilator, emergency, manual (resuscitator)1 recall6 reports
- Ventlab AF5140MBPVentlab, LLC · Ventilator, Emergency, Manual (Resuscitator)1 recall5 reports
- Ventlab AF2140MBPVentlab, LLC · Ventilator, Emergency, Manual (Resuscitator)1 recall2 reports
- Ventlab AF5142MBPVentlab, LLC · Ventilator, Emergency, Manual (Resuscitator)1 recall2 reports
- Ventlab AF2142MC-3Ventlab, LLC · Ventilator, Emergency, Manual (Resuscitator)1 recall1 report
- Ventlab SS3200MB-MMCVentlab, LLC · Ventilator, Emergency, Manual (Resuscitator)1 recall1 report
- Medline CPRM1126FPWMMedline Industries, Inc. · Ventilator, emergency, manual (resuscitator)1 recall1 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
- 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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