First Choice UHP7584Recalls & reported problems
Creagh Medical Limited · Class 2
All models of First Choice (9)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 4
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 08570590020068), received between Oct 7, 2020 and Oct 7, 2020 — classified as 4 malfunctions.
The most frequently reported specific device problem is “Difficult to Open or Close” (3 reports).
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
- Difficult to Open or Close3
- Failure to Deflate3
- Explosion1
- Inflation Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions4
- Insufficient Information2
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
MalfunctionOct 7, 2020Difficult to Open or Close; Failure to Deflate; Difficult to Open or Close; Failure to Deflate
FOLLOW UP REPORT FOR CC2020-097-IR; MFR REPORT #: 3005994106-2020-00097.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 10645773 ↗MalfunctionOct 7, 2020Inflation Problem; Explosion; Inflation Problem; Explosion
FOLLOW UP REPORT FOR CC2020-099-IR; MFR REPORT #: 3005994106-2020-00099.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 10645772 ↗MalfunctionOct 7, 2020Difficult to Open or Close; Failure to Deflate; Difficult to Open or Close; Failure to Deflate
FOLLOW UP REPORT FOR CC2020-096-IR; MFR REPORT #: 3005994106-2020-00096.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 10645757 ↗MalfunctionOct 7, 2020Difficult to Open or Close; Failure to Deflate; Difficult to Open or Close; Failure to Deflate
FOLLOW UP REPORT FOR CC2020-098-IR; MFR REPORT #: 3005994106-2020-00098
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 10645749 ↗
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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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