First Choice UHP7588Recalls & 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
- 3
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 08570590020259), received between Nov 12, 2018 and Apr 15, 2022 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Material Puncture/Hole” (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
- Material Puncture/Hole1
- Material Rupture1
- Material Separation1
- Mechanical Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
- No Known Impact Or Consequence To Patient1
- Renal Failure1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionApr 15, 2022Mechanical Problem; Mechanical Problem
CUSTOMER REPORTS WHEN INFLATING BALLOON TO 22PSI, WHICH WAS THE TARGET, THE BALLOON BURST AT 21 PSI. THERE WAS NO PATIENT INJURY REPORTED. MINOR PROCEDURAL DELAYED WAS REPORT WHILE THE NEW DEVICE WAS PREPPED AND INSERTED. THE NEW DEVICE WAS USED TO COMPLETE THE PROCEDURE.
Patient problems: Renal Failure
MAUDE report 14118608 ↗MalfunctionSep 14, 2020Material Rupture; Material Separation; Material Rupture; Material Separation
FOLLOW UP REPORT FOR (B)(6); MFR REPORT #: 3005994106-2020-00091.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 10527445 ↗MalfunctionNov 12, 2018Material Puncture/Hole
DURING PROCEDURE BALLOON POPPED WHEN THEY TOOK IT OUT THERE WAS A PIN HOLE PRESENT. THERE WAS NO PATIENT INJURY FROM THE EVENT.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8059099 ↗
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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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