First Choice UHP7594Recalls & reported problems
Creagh Medical Limited · Class 2
All models of First Choice (9)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 08570590020075), received between Sep 23, 2024 and Sep 23, 2024 — classified as 1 injury.
The most frequently reported specific device problem is “Fracture” (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 18, 2026.
Reports received per month
Most reported problems
Device problems
- Fracture1
- Material Separation1
- Off-Label Use1
Patient problems
- Foreign Body In Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjurySep 23, 2024Fracture; Off-Label Use; Material Separation; Fracture; Off-Label Use; Material Separation
THE PATIENT PRESENT FOR A FISTALGRAM AND ANGIOPLASTY PROCEDURE. IT WAS DETERMINED THE CEPHALIC ARCH WAS APPROXIMATELY 80% STENOSED. THE HIGH PRESSURE BALLOON INFLATIONS WERE PERFORMED. MODERATE WASTE NOTED, FOLLOWED BY FULL EFFACEMENT AT 22ATM. THE BALLOON WAS DEFLATED AND EASILY REMOVED. THE STENOSIS WAS REEVALUATED WITH CONTRAST INJECTION. SIGNIFICANT STENOSIS PRESENCE WAS IDENTIFIED AND STENT PLACEMENT WAS PERFORMED. THE BALLOON WAS ADVANCED OVER WIRE AND INFLATIONS PERFORMED. THE BALLOON WAS USED TO FULLY EXPAND THE STENT AND SET IN PLACE AGAINST THE VESSEL WALL. THE INTENTION WAS TO INFLATE THE BALLOON TO 20ATM. HOWEVER, THE BALLOON RUPTURED AT 16ATM. THE BALLOON WAS DIFFICULT TO REMOVE AS IT APPEARED TO BE STUCK TO NEWLY PLACED STENT. WITH MUCH DIFFICULTY BALLOON WAS ABLE TO BE PULLED FOLLOWED BY SHEATH REMOVAL. EXAMINATION OF THE BROKEN BALLOON WAS THEN PERFORMED. THE BALLOON WAS DETERMINED TO HAVE RUPTURED TRANSVERSELY WITH HALF OUT OF THE BODY AND OTHER HALF REMAINING INSIDE. THE REMAINING BALLOON WAS ULTIMATELY ABLE TO BE REMOVED OVER THE WIRE WITH FORCE. FOLLOWING BALLOON REMOVAL, THE GUIDEWIRE WAS ABLE TO MOVE FREELY. UNDER HIGH MAGNIFICATION AREA OF SHEATH WAS PRESENT
Patient problems: Foreign Body In Patient
MAUDE report 20285557 ↗
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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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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