First Choice UHP75104Recalls & 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
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 08570590020082), received between Dec 20, 2018 and Mar 11, 2021 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Material Rupture” (2 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
- Material Rupture2
- Burst Container or Vessel1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
- Insufficient Information1
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 11, 2021Burst Container or Vessel; Material Rupture; Burst Container or Vessel; Material Rupture
WHILE PHYSICIAN PERFORMING THE FISTULOGRAM PROCEDURE, THE BALLOON BURST OCCURRED BEFORE REACHING THE BURST RATE, ACCORDING TO THE RATE STATED ON THE PACKAGING.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 11464545 ↗MalfunctionDec 20, 2018Material Rupture
CUSTOMER REPORTED A BALLOON RUPTURE AT 16 ATM. NO PATIENT INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions; No Known Impact Or Consequence To Patient
MAUDE report 8183747 ↗
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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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