First Choice EUHP75144Recalls & 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 08570590020228), received between May 26, 2021 and Sep 1, 2023 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Accessory Incompatible” (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
- Accessory Incompatible2
- Difficult to Open or Close2
- Failure to Deflate2
- Failure to Fold2
- Mechanical Jam2
- Fracture1
Patient problems
- No Clinical Signs, Symptoms or Conditions3
- Insufficient Information2
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 1, 2023Fracture; Fracture
DURING A LEFT ARM FISTULA ANGIOPLASTY PROCEDURE, THE BALLOON BURST WITHOUT MUCH PRESSURE BEING APPLIED. THE BALLOON BURST OCCURRED DURING INITIAL INFLATION. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH THE USE OF ANOTHER BALLOON. THERE WAS NO IMPACT TO PATIENT OUTCOME. THE PATIENT WAS DISCHARGED WITHOUT ISSUE. THERE WAS NO VISUAL CALCIFICATION AND THE LESION LENGTH WAS NOT MEASURED. THE VESSEL STENOSIS WAS ESTIMATED TO BE MODERATE. THE INFLATION PRESSURE WAS SAID TO BE LOW, BUT NOT QUANTIFIED BY THE SITE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17673736 ↗MalfunctionMay 26, 2021Accessory Incompatible; Failure to Fold; Difficult to Open or Close; Mechanical Jam; Failure to Deflate; Accessory Incompatible; Failure to Fold; Difficult to Open or Close; Mechanical Jam; Failure to Deflate
DURING PROCEDURE THE BALLOON DID NOT DEFLATE/ REFOLD CORRECTLY. THERE WAS DIFFICULTY IN RETRIEVAL AND GUIDE CATHETER TIP WAS DAMAGED. NO COMPLICATIONS OCCURED.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 11890705 ↗MalfunctionMay 26, 2021Accessory Incompatible; Failure to Fold; Difficult to Open or Close; Mechanical Jam; Failure to Deflate; Accessory Incompatible; Failure to Fold; Difficult to Open or Close; Mechanical Jam; Failure to Deflate
DURING PROCEDURE THE BALLOON DID NOT DEFLATE/ REFOLD CORRECTLY. THERE WAS DIFFICULTY IN RETRIEVAL AND GUIDE CATHETER TIP WAS DAMAGED. NO COMPLICATIONS OCCURED.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 11890703 ↗
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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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