First Choice EUHP75164Recalls & reported problems
Creagh Medical Limited · Class 2
Data updated Oct 13, 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 08570590020235), received between Jun 20, 2023 and Jun 20, 2023 — classified as 1 injury.
The most frequently reported specific device problem is “Failure to Deflate” (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. How this data works · Data updated Oct 13, 2026.
Most reported problems
Device problems
- Failure to Deflate1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryJun 20, 2023Failure to Deflate; Failure to Deflate
DURING AN ANGIOPLASTY PROCEDURE, A BALLOON CATHETER WAS USED AND WOULD NOT DEFLATE. THE PATIENT WAS SENT TO THE HOSPITAL TO RESOLVE THE ISSUE. THE FISTULA WAS LOCATED IN THE PATIENT'S ARM IN THE SUBCLAVIAN VEIN. THE LEVEL OF VESSEL CALCIFICATION AND LESION LENGTH WERE UNKNOWN. THE DEGREE OF STENOSIS WAS APPROXIMATELY 50%. THE BALLOON WAS INFLATED TO 14PSI AND PREPPED PER IFU REQUIREMENTS. THE REPORTED ISSUE OCCURRED DURING INITIAL INFLATION. THE PATIENT WAS NOTED TO BE LARGER AND THE PHYSICIAN WAS UNABLE TO LOCATE THE EXACT AREA CONFIDENTLY WITH ULTRASOUND TO DEFLATE THE BALLOON. THE PHYSICIAN THOUGHT IT WOULD BE BETTER FOR THE PATIENT TO GET TO CARE WHERE THEY COULD RECEIVE A CT SCAN. THE BALLOON WAS RUPTURED AT THE HOSPITAL WITHOUT ISSUE AND THE PATIENT RECEIVED DIALYSIS VIA ACCESS. THE PATIENT WAS REPORTED TO BE DOING WELL. THE PATIENT THEN CAME BACK TO THE SITE ON (B)(6) 2023 FOR ADDITIONAL INTERVENTION ON THE ACCESS. THE SECOND PROCEDURE WAS COMPLETED WITHOUT ISSUE. THERE WAS NO FURTHER IMPACT TO THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17165762 ↗
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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 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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