First Choice UHP7574Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 08570590020051), received between Jul 11, 2023 and Apr 25, 2024 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Difficult to Advance” (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

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 25, 2024Fracture; Fracture

  ADDITIONAL INFORMATION RECEIVED FROM THE DISTRIBUTOR INDICATED THE TARGET VESSEL HAD NO CALCIFICATION WITH APPROXIMATELY 80% STENOSIS. THE LESION LENGTH WAS NOT PROVIDED. IT WAS CONFIRMED THE BALLOON RUPTURED DURING INITIAL INFLATION TO 14ATM INSIDE OF A STENT. THERE WAS NO PATIENT HARM. THE EVENT RESULTED IN A PROCEDURE DELAY OF APPROXIMATELY 5 MINUTES. NO FURTHER MEDICAL INTERVENTION WAS REQUIRED AND THE PATIENT WAS IN STABLE CONDITION. PATIENT INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19183197 ↗
• InjuryJul 11, 2023Difficult to Advance; Difficult to Advance

  THE DEVICE WAS USED DURING A FISTULOGRAM PROCEDURE. THE 0.035" HYDROPHILIC GUIDEWIRE WAS PLACED THROUGH A 6FR INTRODUCER SHEATH. THE SITE WAS ABLE TO TRAVERSE TWO LESIONS. HOWEVER, THERE WAS DIFFICULTY LOADING THE BALLOON ONTO THE GUIDEWIRE, DESPITE FLUSHING THE BALLOON SEVERAL TIMES AND MAKING SURE THE GUIDE WIRE WAS MOISTENED AS WELL. THE PHYSICIAN WAS ULTIMATELY ABLE TO LOAD THE BALLOON, BUT WAS ONLY ABLE TO ADVANCE A FEW CENTIMETERS AND THEN WOULD NO LONGER ADVANCE. THE BALLOON WAS REMOVED AND A SECOND BALLOON WAS USED. HOWEVER, THE SECOND BALLOON WOULD ALSO NOT ADVANCE ON THE GUIDEWIRE; ALSO REPORTED AS DEFECTIVE. THE SECOND BALLOON HAD ULTIMATELY FRAYED THE HYDROPHILIC COATING OF THE GUIDEWIRE. THE ISSUE RESULTED IN THE INABILITY OF LOADING ANYTHING ON THE GUIDEWIRE. THE SITE DID NOT HAVE A WIRE CUTTER, SO THE WIRE AND BALLOON WERE REMOVED AND THE SITE HAD TO START OVER. THE SITE WAS THEN UNABLE TO RE-CROSS THE LESIONS. THE PROCEDURE WAS ABORTED AND RESCHEDULED FOR THE HOSPITAL OPERATING ROOM WITH AN ANESTHESIOLOGIST. THERE WAS NO REPORTED PROCEDURE DELAY. THERE WAS NO FURTHER IMPACT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17298739 ↗