First Choice EUHP75124Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 08570590020242), received between Jun 12, 2020 and Sep 12, 2025 — classified as 1 injury, 4 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

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 12, 2025Loss of or Failure to Bond; Loss of or Failure to Bond

  THE BALLOON CATHETER WAS USED FOR A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) PROCEDURE. THE SITE REPORTED THE BALLOON BROKE WHILE INSIDE THE PATIENT. THE PROVIDED IMAGE AND VIDEO CLIP CONFIRMED THE BALLOON CATHETER SEPARATED MID-BALLOON. THE DISTAL SEGMENT CONTAINED THE TIP, MARKER BAND, PART OF THE INNER LUMEN, AND PART OF THE BALLOON. NO SEGMENTS REMAINED IN THE PATIENT. THE PROCEDURE WAS COMPLETED WITH THE USE OF ANOTHER BALLOON. THERE WAS NO PATIENT INJURY. THE SITE WAS QUERIED FOR ADDITIONAL INFORMATION WITHOUT RECEIVING A RESPONSE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23045758 ↗
• InjuryOct 13, 2022Material Rupture; Material Separation; Material Rupture; Material Separation

  DURING A RIGHT UPPER ARM AV ANGIOPLASTY PROCEDURE, A PTA BALLOON BURST DURING INFLATION. THE PATIENT WAS BEING TREATED FOR CENTRAL AND BASILIC VEIN STENOSIS OF AN AV FISTULA. THE BALLOON BURST AT APPROXIMATELY 18ATM, WHICH WAS THE BURST RATE FOR THE DEVICE. THE BALLOON HAD BEEN INFLATED TWO (2) PREVIOUS TIMES PRIOR TO THE BURST AT 18 ATM. A 2MM PORTION OF THE BALLOON (INCLUDING DISTAL MARKER) DETACHED IN VIVO AND MIGRATED TO THE PATIENT'S RIGHT ATRIUM OF THE HEART. ATTEMPTS TO RETRIEVE THE FOREIGN BODY VIA VASCULAR SNARE DEVICE WERE UNSUCCESSFUL. THE PATIENT WAS TRANSFERRED TO ANOTHER HEALTHCARE FACILITY FOR AN ADDITIONAL RETRIEVAL ATTEMPT. THE ISSUE MAY RESULT IN SURGICAL REMOVAL OF THE FOREIGN BODY IF ALL ENDOVASCULAR ATTEMPTS FAIL. THE FOREIGN BODY HAD NOT MIGRATED ANY FURTHER AT THE MOMENT AND THE PATIENT REMAINED IN STABLE CONDITION.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 15598977 ↗
• MalfunctionDec 16, 2020Difficult to Insert; Mechanical Problem; Material Split, Cut or Torn; Separation Problem; Difficult to Insert; Mechanical Problem; Material Split, Cut or Torn; Separation Problem

  THE PHYSICIAN ATTEMPTED TO INSERT THE DEVICE INTO THE PATIENT, BUT THEY WERE NOT ABLE TO INSERT THE DEVICE INTO THE PATIENT. THE DEVICE WAS RIPPED DURING THIS PROCESS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11015427 ↗
• MalfunctionDec 15, 2020Inflation Problem; Material Puncture/Hole; Inflation Problem; Material Puncture/Hole

  THE 12 X 4 X 75 DIRECT ACCESS BALLOON WAS ATTEMPTED TO USE AND NOTICED A SMALL HOLE ON THE BALLOON AND WOULD NOT INFLATE TO ITS FULL POTENTIAL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11015293 ↗
• MalfunctionJun 12, 2020Material Rupture; Material Rupture

  ACCOUNT REPORTS BALLOON BROKE OFF WHILE IN PATIENT'S VENOUS SYSTEM IN SHOULDER. USER FACILITY COULD NOT SEE PIECE BROKEN OFF AND SENT PATIENT ACROSS STREET TO IU METHODIST HOSPITAL CT TO IDENTIFY WHERE PIECE WAS AND TREATED PATIENT AS NECESSARY. THE BALLOON INFLATED THE FIRST TIME TO FULL PRESSURE; IT BURST AT ABOUT 6-8 ATMOSPHERES ON THE SECOND INFLATION. THE FACILITY BELIEVES THE FRACTURED PIECE WAS LODGED IN THE STENT THAT WAS PLACED . THE FACILITY WAS GOING TO ATTEMPT TO SNARE OR CLIP THE PIECE OUT. SAME PATIENT, SAME BRACHIAL CEPHALIC STENT GRAFT BUT CAME IN FROM THE LEFT SIDE TODAY THROUGH THE IJ AND WAS IN A DIFFERENT LOCATION ON THE STENT - ESSENTIALLY THE OTHER END OF THE STENT. UPON ASKING FOR FURTHER INFORMATION IT BECAME EVIDENT THAT THEY STENT HAS BEEN IMPLANTED AND CAME IN TO CONTACT WITH THE METAL STENT AND THE CONTACT RUPTURED THE BALLOON.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 10148873 ↗