Phoenix 2.4mm x 130cm 7F Deflecting Atherectomy System PD24130KRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00845225003197), received between May 7, 2024 and Mar 27, 2025 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Entrapment of Device” (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 18, 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.

• MalfunctionMar 27, 2025Entrapment of Device; Entrapment of Device

  IT WAS REPORTED THAT A PHOENIX ATHERECTOMY CATHETER WAS USED IN A THERAPEUTIC PERIPHERAL PROCEDURE. THE PHOENIX CATHETER WAS DELIVERED OVER A 0.014" PHOENIX GUIDEWIRE WITH NO ISSUES. HOWEVER, DURING REMOVAL, THE CATHETER GOT STUCK ON THE GUIDEWIRE, AND BOTH WERE REMOVED AS A SYSTEM. VISIBLE UNDER FLUOROSCOPY, THE TIP OF THE GUIDEWIRE (MDR 9681477-2025-00026) HAD SEPARATED AND WAS STENTED TO THE VESSEL WALL. SINCE THE ATHERECTOMY PROCEDURE WAS NOT SUFFICIENT AS EXPECTED DUE TO THE SEVERELY CALCIFIED LESION, THE PATIENT WAS BROUGHT BACK FIVE DAYS LATER FOR BYPASS. THIS PRODUCT PROBLEM IS BEING SUBMITTED BECAUSE THE PHOENIX CATHETER AND GUIDEWIRE WERE REMOVED AS A SYSTEM. THERE IS POTENTIAL FOR HARM IF IT WERE TO RECUR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21706870 ↗
• InjuryMay 7, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PHOENIX CATHETER WAS USED IN A THERAPEUTIC PERIPHERAL PROCEDURE IN A SEVERELY CALCIFIED LESION. FIRST, THE CATHETER WAS USED TO TREAT THE PROXIMAL SFA, AND DUE TO THE SEVERE CALCIFICATION, AN INOVA STENT WAS PLACED. NEXT, THE PLAN WAS TO TREAT THE DISTAL SEGMENT OF THE POPLITEAL ARTERY. BECAUSE OF THE HARD CALCIFICATION, A 3 MM BALLOON WAS PLACED OVER THE GUIDEWIRE FOR DILATATION. THEN, THE CATHETER WAS INSERTED OVER THE GUIDEWIRE TO TREAT THE POPLITEAL ARTERY. AFTER, THE GUIDEWIRE WAS REMOVED AND UNDER FLUOROSCOPY, CONTRAST MEDIUM LEAKAGE (EVIDENCE OF PERFORATION) WAS NOTED. AN ATTEMPT WAS MADE TO REPLACE WITH A 0.035 GUIDEWIRE DISTAL TO THE PERFORATION, BUT IMAGES SHOWED THE GUIDEWIRE HAD LOOPED, AND EXITED THE VESSEL, WORSENING THE PERFORATION. THEREFORE, IT WAS DECIDED TO BYPASS THE VESSEL WITH A VEIN. TODAY, THE PATIENT IS DOING FINE AND THE LEG IS WARM WITH GOOD PULSES. THIS ADVERSE EVENT IS BEING SUBMITTED BECAUSE THE PHOENIX CATHETER WAS IN THE AREA WHEN A PERFORATION OCCURRED, AND REQUIRED ADDITIONAL INTERVENTION. THERE WAS NO ALLEGED MALFUNCTION WITH THE PHOENIX CATHETER.

  Patient problems: Perforation of Vessels

  MAUDE report 19265696 ↗