Phoenix 1.8mm x 149cm 5F Atherectomy System P18149KRecalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00845225002725), received between Feb 4, 2025 and Aug 3, 2026 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Entrapment of Device” (5 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 18, 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.

• MalfunctionAug 3, 2026Entrapment of Device

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50124397 ↗
• MalfunctionApr 13, 2026Entrapment of Device

  IT WAS REPORTED THAT A PHOENIX ATHERECTOMY CATHETER WAS USED FOR A THERAPEUTIC PERIPHERAL PROCEDURE IN A CTO AT THE DISTAL POPLITEAL. DURING USE, THE CATHETER WAS ADVANCED OVER A PHOENIX GUIDEWIRE TO THE SITE OF THE OCCLUSION, WHICH PERFORMED WELL BY FULLY REOPENING THE VESSEL. HOWEVER, AT THE DISTAL END OF THE OCCLUSION, THE GUIDEWIRE ROTATED DESPITE BEING SECURED TO THE TORQUER, AND THE CATHETER DRILL HEAD BORED INTO THE GUIDEWIRE AND BECAME JAMMED; THEREFORE, REMOVED AS A SYSTEM. UPON REMOVAL, IT WAS NOTED THAT A SMALL PIECE OF THE GUIDEWIRE HAD SEPARATED (MDR 9681477-2026-00052); UNABLE TO RETRIEVE DUE TO THE AREA NOT BEING ACCESSIBLE AND WAS NOT RELEVANT TO THE FOOT'S BLOOD SUPPLY. THE PROCEDURE WAS COMPLETED WITH A DRUG COATED BALLOON WITH NO PATIENT INJURY REPORTED. 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 24865586 ↗
• MalfunctionNov 12, 2025Entrapment of Device; Entrapment of Device

  IT WAS REPORTED THAT A PHOENIX CATHETER WAS USED IN A MODERATELY CALCIFIED PERIPHERAL PROCEDURE. PRIOR TO USING THE CATHETER IN THE PERONEAL, IVUS WAS PERFORMED IN THE POSTERIOR TIBIAL WHERE IT WAS NOTICED THAT AN UNDERSIZED STENT WAS IN THE VESSEL, THUS DECIDED NOT TO USE THE CATHETER IN THAT AREA. THE PHOENIX CATHETER WAS TURNED ON IN WHAT WAS THOUGHT TO BE THE PERONEAL, BUT WAS MISTAKENLY IN THE TIBIAL PERONEAL TRUNK, WHEN A WEIRD SOUND WAS NOTED. THE BATTERY PACK WAS FLIPPED BUT NOTHING WAS HAPPENING. THE CATHETER WAS REMOVED OVER THE GUIDEWIRE, BUT THE CATHETER CLIPPED THE END OF THE STENT AND PULLED IT OUT. NO STENT REPLACEMENT WAS NEEDED SINCE THE VESSEL LOOKED GOOD. THE PROCEDURE WAS COMPLETED WITH A NEW CATHETER WITH NO PATIENT INJURY REPORTED. THIS PRODUCT PROBLEM IS BEING SUBMITTED BECAUSE THE PHOENIX CATHETER AND EXISTING STENT WERE REMOVED AS A SYSTEM, POTENTIAL FOR HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23536286 ↗
• MalfunctionAug 15, 2025Entrapment of Device; Entrapment of Device

  IT WAS REPORTED THAT A PHOENIX CATHETER WAS USED IN A THERAPEUTIC PERIPHERAL PROCEDURE IN A SLIGHTLY CALCIFIED PROXIMAL SFA. DURING REMOVAL, THE CATHETER GOT STUCK ON A NON-PHILIPS GUIDEWIRE, AND BOTH WERE REMOVED AS A SYSTEM. THE PROCEDURE WAS COMPLETED WITH AN ANGIOPLASTY BALLOON WITH NO PATIENT INJURY REPORTED. THIS PRODUCT PROBLEM IS BEING SUBMITTED BECAUSE THE PHOENIX CATHETER AND CONCOMITANT DEVICE WERE REMOVED AS A SYSTEM; POTENTIAL FOR HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22821705 ↗
• MalfunctionFeb 4, 2025Entrapment of Device; Entrapment of Device

  IT WAS REPORTED THAT A PHOENIX CATHETER WAS USED IN A THERAPEUTIC PERIPHERAL PROCEDURE. DURING REMOVAL, THE CATHETER GOT STUCK ON A NON-PHILIPS GUIDEWIRE, AND BOTH WERE REMOVED AS A SYSTEM. THE PROCEDURE WAS COMPLETED WITH THE PHOENIX CATHETER. NO PATIENT INJURY REPORTED. THIS PRODUCT PROBLEM IS BEING SUBMITTED BECAUSE THE PHOENIX CATHETER AND A NON-PHILIPS 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 21305404 ↗