Phoenix 1.5mm x 149cm 4F Atherectomy System P15149K (UDI 00845225003173)Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00845225003173), received between Oct 3, 2023 and Apr 28, 2026 — classified as 2 injuries, 1 malfunction.

The most frequently reported specific device problem is “Device Damaged by Another 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 28, 2026Device Damaged by Another Device

  IT WAS REPORTED THAT A PHOENIX CATHETER WAS USED FOR A PERIPHERAL PROCEDURE IN A SEVERELY CALCIFIED DISTAL DORSALIS PEDIS ARTERY (DPA). DURING THE SECOND INTRODUCTION OF THE CATHETER, IT WOULD NOT MOVE SMOOTHLY OVER THE ABBOTT GUIDEWIRE, POTENTIALLY DUE TO THE CALCIFICATION, REQUIRING MUCH FORCE TO GO OVER THE GUIDEWIRE. WHEN THE CATHETER AND GUIDEWIRE WAS BEING REMOVED, IT WAS NOTICED THAT THE GUIDEWIRE WAS SEEMINGLY CUT BY THE CATHETER, EVEN THOUGH THE DISTANCE BETWEEN THE TIPS OF THE CATHETER AND GUIDEWIRE WERE SUFFICIENT. ANGIO CONFIRMED NOTHING ELSE WAS RETAINED IN THE PATIENT, OTHER THAN THE GUIDEWIRE DISTAL TIP. THE PULSE IN THE PATIENT'S FOOT WAS MEASURED AND OBTAINED; PROCEDURE WAS COMPLETED. THIS ADVERSE EVENT IS BEING SUBMITTED CONSERVATIVELY BECAUSE THE PHOENIX CATHETER WAS BEING USED CONCOMITANTLY WHEN THE ABBOTT GUIDEWIRE SEPARATED; RETAINED IN PATIENT.

  Patient problems: Foreign Body In Patient

  MAUDE report 25023529 ↗
• InjuryMar 28, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PHOENIX CATHETER (1.5 MM) WAS USED IN A PERIPHERAL PROCEDURE. DURING USE, ANGIOGRAPHIC RUN SHOWED EXTRAVASATION OF CONTRAST, BUT IT IS UNKNOWN HOW THE PERFORATION WAS TREATED. FURTHER INFORMATION STATES THAT THE VESSEL MAY HAVE BEEN UNDERSIZED FOR THE SELECTED 1.5 MM PHOENIX CATHETER. THIS ADVERSE EVENT IS BEING SUBMITTED BECAUSE A PERFORATION OCCURRED, REQUIRING ADDITIONAL INTERVENTION. THERE WAS NO ALLEGED MALFUNCTION WITH THE PHOENIX CATHETER.

  Patient problems: Perforation of Vessels

  MAUDE report 21727069 ↗
• InjuryOct 3, 2023Material Separation; Material Separation

  IT WAS REPORTED THAT A PHOENIX ATHERECTOMY SYSTEM WAS USED IN A THERAPEUTIC PERIPHERAL PROCEDURE IN A MODERATELY CALCIFIED AND FIBROUS LESION. DURING REMOVAL, THE ROTATIONAL CUTTER HEAD SEPARATED FROM THE SHAFT WITHIN THE INTRODUCER SHEATH IN THE LEFT ILIAC ARTERY. A SNARE WAS USED TO RETRIEVE THE CUTTER HEAD, AND NO PATIENT INJURY REPORTED. THIS ADVERSE EVENT AND PRODUCT PROBLEM IS BEING SUBMITTED DUE TO THE CUTTER HEAD SEPARATION REQUIRING INTERVENTION (SNARE).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17865202 ↗