Phoenix 2.2mm x 130cm 6F Atherectomy Catheter P22130Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00845225002626), received between Feb 3, 2017 and Nov 10, 2021 — classified as 1 injury, 2 malfunctions.

The most frequently reported specific device problem is “Improper or Incorrect Procedure or Method” (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.

• MalfunctionNov 10, 2021Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  IT WAS REPORTED THAT DURING A THERAPEUTIC PERIPHERAL PROCEDURE IN A SLIGHTLY CALCIFIED SFA, THE MANUFACTURER'S CATHETER BECAME STUCK ON THE NON MANUFACTURER'S GUIDEWIRE. DURING REMOVAL THE MANUFACTURER'S CATHETER WAS RUN FOR A MOMENT INSIDE THE SHEATH BUT UNABLE TO RELEASE; THEREFORE, IT WAS REMOVED AS A SYSTEM. THE PROCEDURE WAS COMPLETED WITH A NEW SHEATH AND A NEW MANUFACTURER'S CATHETER. DURING THE RETURN PRODUCT EVALUATION, FOREIGN PLASTIC MATERIAL FROM THE NON MANUFACTURER'S SHEATH WAS OBSERVED ON THE CUTTER HEAD. NO PATIENT INJURY REPORTED. THIS PRODUCT PROBLEM IS BEING SUBMITTED AS CONCOMITANT USAGE DUE TO THE FOREIGN PLASTIC MATERIAL OBSERVED ON THE MANUFACTURER'S CATHETER. THERE IS POTENTIAL FOR HARM WITH RECURRENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12791780 ↗
• InjuryDec 29, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A COOK GUIDEWIRE WAS USED AND 2CM OF THE COOK SPRING TIP WAS BROKEN OFF INSIDE THE PATIENT [DURING A PERIPHERAL ATHERECTOMY PROCEDURE UTILIZING THE MANUFACTURERS ATHERECTOMY DEVICE.] THEY DID NOT RETRIEVE THE SPRING-TIP. THROUGH X-RAY THEY CONFIRMED IT WAS IN A SIDE BRANCH, NOT FLOW LIMITING. THEY WERE ABLE TO COMPLETE THE CASE. THE PATIENT'S TREATMENT WAS COMPLETED BY THIS PROCEDURE WITH THE PATIENT DISCHARGED AS EXPECTED. VESSEL: LESION LOCATION WAS THE ENTIRE ANTERIOR TIBIAL ARTERY; 80-100% OCCLUDED; PLAQUE APPEARED TO BE CALIFIC; NO TORTUOSITY NOTED EXCEPT FOR THE TYPICAL BEND IN PROXIMAL ANTERIOR TIBIAL (AS PER ANATOMY.) OTHER DEVICES IN USE: COOK ANSEL 90CM SHEATH, COOK ROADRUNNER .014X300CM GUIDEWIRE. THIS EVENT IS BEING REPORTED BECAUSE AN ADVERSE EVENT OCCURRED (COOK ANSEL GUIDEWIRE TIP SEPARATION) WHILE THE MANUFACTURERS DEVICE WAS IN USE AS PART OF THE PROCEDURE. THIS WAS NOT A MALFUNCTION OF THE MANUFACTURERS ATHERECTOMY DEVICE.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 7155719 ↗
• MalfunctionFeb 3, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS CASE HAS BEEN INVESTIGATED IN ACCORDANCE WITH THE MANUFACTURERS POLICY. IT WAS REPORTED THAT DURING THE PROCEDURE WHILE REMOVING THE MANUFACTURERS DEVICE, OVER THE COOK WIRE, THE TIP OF THE WIRE BROKE OFF IN AN OCCLUDED PERONEAL ARTERY. THE PHYSICIAN ELECTED NOT TO ATTEMPT INTERVENTION TO REMOVE THE WIRE FRAGMENT AS IT WAS IN AN OCCLUDED ARTERY WITH NO ADDITIONAL CLINICAL SEQUELA. THE PHYSICIAN PERFORMED AN ADJUNCTIVE PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) TO COMPLETE THE PROCEDURE. THE PATIENT'S TREATMENT WAS COMPLETED BY THIS PROCEDURE WITH THE PATIENT DISCHARGED AS EXPECTED. VESSEL: SFA/POP AND TPT. OTHER DEVICES IN USE: COOK ROADRUNNER LOT# 7405229.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 6302675 ↗