Phoenix 2.2mm x 149cm 6F Atherectomy Catheter P22149Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00845225002657), received between Sep 1, 2017 and Feb 24, 2023 — classified as 4 injuries, 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 24, 2023Sharp Edges; Sharp Edges

  IT WAS REPORTED THAT A PHOENIX CATHETER WAS USED IN A THERAPEUTIC PERIPHERAL PROCEDURE IN A MODERATELY CALCIFIED LESIONS. THE CATHETER WAS LOADED OVER A PHOENIX GUIDEWIRE, AND INSERTED THROUGH A NON-PHILIPS INTRODUCER SHEATH. THE PHOENIX CATHETER WAS TURNED ON, AND USED BACK AND FORTH IN MULTIPLE MIXED FOCAL LESIONS INTO THE SFA AND POPLITEAL ARTERY. AFTER THE 3RD PASS, THE BATTERY BEGAN TO DIE WITHIN 10 MINUTES. THE BATTERY WAS EXCHANGED, BUT THE DEVICE WOULD NOT TURN ON. THEREFORE, THE PHYSICIAN DECIDED TO REMOVE THE CATHETER SINCE THE PROCEDURE WAS ALMOST COMPLETED. DURING PULLBACK, RESISTANCE WAS ENCOUNTERED AND REQUIRED THE CATHETER TO BE MANIPULATED BACK AND FORTH. THE CATHETER FINALLY LOOSENED UP AND WAS ABLE TO BE REMOVED FROM THE PATIENT. UPON REMOVAL, A BROKEN SHAFT WAS NOTED EXPOSING THE INNER ARCHIMEDES SCREW. IVUS WAS PERFORMED AND CONFIRMED THE VESSELS WERE FINE, AND THE ATHERECTOMY WAS SUCCESSFUL. NO PATIENT INJURY REPORTED. DEVICE ANALYSIS CONFIRMED A BREAK AT THE OUTER LASER CUT SHAFT, WHICH HAS THE POTENTIAL TO HAVE A SHARP EDGE DUE TO THE MATERIAL BEING NON-MALLEABLE. THIS PRODUCT PROBLEM IS BEING SUBMITTED IN ABUNDANCE OF CAUTION, BECAUSE OF THE POTENTIALLY SHAR

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16438925 ↗
• MalfunctionNov 24, 2021Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  IT WAS REPORTED THAT DURING A THERAPEUTIC PERIPHERAL PROCEDURE AFTER TREATMENT, THE MANUFACTURER'S CATHETER WAS STUCK ON THE MANUFACTURER'S GUIDE WIRE AND WAS UNABLE TO BE REMOVED IN A PIN/PULL FASHION. DURING REMOVAL THE MANUFACTURER'S CATHETER WAS RUN BRIEFLY IN THE SHEATH TO TRACK BACKWARDS OFF THE MANUFACTURER'S GUIDE WIRE BUT REMAINED STUCK; THEREFORE, IT WAS REMOVED AS A SYSTEM. THE PROCEDURE WAS COMPLETED WITH A NON MANUFACTURER'S BALLOON WITH NO PATIENT INJURY REPORTED. DURING THE RETURN PRODUCT EVALUATION, FOREIGN PLASTIC MATERIAL FROM THE NON MANUFACTURER'S INTRODUCER SHEATH WAS OBSERVED ON THE CUTTER HEAD. 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 12872824 ↗
• InjuryMay 13, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING A PERIPHERAL PROCEDURE, THE MANUFACTURER'S CATHETER WAS ADVANCED TO THE PROXIMAL SFA TWICE WITH NO INCIDENT. UPON REMOVAL, X-RAY SHOWED THE DISTAL TIP OF THE MANUFACTURER'S GUIDE WIRE (APPROXIMATELY 10 INCHES LONG) BROKE OFF IN THE LOWER LEG OF THE PATIENT. A NON-MANUFACTURER'S WIRE WAS ADVANCED TO THE AREA AND A GOOSENECK SNARE WAS USED TO RETRIEVE THE PORTION OF THE MANUFACTURER'S GUIDE WIRE. FOLLOW-UP X-RAY CONFIRMED THAT NO PIECE OF THE MANUFACTURER'S GUIDE WIRE WAS RETAINED IN THE PATIENT. THE PATIENT WAS DISCHARGED AND DOING WELL. THIS ADVERSE EVENT IS BEING SUBMITTED BECAUSE THE MANUFACTURER'S CATHETER IS A CONCOMITANT DEVICE IN USE WHEN THE MANUFACTURER'S GUIDE WIRE SEPARATED IN THE PATIENT AND REQUIRED INTERVENTION. THERE IS NO ALLEGATION THE MANUFACTURER¿S CATHETER MALFUNCTIONED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11817171 ↗
• InjuryJan 10, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THE PHYSICIAN USED THE MANUFACTURE'S DEVICE IN A 6F TERUMO CROSS OVER SHEET DESTINATION. AFTER 1 RUN WITH THE MANUFACTURE'S DEVICE, THE GUIDE WIRE WAS STUCKING IN THE CATHETER AND COULD NOT MOVE FOR- OR BACKWARDS. PHYSICIAN MOVED THE COMPLETE SYSTEM [CATHETER AND GUIDEWIRE] BACK TO THE SHEET AND SAW THAT THE GUIDE WIRE WAS BROKEN [SEPARATED] AND LEFT IN A SMALL DISTAL VESSEL OF THE BTK [BELOW THE KNEE] AREA. PHYSICIAN LEAVE THE TIP IN THE VESSEL OF THE PATIENT. PATIENT DISCHARGED AS EXPECTED. CONDITION DESCRIBED AS "WELL." LESION: MID OF SFA AND MUCH MORE CALCIFIED IN P1 SEGMENT POPLITEA; SUBTOTAL OCCLUSION OF FSA AND PART OF POPLITEAL. TORTUOSITY: MODERATE THIS REPORT IS BEING SUBMITTED BECAUSE AN ADVERSE EVENT OF TIP SEPARATION OF ANOTHER MANUFACTURER'S WIRE DEVICE OCCURRED WHILE THE MANUFACTURE'S CATHETER DEVICE WAS IN USE.

  Patient problems: Embolism

  MAUDE report 8234297 ↗
• InjuryJul 27, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS CASE WAS INVESTIGATED ACCORDING TO THE MANUFACTURER'S POLICY. IT WAS REPORTED, THE MANUFACTURER'S DEVICE CAUSED THE GUIDEWIRE (ANOTHER MANUFACTURER'S DEVICE) TO BREAK INSIDE THE PATIENT. THE GUIDEWIRE BROKE AT THE DISTAL END. THE GUIDEWIRE WAS LEFT BEHIND INSIDE THE PATIENT. A SECOND DEVICE (ANOTHER MANUFACTURER'S DEVICE) WAS USED TO COMPLETE THE PROCEDURE. THE PATIENT WAS REPORTEDLY RELEASED IN "GOOD" CONDITION. OTHER DEVICES IN USE: COOK .014 300 CM ROADRUNNER. VESSEL: SUPERFICIAL FEMORAL ARTERY (SFA). THIS EVENT IS BEING REPORTED BECAUSE A PORTION OF THE GUIDEWIRE (ANOTHER MANUFACTURER'S DEVICE) SEPARATED IN THE PATIENT WHILE THE MANUFACTURER'S DEVICE WAS IN USE. THE SEPARATED PORTION OF THE GUIDEWIRE REMAINS IN THE PATIENT.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 7729259 ↗
• InjurySep 1, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED FOR A THERAPEUTIC PERIPHERAL PROCEDURE THE USER PLUGGED IN ATHERECTOMY CATHETER DEVICE, FLUSHED, MADE ONE PASS THAT WAS FINE, AND CAME BACK TO MAKE THE SECOND PASS. THE ATHERECTOMY DEVICE ALMOST STOPPED. THE PHYSICIAN PULLED BACK SLIGHTLY AND GOT IT TO WORK. WHEN THEY TRIED TO ADVANCE, IT WAS LIKE THERE WAS A BLOCKAGE. THEY STOPPED, PULLED THE ATHERECTOMY DEVICE AND DID ANGIOGRAM AND SAW THE THERE WAS A SUBSTANCE ON THE WIRE. THEY THEN TRIED TO ADVANCE A BALLOON DOWN THE WIRE AND IT WOULD NOT GO. THEY TRIED ADVANCING IT [THE CATHETER] AGAIN BUT WAS UNABLE. WHEN THEY PULLED THE WIRE THEY SAW SOMETHING ON THE WIRE THAT HAD BEEN PREVENTING THE PASS. PATIENT EXPERIENCED AN EVENT OF PERFORATED ARTERY AT ANTERIOR TIBIAL. PATIENT WAS RELEASED AS EXPECTED IN STABLE CONDITION. ON (B)(6) 2017 THE MANUFACTURER'S REPRESENTATIVE REPORTED THE PATIENT WAS ADMITTED TO THE HOSPITAL POST-PROCEDURE. VESSEL: 99% OCCLUSION, LOCATED ANTERIOR TIBIAL, MODERATELY CALCIFIED THIS EVENT IS BEING REPORTED BECAUSE THERE WAS A PATIENT EVENT DURING THE PROCEDURE.

  Patient problems: Perforation of Vessels

  MAUDE report 6840266 ↗