Phoenix 2.4mm 7F Deflecting Atherectomy Catheter PD24127Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00845225002633), received between May 18, 2018 and Feb 11, 2021 — classified as 3 injuries, 1 malfunction.

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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 11, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS CASE WAS REVIEWED AND INVESTIGATED ACCORDING TO THE MANUFACTURER¿S POLICY. IT WAS REPORTED DURING A THERAPEUTIC PERIPHERAL PROCEDURE, THE PHYSICIAN WAS PERFORMING AN ATHERECTOMY OF TWO LESIONS IN THE RIGHT SFA AND POPLITEAL. DURING THE SECOND PASSAGE OF THE DISTAL LESION THE HANDLE STOPPED TWICE. THE PHYSICIAN RECONNECTED THE HANDLE AND WE COULD PROCEED THE 2ND PASSAGE OF THE DISTAL POPLITEAL LESION. THE CONTROL ANGIOGRAPHY SHOWED THAN A DISSECTION IN THE POPLITEAL SEGMENT AND A LEAK OF CONTRAST MEDIA. THE PHYSICIAN DECIDED TO MAKE A PROLONGED DILATATION WITH ANOTHER MANUFACTURERS BALLOON DEVICE OVER 10 MINUTES WITH OUTSIDE PRESSURE FROM A BLOOD PRESSURE CUFF. CONTROL SHOWED A GOOD RESULT WITH NO LEAKS OF CONTRAST MEDIA. THE PHYSICIAN TREATED THE PROXIMAL LESION WITH AN ANOTHER MANUFACTURERS ANGIOPLASTY BALLOON. THE PHYSICIAN CHECKED THE LEG FROM PROXIMAL UP TO THE FOOT. IN CONSULTATION WITH THE VASCULAR SURGEON THE DECISION WAS TO KEEP IT WITHOUT STENTING. PATIENT WAS FINE ALL THE TIME, NO PAIN, NO ISSUES. THIS ADVERSE EVENT IS BEING SUBMITTED BECAUSE THE MANUFACTURES DEVICE WAS USED IN A PROCEDURE WHERE THE PATIENT EXPERIENCED A VESSEL DISSECTION.

  Patient problems: Vascular Dissection

  MAUDE report 11319780 ↗
• InjuryJan 12, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THERE IS NO ALLEGATION THE MANUFACTURERS DEVICE MALFUNCTIONED. IT WAS REPORTED DURING A PLANNED THERAPEUTIC PERIPHERAL PROCEDURE, THE MANUFACTURERS DEVICE SUCCESSFULLY DEBULKED THE DESIRED LESION. RESISTANCE WAS EXPERIENCED, THE MANUFACTURERS ATHERECTOMY DEVICE AND ANOTHER MANUFACTURERS GUIDEWIRE DEVICE WERE REMOVED TOGETHER. THE MANUFACTURERS DEVICE WAS DISCARDED. AFTER REMOVAL OF THE DEVICES X-RAY SHOWED THE TIP OF THE GUIDEWIRE REMAINED IN THE SUPERFICIAL FEMORAL ARTERY (SFA). THE TIP WAS REMOVED WITH A MICROSNARE. DURING TIP RETRIEVAL A DISTAL EMBOLIZATION OCCURRED AND WAS TREATED WITH AN ASPIRATION CATHETER AND NITROGLYCERIN. THE PATIENT WAS REPORTED AS "FINE" AT THE END OF THE PROCEDURE. FINAL ANGIOGRAPHY INDICATED THE LESION WAS WELL TREATED AND DISTAL BLOOD CIRCULATION WAS "FINE". LESION: CALCIFIED LESION FROM THE PROXIMAL SFA UP TO THE P2 SEGMENT. THIS ADVERSE EVENT IS BEING SUBMITTED BECAUSE THE MANUFACTURES DEVICE IS A CONCOMITANT DEVICE IN USE WHEN ANOTHER MANUFACTURES DEVICE SEPARATED IN A PATIENT. THERE IS NO ALLEGATION THE MANUFACTURERS DEVICE MALFUNCTIONED.

  Patient problems: Embolism; Muscle Spasm(s); Vessel Or Plaque, Device Embedded In

  MAUDE report 11155154 ↗
• InjuryNov 16, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS CASE WAS REVIEWED AND INVESTIGATED ACCORDING TO THE MANUFACTURER'S POLICY. IT WAS REPORTED THAT AFTER USING THE MANUFACTURER'S DEVICE TO SUCCESSFULLY TREAT AN IN STENT "RESTONOSIS" (ISR) OF 7/80 IN THE SUPERFICIAL FEMORAL ARTERY (SFA), ANGIOGRAPHY DISPLAYED A DELAY IN CONTRAST MEDIA THAT STOPPED BELOW THE STENT. CHANGING TO AN ASPIRATION CATHETER IT WAS OBSERVED THAT FRESH THROMBUS MATERIAL FLUSHED INTO AN EXTERNAL FILTER. AFTER BALLOONING THE ISR WITH A DRUG COATED BALLOON (DCB) THE VESSEL SHOWED A SMALLER DIAMETER BELOW THE STENT WHICH WAS TREATED WITH A SPASMOLYTICUM AND A PLAIN OLD BALLOON ANGIOPLASTY (POBA). THIS EVENT IS BEING REPORTED BECAUSE THE PATIENT EXPERIENCED AN EMBOLISM. IT COULD NOT CONCLUSIVELY BE DETERMINED IF THE MANUFACTURER'S DEVICE CAUSED OR CONTRIBUTED TO THE EVENT.

  Patient problems: Embolism

  MAUDE report 8081503 ↗
• MalfunctionMay 18, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS CASE WAS REVIEWED AND INVESTIGATED ACCORDING TO THE MANUFACTURER'S POLICY. IT WAS REPORTED, DURING A PERIPHERAL ATHERECTOMY PROCEDURE THE PHYSICIAN NOTICED THE GREEN MICROGLIDE COATING OF THE ABBOTT VASCULAR EXTRAS'PORT 0.014'' 300 CM GUIDEWIRE WAS DAMAGED BY THE BLADE OF THE MANUFACTURER'S DEVICE. THEY DECIDED TO STOP AND USE ANOTHER GUIDEWIRE AND THE ISSUE HAPPENED AGAIN. ANOTHER OF THE SAME MAKE AND MODEL OF THE MANUFACTURER'S DEVICE WAS USED TO CHECK IF THE PROBLEM WAS RELATED TO THE GUIDEWIRE OR THE MANUFACTURER'S DEVICE. NO HARM TO THE PATIENT AND THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE (PTA+DCB). BY REPORT, THE MANUFACTURERS DEVICE WAS INTACT AND IN ONE PIECE UPON REMOVAL WITH NO DAMAGE OBSERVED. DAMAGE WAS OBSERVED ON THE ABBOTT VASCULAR EXTRAS'PORT 0.014'' 300 CM GUIDEWIRE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WAS NO STATUS DECLINE, INJURY NOR ADDITIONAL INTERVENTION REQUIRED TO PREVENT INJURY. TO DATE THE DEVICE HAS NOT BEEN RETURNED TO THE MANUFACTURER FOR ANALYSIS. CONCOMITANT DEVICES: ABBOTT VASCULAR EXTRAS'PORT 0.014'' 300 CM REF: 22235M LOT 8013061, TERUMO DESTINATION 7F 45 CM . THE INSTRUCTIONS FOR USE (IFU) CAUTIONS: USE ONLY LISTED COMPATIB

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7526632 ↗