Phoenix 1.8mm x 130cm 5F Atherectomy Catheter P18130Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00845225002619), received between Apr 18, 2019 and Apr 28, 2021 — classified as 4 injuries, 1 malfunction.

The most frequently reported specific device problem is “Use of Device Problem” (2 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.

• InjuryApr 28, 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 FLUSHED WITH NORMAL PREPARATION. THE MANUFACTURER'S CATHETER WAS EASILY LOADED ON TO A V18 GUIDEWIRE INSIDE THE DISTAL LEFT ANTERIOR TIBIALIS WITH NO COMPLICATIONS. THEN, THE V18 GUIDEWIRE WAS CHANGED VIA A QUICKCROSS TO THE MANUFACTURER'S GUIDEWIRE. THE MANUFACTURER'S CATHETER WAS PLACED INTO THE PROXIMAL ANTERIOR TIBIALIS AND TREATED TWO SHORT LESIONS IN THE PROXIMAL PART WITH TWO PASSAGES. AT THE END OF THE SECOND LESION, THE MANUFACTURER'S CATHETER HAD A SLIGHT RESISTANCE AND WAS TAKEN BACK. FOLLOW-UP ANGIOGRAPHY IMAGES SHOWED A PERFORATION, WHICH WAS TREATED TWICE WITH A 3 MIN DILATATION WITH A 2MM/4 CM BALLOON AND A 3MM/8CM AMPHIRION. AFTER TREATMENT, THE PATIENT HAD GOOD RESULT. THIS ADVERSE EVENT IS BEING SUBMITTED BECAUSE THE PATIENT EXPERIENCED PERFORATION AND REQUIRED INTERVENTION.

  Patient problems: Perforation of Vessels

  MAUDE report 11742295 ↗
• InjuryApr 9, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED DURING A PLANNED THERAPEUTIC PERIPHERAL PROCEDURE, THE MANUFACTURERS DEVICE SUCCESSFULLY DEBULKED THE DESIRED LESION IN THE LEFT POSTERIOR TIBIAL (PT). THERE WAS RESISTANCE WHEN REMOVING THE DEVICE, BUT WAS REMOVED SUCCESSFULLY. AN .014 SLEEK BALLOON WAS ADVANCED TO THE SAME AREA AND WAS NOT ABLE TO CROSS THE WIRE AREA IN QUESTION. THE WIRE AND BALLOON WERE THEN REMOVED AS AN ASSEMBLY, THE WIRE REMAINED IN THE BALLOON. THE CASE WAS COMPLETED WITH PATIENT BALLOON ANGIOPLASTY, PATIENT IS REPORTEDLY IN "FINE" AND "POSITIVE" CONDITION. THIS ADVERSE EVENT IS BEING SUBMITTED SINCE THE MANUFACTURES DEVICE WAS USED WHEN THE PATIENT EXPERIENCED A VESSEL DISSECTION. THIS IS NOT BEING REPORTED AS A PRODUCT PROBLEM SINCE RECURRENCE OF THE MALFUNCTION WOULD NOT RESULT IN PATIENT HARM.

  Patient problems: Vascular Dissection

  MAUDE report 11642984 ↗
• InjuryNov 25, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS FOLLOW-UP SUPPLEMENTAL REPORT #2 IS BEING SUBMITTED TO ADVISE PERTINENT DEVICE ANALYSIS FINDINGS.

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

  MAUDE report 10901162 ↗
• InjuryJun 22, 2019Use of Device Problem; Use of Device Problem

  DURING A PLANNED THERAPEUTIC PERIPHERAL PROCEDURE, THE MANUFACTURE¿S CATHETER DEVICE BECAME DIFFICULT TO REMOVE OVER THE SUPPORT GUIDEWIRE. [PHYSICIAN] STEPPED ON FLUORO, TIP OF WIRE WAS DETACHED FROM SHAFT OF WIRE. THE DISTAL SHAFT OF WIRE WAS TWISTED ON ITSELF. A PORTION OF ANOTHER MANUFACTURE¿S GUIDEWIRE REMAINS IN THE PATIENT. THIS ADVERSE EVENT (AE) IS BEING SUBMITTED BECAUSE THE MANUFACTURE¿S DEVICE IS A CONCOMITANT DEVICE IN USE WHEN THE AE OF TIP SEPARATION FROM ANOTHER MANUFACTURE¿S DEVICE OCCURRED.

  Patient problems: Foreign Body In Patient

  MAUDE report 8725529 ↗
• MalfunctionApr 18, 2019Use of Device Problem; No Apparent Adverse Event; Use of Device Problem; No Apparent Adverse Event

  THIS FOLLOW-UP SUPPLEMENTAL REPORT #1 IS BEING SUBMITTED TO CORRECT INADVERTENT OMISSIONS AND TO CORRECT THE INITIAL REPORT SUBMISSION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8528425 ↗