Prodigy™ Catheter PRODIGY8FRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00850032079143), received between Dec 19, 2025 and Dec 24, 2025 — classified as 2 injuries.

The most frequently reported specific device problem is “Break” (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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryDec 24, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE SUPERFICIAL FEMORAL ARTERY (SFA) WAS TREATED USING A THIRD-PARTY SHEATH, 8F PRODIGY CATHETER, AND 8F PRODIGY TWIST. THE CLOT WAS ORGANIZED. A VESSEL DISSECTION WAS DIAGNOSED, WHICH THE PHYSICIAN WAS UNAWARE OF UNTIL THE INITIAL ANGIOGRAM. THE DISSECTION IMPEDED BLOOD FLOW TO THE FOOT. IT WAS DETERMINED THAT THE DISSECTION WAS THE PRIMARY REASON FOR THE LACK OF FLOW AND WAS UNRELATED TO THE CATHETER'S ABILITY TO REMOVE CLOT. IT IS UNKNOWN WHETHER ANY ADDITIONAL INTERVENTION WAS PERFORMED TO ADDRESS THE DISSECTION. THERE WAS NO MALFUNCTION REPORTED DURING THE PROCEDURE.

  Patient problems: Vascular Dissection

  MAUDE report 23889460 ↗
• InjuryDec 19, 2025Break; Material Separation; Detachment of Device or Device Component; Break; Material Separation; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING AN IN-STENT RESTENOSIS (ISR) PROCEDURE, THE PRODIGY 8F CATHETER WAS USED WITH A THIRD-PARTY SHEATH AND GUIDEWIRE. AFTER THE SECOND PASS, THE PHYSICIAN NOTICED THE DISTAL TIP WAS MISSING. UPON FLUOROSCOPY, THE MARKER BAND WAS VISIBLE INSIDE THE STENT IN THE SFA. THE PHYSICIAN SUCCESSFULLY RETRIEVED THE MARKER BAND WITH THE USE OF AN ADDITIONAL THIRD-PARTY DEVICE. THERE WERE NO DEVICE MALFUNCTIONS OR DIFFICULTY TRACKING THE DEVICE DURING THE PROCEDURE. THE PATIENT WAS STABLE POST PROCEDURE, AND NO PATIENT SEQUELAE WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23854634 ↗