Prodigy Twist™ TWIST8FRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00850032079150), received between Apr 12, 2024 and Dec 24, 2025 — classified as 2 injuries.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (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 23889524 ↗
• InjuryApr 12, 2024Material Separation; Detachment of Device or Device Component; Material Separation; Detachment of Device or Device Component

  THE INTRAVASCULAR PROCEDURE BEGAN WITH CONTRALATERAL ACCESS WITH AN 8F PINNACLE SHEATH IN THE LEFT GROIN. A SERIES OF THIRD-PARTY CATHETERS, SHEATHS, AND WIRES WERE UTILIZED TO ACCESS THE GRAFT LOCATION WITH NO REPORTED CHALLENGES. ONCE ACCESS TO THE INTENDED LOCATION WAS OBTAINED, THE 8F PRODIGY CATHETER WAS USED TO COMPLETE THREE ASPIRATION PASSES WITH NO CLOT CAPTURE AND MINIMAL BLOOD LOSS. THE PRODIGY CATHETER WAS NOT LONG ENOUGH TO REACH THE DISTAL PORTION (INCLUDING THE DISTAL ANASTOMOSIS) OF THE GRAFT. TWO ADDITIONAL PASSES WERE COMPLETED WITH THE 8F PRODIGY TWIST BY ROTATING THE TWIST HANDLE CLOCKWISE WITH ONE HAND. ON THE FIRST PASS WITH THE TWIST, 7-10 CYCLES WERE CONDUCTED. THE MOVEMENT OF TWIST WAS MONITORED INTERMITTENTLY UNDER FLUOROSCOPY AND FELT SMOOTH TO THE PHYSICIAN WITH NO TACTILE VARIATION. ON THE SECOND PASS WITH TWIST, 3-5 CYCLES WERE CONDUCTED. SEPARATION OF TWIST TIP WAS NOTED WHEN DISTAL MARKERS ON THE TWIST TIP DID NOT MOVE AS ANTICIPATED UNDER FLUOROSCOPY. TWIST TIP WAS LOCATED BY FLUOROSCOPY IN THE GRAFT LUMEN . SEVERAL ATTEMPTS WERE MADE TO ASPIRATE SEPARATED TIP THROUGH THE CATHETER BUT UNSUCCESSFUL. A STENT WAS DEPLOYED IN THE GRAFT TO TRAP THE TWIST

  Patient problems: Obstruction/Occlusion; Stenosis

  MAUDE report 19099125 ↗