Surpass Evolve FDS50012Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 07613327386707), received between Jan 4, 2024 and Jan 13, 2025 — classified as 2 injuries, 1 malfunction.

The most frequently reported specific device problem is “Activation Failure” (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 16, 2026.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryJan 13, 2025Activation Failure; Migration; Activation Failure; Migration

  IT WAS REPORTED THAT DURING PROCEDURE DEPLOYMENT ATTEMPTS FOR TWO STENTS. THE SUBJECT STENT FAILED TO OPEN PROPERLY DUE TO SIGNIFICANT RESISTANCE CAUSED BY TORTUOSITY AND HIGH RIDING GENU. THE DISTAL SEGMENT OF THE STENT DID NOT OPPOSE WELL, AND THE MID-SEGMENT FAILED TO OPEN, LEADING TO PROXIMAL MIGRATION OF THE STENT. TO ADDRESS THIS, THE PHYSICIAN USED ADDITIONAL STENT TO TACK DOWN THE UNOPENED SECTION OF THE STENT, SUCCESSFULLY RESTORING NORMAL LUMEN AND COMPLETING THE PROCEDURE WITHOUT COMPLICATIONS. THE PATIENT WAS DISCHARGED THE NEXT DAY. RESISTANCE WAS ENCOUNTERED THROUGHOUT THE PROCEDURE, PRIMARILY DUE TO THE SEVERE TORTUOSITY IN THE ICA (INTERNAL CAROTID ARTERY) AND THE ARTERY SIZE (5MM).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21138612 ↗
• InjuryMar 29, 2024Activation Failure; Activation Failure

  IT WAS REPORTED THAT DURING A NEUROVASCULAR PROCEDURE, A SMALL LEDGE WAS NOTICED ON THE PROXIMAL END OF THE SUBJECT FLOW DIVERTER. THEREFORE AN ADDITIONAL STENT WAS DEPLOYED ON THE PROXIMAL END OF THE SUBJECT FLOW DIVERTER. IT WAS REPORTED THAT THE PATIENT WAS NOT HURT IN THE PROCESS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19008079 ↗
• MalfunctionJan 4, 2024Fracture; Fracture

  IT WAS REPORTED THAT DURING A LEFT INTERNAL CAROTID ARTERY (ICA) ANEURYSM CASE, SUBJECT STENT WAS DEPLOYED USING THE MICROCATHETER ACROSS PARAOPHTHALMIC REGION OF ANEURYSM. PHYSICIAN THEN TRIED TO RECAPTURE STENT DELIVERY WIRE (SDW) INTO THE MICROCATHETER BUT FELT RESISTANCE WHEN RECAPTURING IN THE AREA OF THE RE-SHEATH PAD SO PULLED THE MICROCATHETER AND SDW OUT OF THE PATIENT¿S BODY. IT WAS NOTED THAT THE RE-SHEATH PAD HAD BEEN PUSHED FORWARD OVER THE ¿POINT OF NO RETURN¿ MARKER ON THE DELIVERY WIRE CONFIRMING THE SDW COMPONENT FRACTURE. NO CLINICAL CONSEQUENCES WERE REPORTED TO THE PATIENT DUE TO THIS EVENT. THE PROCEDURE WAS COMPLETED SUCCESSFULLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18444276 ↗