Surpass Evolve FDS50020Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 07613327375299), received between Sep 10, 2021 and Dec 4, 2024 — classified as 2 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Premature Activation” (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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 4, 2024Premature Activation; Premature Activation

  IT WAS REPORTED THAT DURING THE PROCEDURE, AFTER THE THIRD RE-SHEATH THE SUBJECT STENT CAME OFF THE RE-SHEATH PAD PREMATURELY. THE PHYSICIAN DEPLOYED THE SUBJECT STENT IN THE MICROCATHETER BEFORE REMOVING BOTH DEVICES FROM THE PATIENT. NO CLINICAL CONSEQUENCES WERE REPORTED TO THE PATIENT DUE TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20844931 ↗
• InjuryOct 26, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT POST PROCEDURE WITH THE SUBJECT FLOW DIVERTER PATIENT EXPERIENCED 2 EPISODES OF LOSS OF VISION IN LEFT EYE THAT LASTED LESS THAN 15 MIN EACH SINCE (B)(6) 2023. PRESENTED TO HIS LOCAL EMERGENCY ROOM. CT (COMPUTERIZED TOMOGRAPHY) HEAD, CTA (COMPUTED TOMOGRAPHY ANGIOGRAPHY) HEAD AND MRI- (MAGNETIC RESONANCE IMAGING) HEAD, ALL WERE NOTED TO BE NORMAL. OPHTHALMOLOGY CONSULT RULED OUT CENTRAL RETINAL ARTERY OCCLUSION. SUBJECT ADMITTED TO HOSPITAL OVERNIGHT FOR OBSERVATION. PATIENT IS PUT ON MEDICATIONS ASPIRIN INCREASED TO 325MG AND RESTARTED ON PLAVIX 75 MG FOR 21 DAYS, STARTED FROM 10/3/2023. INVESTIGATOR PLANS FOR DSA (DIGITAL SUBTRACTION ANGIOGRAPHY) AS SOON AS POSSIBLE. IT IS REPORTED THAT THE SUBJECT FLOW DIVERTER COULD HAVE RESULTED IN TIA (TRANSIENT ISCHEMIC ATTACK) CAUSING LOSS OF VISION IN LEFT EYE. THE REPORTED ADVERSE EVENT OUTCOME IS INDICATED AS NOT RECOVERED/NOT RESOLVED. IT IS REPORTED THAT THE ADVERSE EVENT IS POSSIBLY RELATED TO THE STUDY DEVICE AND AN UNDERLYING CONDITION OR DISEASE. THE RATIONALE FOR RELATIONSHIP TO THE STUDY DEVICE WAS STATED AS "DEVICE COULD HAVE RESULTED IN TIA CAUSING LOSS OF VISION IN LEFT EYE".

  Patient problems: Loss of Vision; Transient Ischemic Attack

  MAUDE report 18016425 ↗
• InjuryMar 1, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED IN A CLINICAL TRIAL THAT A PROCEDURE WAS DONE TO TREAT A RIGHT INTERNAL CAROTID ARTERY-OPHTHALMIC (C6 SEGMENT) INTRACRANIAL ANEURYSM WITH FLOW DIVERSION. THE PROCEDURE WAS COMPLETED WITH SUCCESSFUL IMPLANTATION OF THE SUBJECT FLOW DIVERTER AND COMPLETE COVERAGE OF THE TARGET ANEURYSM WITH NO DEVICE DEFICIENCIES NOTED. THE NEXT DAY POST PROCEDURE, THE PATIENT HAD SOME EXPRESSIVE APHASIA. THIS WAS REPORTED TO BE RESOLVING SPONTANEOUSLY BUT CAUSED THE PATIENT FRUSTRATION AND ANXIETY. THIS EVENT WAS REPORTED BY THE SITE AS RELATED TO THE SUBJECT FLOW DIVERTER, CATHETER, GUIDE WIRE, MICRO CATHETER AND BALLOON CATHETER.

  Patient problems: Dysphasia; Syncope/Fainting

  MAUDE report 13641328 ↗
• MalfunctionSep 10, 2021Premature Activation; Premature Activation

  IT WAS REPORTED DURING THE PROCEDURE THAT THE SUBJECT STENT PREMATURELY DEPLOYED WHILE ATTEMPTING TO RE-SHEATH. THE PHYSICIAN REPLACED IT WITH A NEW DEVICE AND COMPLETED THE PROCEDURE WITHOUT CLINICAL CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12457336 ↗