Surpass Streamline M003SFD030200Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 07613252648772), received between Sep 11, 2019 and Sep 11, 2019 — classified as 2 injuries.

The most frequently reported specific device problem is “Premature Separation” (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. 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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjurySep 11, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING THE PROCEDURE, IT WAS REPORTED THAT THE FLOW DIVERTER WAS INSERTED INTO THE CATHETER TO REACH THE TARGET LESION, BUT THE FLOW DIVERTER COULD NOT BE DEPLOYED DUE TO THE TORTUOSITY IN ICA (INTERNAL CAROTID ARTERY). SO THE DEVICE WAS REMOVED BUT THE DEVICE WAS PREMATURELY DEPLOYED IN THE CATHETER DURING REMOVAL. THEREFORE, THE PHYSICIAN RETRIEVED BOTH THE FLOW DIVERTER AND CATHETER TOGETHER. THEN THE SECOND ATTEMPT WAS MADE WITH A NEW FLOW DIVERTER (SUBJECT DEVICE) AND A NEW CATHETER, AND IT WAS SUCCESSFUL. POST BALLOON ANGIOPLASTY WAS PERFORMED WITH BALLOON CATHETER, AND THE PATIENT WOKE UP FINE. HOWEVER, THE SAME DAY AFTER THE PROCEDURE, THE PATIENT EXPERIENCED RIGHT SIDED WEAKNESS PRIOR TO DISCHARGE. UPON SCAN, IT WAS DETERMINED THAT THE PATIENT HAD EXPERIENCED MULTIPLE SMALL STROKES AND WAS NOT DOING WELL. HENCE, THE PATIENT HAD TO STAY IN THE HOSPITAL FOR MONITORING LONGER THAN ANTICIPATED DUE TO SYMPTOMS. THE PATIENT IS DISCHARGED NOW WITH SOME SYMPTOMS MAINTAIN. IN THE PHYSICIAN¿S OPINION, THE PATIENT¿S POST PROCEDURE COMPLICATION WAS CAUSALLY RELATED TO THE VESSEL MANIPULATION, AND THE VESSEL MANIPULATION WAS DUE TO THE NEED FOR REMOVAL OF THE SYSTEM (FLOW DIVERTER AND

  Patient problems: Neurological Deficit/Dysfunction; Stroke/CVA

  MAUDE report 9000724 ↗
• InjurySep 11, 2019Premature Separation; Premature Separation

  DURING THE PROCEDURE, IT WAS REPORTED THAT THE FLOW DIVERTER (SUBJECT DEVICE) WAS INSERTED INTO THE CATHETER TO REACH THE TARGET LESION, BUT THE FLOW DIVERTER COULD NOT BE DEPLOYED DUE TO THE TORTUOSITY IN ICA (INTERNAL CAROTID ARTERY). SO THE DEVICE WAS REMOVED BUT THE DEVICE WAS PREMATURELY DEPLOYED IN THE CATHETER DURING REMOVAL. THEREFORE, THE PHYSICIAN RETRIEVED BOTH THE FLOW DIVERTER AND CATHETER TOGETHER. THEN THE SECOND ATTEMPT WAS MADE WITH A NEW FLOW DIVERTER AND A NEW CATHETER, AND IT WAS SUCCESSFUL. POST BALLOON ANGIOPLASTY WAS PERFORMED WITH BALLOON CATHETER, AND THE PATIENT WOKE UP FINE. HOWEVER, THE SAME DAY AFTER THE PROCEDURE, THE PATIENT EXPERIENCED RIGHT SIDED WEAKNESS PRIOR TO DISCHARGE. UPON SCAN, IT WAS DETERMINED THAT THE PATIENT HAD EXPERIENCED MULTIPLE SMALL STROKES AND WAS NOT DOING WELL. HENCE, THE PATIENT HAD TO STAY IN THE HOSPITAL FOR MONITORING LONGER THAN ANTICIPATED DUE TO SYMPTOMS. THE PATIENT IS DISCHARGED NOW WITH SOME SYMPTOMS MAINTAIN. IN THE PHYSICIAN¿S OPINION, THE PATIENT¿S POST PROCEDURE COMPLICATION WAS CAUSALLY RELATED TO THE VESSEL MANIPULATION, AND THE VESSEL MANIPULATION WAS DUE TO THE NEED FOR REMOVAL OF THE SYSTEM (FLOW DIVERTER AND

  Patient problems: Neurological Deficit/Dysfunction; Stroke/CVA

  MAUDE report 8998367 ↗