Accunet 1011649-65Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 08717648085178), received between Aug 8, 2019 and Aug 8, 2019 — classified as 1 injury.

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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryAug 8, 2019Break; Difficult to Remove; Difficult to Advance; Break; Difficult to Remove; Difficult to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A LESION IN THE INTERNAL CAROTID ARTERY. AN ACCUNET EMBOLIC PROTECTION SYSTEM (EPS) WAS ADVANCED AND AN UNSPECIFIED STENT WAS SUCCESSFULLY DEPLOYED. AN ATTEMPT TO REMOVE THE FILTER OF THE EPS WITH THE RETRIEVAL CATHETERS 1 AND 2 WAS MADE; HOWEVER, THE FILTER WOULD NOT COLLAPSE INTO THE RETRIEVAL CATHETERS. ADDITIONAL TROUBLESHOOTING WAS PERFORMED WITHOUT SUCCESS. THE BUDDY GUIDE WIRE TECHNIQUE WAS USED IN ATTEMPT TO FACILITATE THE REMOVAL OF THE FILTER, BUT THE NON-ABBOTT GUIDE WIRE COULD NOT PASS THROUGH THE FILTER. THE GUIDE WIRE WAS REMOVED. A NON-ABBOTT EPS GUIDE WIRE, AN UNSPECIFIED BALLOON CATHETER, AND A GUIDELINER WERE USED IN ATTEMPT TO RETRIEVE THE FILTER, BUT WERE UNSUCCESSFUL. AT THIS POINT, THERE WERE CONCERNS THE FILTER WAS FULL; THEREFORE, AN EMBOSHIELD NAV6 EPS RETRIEVAL CATHETER WAS ADVANCED AND WAS ABLE TO RETRIEVE THE FILTER SUCCESSFULLY. OUTSIDE THE PATIENT IT WAS NOTED THAT THE FILTER WAS NOT FULL, BUT ONE OF THE STRUTS WAS BROKEN. THERE WAS NO ADVERSE PATIENT SEQUELA AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8876085 ↗