Accunet 1011649-55Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 08717648085161), received between Oct 10, 2018 and Oct 10, 2018 — classified as 1 malfunction.

The most frequently reported specific device problem is “Device Damaged by Another Device” (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.

• MalfunctionOct 10, 2018Difficult to Remove; Device Damaged by Another Device; Difficult to Remove; Device Damaged by Another Device

  SUBSEQUENT TO THE FINAL REPORT, ADDITIONAL INFORMATION WAS RECEIVED. DURING REMOVAL OF THE ACCUNET FILTER ALONG WITH THE EMBOLIC PROTECTION SYSTEM (EPS), RESISTANCE WAS FELT WITH THE DEPLOYED 7-10 MM X 40 MM ACCULINK STENT. THEREFORE, A SERIES OF MANEUVERS WERE DONE WITH THE RECOVERY CATHETER AND THE PATIENT'S HEAD WAS MOVED; HOWEVER, IT WAS STILL NOT POSSIBLE TO RETRIEVE THE FILTER WITH THE EPS. IT WAS NOT EVEN POSSIBLE TO PUSH THE RECOVERY CATHETER UPWARDS AS THE UNIT WAS STUCK WITH THE STENT. THE RECOVERY CATHETER WAS THEN TUGGED AND THE FILTER WAS REMOVED FROM THE ANATOMY. HOWEVER, THE EPS ALSO MOVED THE ACCULINK STENT FROM THE LESION TO THE COMMON CAROTID ARTERY. AS STENT WAS THE APPROPRIATE SIZE FOR THE ARTERY AND REMAINED IN PLACE, NO FURTHER TREATMENT WAS PERFORMED. THE STENT APPEARED TO BE WELL APPOSED TO THE VESSEL. THE PATIENT IS STABLE AND HAD A FOLLOW-UP ON 10/25/2018. IT IS POSSIBLE THAT THE PATIENT WILL BE RE-HOSPITALIZED IN THE FUTURE AS THE LESION RESTENOSED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7952676 ↗