Acculink™ 1011341-40Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 08717648076329), received between Feb 21, 2022 and Apr 28, 2026 — classified as 3 malfunctions.

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.

• MalfunctionApr 28, 2026Mechanical Jam; Activation Failure

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT THE CAROTID ARTERY WITH MILD CALCIFICATION AND MILD TORTUOSITY. THE ACCULINK SELF EXPANDING STENT SYSTEM (SESS) WAS ADVANCED TO THE LESION AND THE STENT WAS DEPLOYED ABOUT 1/10 WHEN THE HANDLE COULD NOT BE PUSHED. THE DEVICE WAS REMOVED AND ATTEMPTED TO RELEASE OUTSIDE THE ANATOMY WHICH WAS SUCCESSFUL. AN XACT SESS WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT EFFECTS. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25022228 ↗
• MalfunctionJan 28, 2026Improper or Incorrect Procedure or Method; Device Damaged by Another Device

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION IN THE INTERNAL CAROTID ARTERY WITH MODERATE CALCIFICATION AND HEAVY TORTUOSITY. THE EMBOSHIELD NAV 6 EMBOLIC PROTECTION SYSTEM WAS PREPARED PER INSTRUCTIONS FOR USE (IFU) AND DEPLOYED IN THE TARGET LESION. A BUDDY WIRE WAS PUT IN WITH THE NAV 6 AND SHOCKWAVE DEVICE WAS USED IN THE LESION. AN ACCULINK STENT WAS DEPLOYED WITHOUT ISSUES. AFTER REMOVAL OF THE ACCULINK DEVICE WITHOUT LIVE FLUOROSCOPY, X-RAY WAS PERFORMED AND THE FILTER WAS NOTED TO BE MISSING FROM THE BAREWIRE. THE FILTER WAS NOTED TO BE LODGED AT THE TIP OF THE ACCULINK DELIVERY SYSTEM OUTSIDE THE ANATOMY. THE BAREWIRE WAS SIMPLY REMOVED WITHOUT ISSUES AND THE PROCEDURE WAS COMPLETED. THERE WAS NO ADVERSE PATIENT EFFECT AND THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24201551 ↗
• MalfunctionFeb 21, 2022Mechanical Jam; Activation Failure; Mechanical Jam; Activation Failure

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION IN THE INTERNAL CAROTID ARTERY. A 9X40MM ACCULINK SELF-EXPANDING STENT SYSTEM (SESS) WAS ADVANCED TO THE TARGET LESION, AND THE LOCKING MECHANISM UNLOCKED; HOWEVER, THE HANDLE WOULD NOT RETRACT TO DEPLOY THE STENT. THE HANDLE WAS RETURNED TO THE ORIGINAL POSITION AND THE DEVICE REMOVED FROM THE ANATOMY. THERE WAS NO ADVERSE PATIENT EFFECT AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. A NON-ABBOTT DEVICE WAS USED TO COMPLETE THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13572978 ↗