Acculink™ 1011344-30Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 08717648076381), received between Aug 21, 2018 and Apr 22, 2022 — classified as 1 injury, 3 malfunctions.

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

• MalfunctionApr 22, 2022Difficult or Delayed Activation; Physical Resistance/Sticking; Difficult or Delayed Activation; Physical Resistance/Sticking

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT THE RIGHT COMMON CAROTID ARTERY WITH MILD CALCIFICATION. A 7.0-10 X 30MM ACCULINK SELF EXPANDING STENT SYSTEM (SESS) WAS ADVANCED TO THE TARGET LESION. HOWEVER, AFTER UNLOCKING THE SESS, RESISTANCE WAS NOTED WHEN PULLING BACK THE HANDLE DURING DEPLOYMENT OF THE STENT. THE STENT WAS SUCCESSFULLY DEPLOYED WITHOUT FURTHER ISSUE. THERE WAS NO ADVERSE PATIENT EFFECT AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14190740 ↗
• InjuryJan 5, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A HEAVILY TORTUOUS, HEAVILY CALCIFIED RIGHT EXTERNAL COMMON CAROTID ARTERY. ON (B)(6) 2021, AN ACCULINK STENT WAS SUCCESSFULLY DEPLOYED. THE NEXT DAY, ON (B)(6) 2021, THE PATIENT SHOWED SIGNS OF HYPERPERFUSION (UNKNOWN IF BLOOD PRESSURE WAS TOO HIGH OR TOO LOW). THE PATIENT'S BLOOD PRESSURE WAS MEDICALLY MANAGED (PATIENT REMAINED UNDER OBSERVATION BUT CONDITION REMAINED RELATIVELY STABLE AND NO TREATMENT WAS PERFORMED). THEN ON (B)(6) 2021, IMAGING AND ULTRA SOUND SHOWED 70% OCCLUSION. THE SURGEON DECIDED TO SURGICALLY REMOVE THE STENT AND TREAT THE OCCLUSION VIA A CAROTID SURGICAL ENDARTERECTOMY INTERVENTION. HOSPITALIZATION WAS PROLONGED BUT PATIENT CONDITION WAS FINE AFTER SURGICAL PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Nervous System Injury; Obstruction/Occlusion

  MAUDE report 13172188 ↗
• MalfunctionJan 11, 2021Premature Activation; Ambient Temperature Problem; Premature Activation; Ambient Temperature Problem

  SUBSEQUENT TO THE INITIAL MEDWATCH REPORT, THE FOLLOWING INFORMATION WAS PROVIDED: IT WAS REPORTED THAT DURING PREPARATION, THE .014 ACCULINK SELF-EXPANDING STENT (SES) WAS REMOVED FROM THE PACKAGING, WHEN IT WAS NOTED THAT THE TEMPERATURE INDICATOR WAS FOUND TO BE BLACK. THE DEVICE WAS NOT USED. THERE WAS NO PATIENT INVOLVEMENT AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Patient Involvement

  MAUDE report 11152750 ↗
• MalfunctionAug 21, 2018Device Damaged by Another Device; Device Damaged by Another Device

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A MODERATELY TORTUOUS AND MILDLY CALCIFIED RIGHT CAROTID ARTERY. A 190 CM EMBOSHIELD NAV6 EMBOLIC PROTECTION SYSTEM (EPS) WAS USED ALONG WITH A 7-10 X 30 MM ACCULINK II SELF-EXPANDING STENT SYSTEM. THE DEVICES DID NOT MEET ANY RESISTANCE DURING ADVANCEMENT. THE STENT WAS IMPLANTED AND A 4.0 X 30 MM AND A 5.0 X 20 MM VIATRAC BALLOON DILATATION CATHETER WERE USED FOR PRE AND POST-DILATATION. HOWEVER, DURING AN ATTEMPT TO RETRIEVE THE FILTRATION ELEMENT, IT BECAME CAUGHT WITH THE DISTAL PART OF THE STENT AND THERE WERE SEVERAL UNSUCCESSFUL ATTEMPTS TO REMOVE THE FILTRATION ELEMENT. THEN, THE FILTRATION ELEMENT INADVERTENTLY EXPLANTED THE STENT AND BOTH DEVICES WERE INADVERTENTLY REMOVED AS A SINGLE UNIT. THE STENT COULD NOT BE LOCATED AND IT WAS NOT IN THE TRASH CAN. FLUOROSCOPY AND X-RAY WERE ALSO DONE; HOWEVER, THE STENT WAS NOT FOUND INSIDE THE ANATOMY EITHER. ADDITIONALLY, THE STENT WAS NOT FOUND IN THE GUIDE WIRE FILTER OF THE EMBOSHIELD NAV6 DEVICE. THEREFORE, ANOTHER UNSPECIFIED EMBOSHIELD NAV6 EPS AND AN ACCULINK STENT WERE USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. THERE WAS A CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE; HOW

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7801057 ↗