AcculinkRecalls & reported problems across all models

We found 13 models of Acculink by Abbott Vascular Inc. in the FDA's device registry (GUDID). Together they are named in 87 adverse event reports in the FDA's MAUDE database, received between Aug 22, 2016 and Jul 30, 2026 — classified as 17 injuries, 70 malfunctions.

The most frequently reported specific device problem is “Activation Failure” (32 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Most reported Acculink problems

Acculink models

13 models, most reported first. Each model has its own page with its reports, recalls and device details.

• Acculink™ 1011344-40

  STENT, CAROTID
  32 reports
• Acculink™ 1011343-40

  STENT, CAROTID
  31 reports
• Acculink™ 1011343-30

  STENT, CAROTID
  5 reports
• Acculink™ 1011344-30

  STENT, CAROTID
  4 reports
• Acculink™ 1011341-40

  STENT, CAROTID
  3 reports
• Acculink™ 1011338-30

  STENT, CAROTID
  2 reports
• Acculink™ 1011339-40

  STENT, CAROTID
  2 reports
• Acculink™ 1011340-40

  STENT, CAROTID
  2 reports
• Acculink™ 1011342-30

  STENT, CAROTID
  2 reports
• Acculink™ 1011337-30

  STENT, CAROTID
  1 report
• Acculink™ 1011338-40

  STENT, CAROTID
  1 report
• Acculink™ 1011340-30

  STENT, CAROTID
  1 report
• Acculink™ 1011342-20

  STENT, CAROTID
  1 report

Recent Acculink adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

• MalfunctionJul 30, 2026Mechanical Jam; Activation Failure

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50089981 ↗
• MalfunctionJul 28, 2026Activation Failure

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50052762 ↗
• MalfunctionJul 14, 2026Mechanical Jam; Activation Failure

  IT WAS REPORTED THIS WAS A PROCEDURE TO TREAT A MILDLY CALCIFIED, MILDLY TORTUOUS, AND 90% STENOSED INTERNAL CAROTID ARTERY. AN ACCULINK 6-8/40 WAS INSERTED BUT FAILED AS THE STENT PARTIALLY DEPLOYED AS THERE WAS MECHANICAL ISSUE WITH THE THUMBSLIDE. THE STENT WAS REMOVED AND REPLACED WITH AN ACCULINK 8/40. HOWEVER, THE SAME FAILURE TO DEPLOY TO BE DEPLOY OCCURRED. THE STENT WAS REMOVED AND REPLACED WITH A DIFFERENT SIZE ACCULINK WAS INSERTED AND SUCCESSFULLY DEPLOYED. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25815436 ↗
• MalfunctionJul 6, 2026Activation Failure

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A DE NOVO LESION IN THE INTERNAL CAROTID ARTERY WITH MILD CALCIFICATION, MILD TORTUOSITY AND 94% STENOSIS. THE ACCULINK SELF EXPANDING STENT SYSTEM (SESS) WAS ADVANCED TO THE LESION BUT THE STENT COULD NOT BE DEPLOYED. THERE WAS NO PROBLEM WITH THE DEPLOYMENT MECHANISM. ANOTHER SAME SIZE DEVICE 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 25718475 ↗
• MalfunctionJun 3, 2026Material Separation; Difficult to Advance; Activation Failure

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A DE NOVO LESION IN THE INTERNAL CAROTID ARTERY WITH MILD CALCIFICATION, HEAVY TORTUOSITY AND 80% STENOSIS. THE ACCULINK SELF EXPANDING STENT SYSTEM (SESS) WAS ADVANCED TO THE LESION AND THE HANDLE WAS PULLED BACK; HOWEVER, THE STENT ONLY PARTIALLY DEPLOYED. THERE WERE NO ADVERSE PATIENT EFFECTS. A NEW ACCCULINK SESS WAS USED TO COMPLETE THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25374354 ↗
• MalfunctionMay 5, 2026Material Separation; Component Missing

  IT WAS REPORTED THAT PRIOR TO USE OF THE 6-8X40MM ACCULINK SELF-EXPANDING STENT SYSTEM (SESS), THE WHITE TIP [NOSE CONE] WAS NOTED TO BE MISSING. THEREFORE, THE SESS WAS NOT USED IN THE PROCEDURE. ANOTHER UNSPECIFIED STENT WAS USED TO CONTINUE THE PROCEDURE. THERE WAS NO PATIENT INVOLVEMENT AND NO CLINICALLY SIGNIFICANT DELAY REPORTED IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25084890 ↗
• MalfunctionMay 5, 2026Break; Difficult to Advance; Activation Failure

  IT WAS REPORTED THAT THE ACCULINK DEVICE MET RESISTANCE DURING ADVANCEMENT BUT WAS DELIVERED TO THE TARGET LESION IN THE MILDLY CALCIFIED/TORTUOUS INTERNAL CAROTID ARTERY. THERE WAS A FAILURE OF THE ACCULINK STENT TO DEPLOY AT THE TARGET. AFTER MULTIPLE ATTEMPTS, THE DEVICE WAS WITHDRAWN. THERE WAS NO FLOWERING, NOR PARTIAL STENT DEPLOYMENT; NO STENT EXPOSED. THE STENT REMAINED COMPLETELY WITHIN THE DEPLOYMENT SHEATH. A NEW ACCULINK DEVICE WAS USED, SUCCESSFULLY COMPLETING THE PROCEDURE. NO PATIENT CONSEQUENCE WAS REPORTED. THE SHAFT OF THE RETURNED DEVICE WAS SEPARATED AT THE DISTAL END OF THE HANDLE SLIDER. THE CUSTOMER WAS NOT AWARE OF THIS SEPARATION. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25083350 ↗
• 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 ↗
• MalfunctionMar 30, 2026Activation Failure

  IT WAS REPORTED THE PROCEDURE WAS TO TREAT A LESION IN THE CAROTID ARTERY. DURING PREPARATION OF THE NAV6 EMBOLIC PROTECTION SYSTEM (EPS), THE DISTAL END OF THE DELIVERY CATHETER WAS BENT, MAKING IT IMPOSSIBLE TO INSERT THE FILTER INTO THE DELIVERY CATHETER. A NEW NAV6 WAS USED WITHOUT ISSUE. THE 7-10/40 ACCULINK SELF EXPANDING STENT SYSTEM (SES) WAS ADVANCED TO THE TARGET LESION HOWEVER DURING DEPLOYMENT, THE HANDLE SLIDER WAS ADVANCED HOWEVER THE STENT FAILED TO DEPLOY. DEPLOYMENT WAS ATTEMPTED AGAIN HOWEVER NO STENT DEPLOYED. THE SES WAS REMOVED AND THE PROCEDURE COMPLETED USING A NEW ACCULINK. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED. RETURN DEVICE ANALYSIS NOTED THE STENT IMPLANT WAS PARTIALLY DEPLOYED (FLOWERED) 1.5 CENTIMETERS (CM) FROM THE DISTAL END OF THE SHEATH.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24713721 ↗
• MalfunctionFeb 20, 2026Break; Mechanical Jam; Activation Failure

  IT WAS REPORTED THAT THE PROCEDURE PERFORMED WAS TO TREAT AN INTERNAL CAROTID ARTERY. ONCE AT THE LESION, THE HANDLE SLIDE OF THE 6-8X40MM ACCULINK CAROTID SELF-EXPANDING STENT SYSTEM OVER A 0.14 GUIDEWIRE WAS PULLED; HOWEVER, THE STENT COMPLETELY FAILED TO DEPLOY. AN XACT CAROTID STENT WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. SUBSEQUENTLY, RETURNED DEVICE ANALYSIS OBSERVED THE SHAFT WAS SEPARATED AT THE DISTAL END OF THE HANDLE SLIDER. THE SHAFT AT THE SEPARATION WAS BUNCHED AND THE HYPOTUBE WAS STILL INTACT HOLDING BOTH PIECES TOGETHER. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24404130 ↗
• 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 ↗
• MalfunctionDec 19, 2025Mechanical Jam; Activation Failure; Mechanical Jam; Activation Failure

  FOR REPORTING PURPOSES, THE DATE OF EVENT/PROCEDURE IS ESTIMATED AS (B)(6) 2025, AS IT IS THE FIRST DATE OF THE MONTH OF THE AV ALERT DATE. IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT AN UNSPECIFIED LESION. PRE-DILATATION WAS PERFORMED WITH A 4.0 MM BALLOON. THE ACCULINK SELF EXPANDING STENT SYSTEM (SESS) WAS ADVANCED TO THE LESION AND DEPLOYMENT WAS ATTEMPTED. THE LEVER WAS STIFF BUT IT WAS THOUGHT THAT THE STENT WAS DEPLOYED. WHEN THE DELIVERY SYSTEM WAS REMOVED, THE STENT WAS UNABLE TO BE FOUND ON THE DELIVERY SYSTEM OR IN THE PATIENT. THE DEVICE WAS CUT OPEN AND THE STENT WAS FOUND INSIDE THE SYSTEM. ANOTHER SAME SIZE ACCULINK SESS WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT EFFECTS. THERE WAS A SMALL DELAY IN THE PROCEDURE BUT NO HARM TO THE PATIENT. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23851432 ↗
• MalfunctionDec 16, 2025Malposition of Device; Malposition of Device

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A LESION IN THE MODERATELY TO HEAVILY TORTUOUS AND HEAVILY CALCIFIED LESION IN THE LEFT CAROTID ARTERY. THE EMBOSHIELD NAV6 EMBOLIC PROTECTION SYSTEM (EBS) WAS ADVANCED; HOWEVER, RESISTANCE WITH THE ANATOMY WAS FELT. THE EBS LOST CANULATION WITH THE CATHETER AND THE VESSEL HAD TO BE RE-CANULATED. NEXT A 4.0X30MM VIATRAC PLUS BALLON CATHETER WAS ADVANCED AND THE LESION WAS DILATED WITHOUT ISSUES. A 10TX40X136MM XACT SELF EXPANDING STENT SYSTEM (SES) WAS BEING ADVANCED, BUT RESISTANCE WITH THE ANATOMY WAS FELT THEREFORE IT WAS REMOVED. A 7X10X40MM ACCULINK SES WAS ADVANCED WITHOUT ISSUES; HOWEVER, DURING DEPLOYMENT THE STENT JUMPED AND THE STENT DEPLOYED BUT MISSED ABOUT 20% OF THE LESION. THE PREVIOUSLY USED 10TX40X136MM XACT SES WAS ADVANCED AND DEPLOYED AT THE REST OF THE 20% OF THE LESION OVERLAPPING WITH THE ACCULINK STENT. AN ANGIOGRAM WAS PERFORMED AND FLOW WAS NOTED. WENT IN TO RETRIEVE THE NAV6 FILTER AND IT WAS REMOVED WITHOUT INCIDENT. REPEATED ANGIOGRAM AND IT WAS DISCOVERED THERE WAS NO FLOW AND THE PATIENT HAD A SPASM WHICH LED TO A STROKE. MEDICINE AND NURO INTERVENTION WAS PERFORMED TO TRY AND PULL OUT THE CLOT

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23817449 ↗
• MalfunctionDec 11, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT AN INTERNAL CAROTID ARTERY. THE 7-10/40 ACCULINK STENT DELIVERY SYSTEM TIP WAS NOTED TO BE SEPARATED ONCE REMOVED FROM THE PACKAGING AND WAS NOT USED IN THE ANATOMY. ANOTHER ACCULINK WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23780311 ↗
• MalfunctionOct 15, 2025Premature Activation; Deformation Due to Compressive Stress; Difficult to Advance; Premature Activation; Deformation Due to Compressive Stress; Difficult to Advance

  IT WAS REPORTED THAT DURING PREPARATION OF THE 6-8X40MM ACCULINK SELF-EXPANDING STENT SYSTEM THE STENT WAS OBSERVED TO BE EXPOSED AND NOT FLOWERED. ANOTHER NON-ABBOTT STENT WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. THERE WAS NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23293988 ↗

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