Acculink™ 1011340-40Recalls & reported problems
Abbott Vascular Inc. · RX ACCULINK™ Carotid Stent System 8.0 mm x 40 mm x 132 cm Rapid-Exchange · Class 3 · Implant
All models of Acculink (13)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 08717648076299), received between Aug 9, 2019 and Feb 16, 2024 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Difficult to Remove” (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.
Reports received per month
Most reported problems
Device problems
- Difficult to Remove1
- Failure to Advance1
- Malposition of Device1
- Material Separation1
- Off-Label Use1
- Premature Activation1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionFeb 16, 2024Malposition of Device; Malposition of Device
IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A RIGHT INTERNAL CAROTID LESION. DURING DEPLOYMENT OF AN 8X40MM ACCULINK STENT, THE STENT JUMPED FORWARD AND DID NOT COVER THE ENTIRE TARGET LESION. AN 8X30MM ACCULINK STENT WAS DEPLOYED TO SUCCESSFULLY COMPLETE THE PROCEDURE. 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 18727602 ↗MalfunctionAug 9, 2019Premature Activation; Off-Label Use; Difficult to Remove; Material Separation; Failure to Advance; Premature Activation; Off-Label Use; Difficult to Remove; Material Separation; Failure to Advance
SUBSEQUENT TO THE 30-DAY INITIAL MEDWATCH REPORT, THE FOLLOWING INFORMATION WAS RECEIVED: ON ATTEMPTED REMOVAL OF THE 8 X 40 MM ACCULINK SELF EXPANDING STENT SYSTEM (SESS), RESISTANCE WITH THE GUIDING CATHETER WAS MET AND FORCE WAS APPLIED. THE SHAFT OF THE SESS SEPARATED. AS THE SITE OF THE SEPARATION WAS WITHIN THE GUIDE CATHETER, THE DISTAL PORTION OF THE SESS WAS SIMPLY REMOVED WITH THE GUIDE CATHETER AS A SINGLE UNIT. NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8880839 ↗
Other STENT, CAROTID devices
- Neuroguard IEP® System NG-0740-140-2Contego Medical, Inc. · Stent, Carotid2 recalls32 reports
- Neuroguard IEP® System NG-NV-6-40Contego Medical, Inc. · Stent, Carotid2 recalls9 reports
- Neuroguard IEP® System NG-NV-7-40Contego Medical, Inc. · Stent, Carotid2 recalls8 reports
- ENROUTE Transcarotid Stent SR-0940-CSSilk Road Medical, Inc. · Stent, Carotid1 recall5 deaths58 reports
- Neuroguard IEP® System NG-0640-140-2Contego Medical, Inc. · Stent, Carotid2 recalls7 reports
- ENROUTE Transcarotid Stent SR-1040-CSSilk Road Medical, Inc. · Stent, Carotid1 recall3 deaths56 reports
- CGuard Prime Carotid Stent System CND0840Inspire M.D Ltd · Stent, Carotid1 recall1 death41 reports
- CGuard Prime Carotid Stent System CND0940Inspire M.D Ltd · Stent, Carotid1 recall31 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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