Acculink™ 1011340-30Recalls & reported problems
Abbott Vascular Inc. · RX ACCULINK™ Carotid Stent System 8.0 mm x 30 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
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 08717648076282), received between May 9, 2019 and May 9, 2019 — classified as 1 malfunction.
The most frequently reported specific device problem is “Difficult or Delayed Positioning” (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
Device problems
- Difficult or Delayed Positioning1
- Malposition of Device1
Patient problems
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 9, 2019Difficult or Delayed Positioning; Malposition of Device; Difficult or Delayed Positioning; Malposition of Device
IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A MODERATELY TORTUOUS LESION IN THE INTERNAL CAROTID ARTERY. AN 8/30 ACCULINK II SELF EXPANDING STENT DELIVERY SYSTEM WAS ADVANCED TO THE LESION WITH NO RESISTANCE; HOWEVER, THE STENT WAS DIFFICULT TO VISUALIZE AND APPEARED TO JUMP ON DEPLOYMENT. THE STENT WAS ULTIMATELY DEPLOYED PARTIALLY INSIDE THE TARGET LESION, LEAVING PART OF THE LESION UNCOVERED. A SECOND UNSPECIFIED ACCULINK STENT WAS DEPLOYED TO TREAT THE REMAINDER OF THE LESION. THERE WAS NO REPORTED ADVERSE PATIENT SEQUELA AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8597646 ↗
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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