Acculink™ 1011338-30Recalls & reported problems
Abbott Vascular Inc. · RX ACCULINK™ Carotid Stent System 6.0 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
- 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 08717648076220), received between Apr 17, 2017 and Apr 5, 2023 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Activation Failure” (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
- Activation Failure1
- Device Expiration Issue1
- Improper or Incorrect Procedure or Method1
- Mechanical Jam1
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.
MalfunctionApr 5, 2023Mechanical Jam; Activation Failure; Mechanical Jam; Activation Failure
IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A HEAVILY CALCIFIED RIGHT INTERNAL CAROTID ARTERY THAT WAS 99% STENOSED. THE LESION WAS PRE-DILATATED WITH A 6X20MM VIATRAC BALLOON AT 20 ATMOSPHERES. THE 6X30MM ACCULINK HAD DIFFICULTY DEPLOYING AS RESISTANCE WAS NOTED WHEN PULLING THE HANDLE SLIDER; THEREFORE, IT WAS ONLY PARTIALLY DEPLOYED. THE DEVICE WAS REMOVED UNDER FLUOROSCOPY. A NEW UNSPECIFIED STENT WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. THERE WAS NO ADVERSE PATIENT EFFECTS REPORTED AND NO CLINICALLY SIGNIFICANT DELAY REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16685987 ↗MalfunctionApr 17, 2017Device Expiration Issue; Improper or Incorrect Procedure or Method
IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION IN THE RIGHT INTERNAL CAROTID ARTERY. A 6X30MM ACCULINK STENT WAS IMPLANTED AFTER EXPIRATION. PATIENT IN STABLE CONDITION POST PROCEDURE. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE AND NO ADVERSE PATIENT EFFECTS. NO ADDITIONAL INFORMATION WAS PROVIDED. NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 6498991 ↗
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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