Absolute Pro 1012528-30Recalls & reported problems
Abbott Vascular Inc. · Absolute Pro Vascular Self-Expanding Stent System 6.0 mm x 30 mm x 80 cm / Over-The-Wire · Class 3 · Implant
Data updated Oct 13, 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 08717648175534), received between Oct 4, 2019 and Oct 4, 2019 — classified as 1 malfunction.
The most frequently reported specific device problem is “Defective Device” (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. How this data works · Data updated Oct 13, 2026.
Most reported problems
Device problems
- Defective Device1
- Off-Label Use1
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.
MalfunctionOct 4, 2019Off-Label Use; Defective Device; Off-Label Use; Defective Device
IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A LESION IN THE CEPHALIC VEIN WITH 70% STENOSIS. A 6.0 X 30 MM ABSOLUTE PRO VASCULAR SELF EXPANDING STENT SYSTEM (SESS) WAS PREPPED AS PER THE INSTRUCTIONS FOR USE AND WAS ADVANCED TO THE LESION. ON REVIEW OF THE SESS POSITION UNDER IMAGING, IT WAS NOTED THAT THE STENT WAS BEYOND THE MARKERS OF THE DELIVERY SYSTEM. THE SESS WAS NOT DEPLOYED AND SIMPLY REMOVED FROM THE PATIENT. OUTSIDE OF THE ANATOMY, THE STENT OF THE SESS WAS MEASURED AND WAS REPORTEDLY 1MM LONGER THAN IT WAS EXPECTED TO BE. THE STENT WAS UNEXPANDED AND DID NOT APPEAR TO HAVE MOVED ON THE DELIVERY SYSTEM. A NEW UNSPECIFIED ABSOLUTE PRO VASCULAR STENT WAS DEPLOYED TO 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 Consequences Or Impact To Patient
MAUDE report 9157790 ↗
Other STENT, ILIAC devices
- Cordis S.M.A.R.T. Control Vascular Stent System C10040MLCordis US Corp. · STENT, ILIAC1 recall3 reports
- Absolute Pro 1012534-100Abbott Vascular Inc. · STENT, ILIAC51 reports
- Protégé™ GPS™ SERB65-09-60-80Ev3, Inc · STENT, ILIAC1 recall0 reports
- Cordis S.M.A.R.T. Control Vascular Stent System C09060MLCordis US Corp. · STENT, ILIAC1 recall0 reports
- Absolute Pro 1012535-100Abbott Vascular Inc. · STENT, ILIAC1 death41 reports
- Omnilink Elite 1012631-39Abbott Vascular Inc. · STENT, ILIAC27 reports
- Omnilink Elite 1012632-29Abbott Vascular Inc. · STENT, ILIAC25 reports
- Omnilink Elite 1012631-59Abbott Vascular Inc. · STENT, ILIAC21 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 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
How reports and recalls are matched · Editorial policy · Report an error on this page