Absolute Pro 1012528-80Recalls & reported problems
Abbott Vascular Inc. · Absolute Pro Vascular Self-Expanding Stent System 6.0 mm x 80 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 08717648175565), received between Aug 18, 2021 and Aug 18, 2021 — classified as 1 malfunction.
The most frequently reported specific device problem is “Failure to Advance” (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
- Failure to Advance1
- Premature Activation1
Patient problems
- Pain1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 18, 2021Premature Activation; Failure to Advance; Premature Activation; Failure to Advance
IT WAS REPORTED THAT THIS WAS A PROCEDURE TO TREAT THE MID SUPERFICIAL FEMORAL ARTERY (SFA) WITH HEAVY CALCIFICATION. THE 6.0X80 MM ABSOLUTE PRO SELF EXPANDING STENT SYSTEM (SESS) DEVICE WAS ADVANCED; HOWEVER RESISTANCE WAS MET WITH THE ANATOMY. THEN PRIOR TO REACHING THE TARGET LESION, IT WAS OBSERVED THAT THE STENT WAS FLOWERED. THE STENT WAS COMING OUT OF THE SHEATH. THEREFORE, THE PHYSICIAN REMOVED THE DEVICE FROM THE PATIENT WITHOUT ISSUE. BALLOON ANGIOPLASTY WAS PERFORMED. THEN A 5.5X120 MM SUPERA SESS WAS ADVANCING, BUT COULD NOT CROSS THE TARGET LESION DUE TO ANATOMICAL CHALLENGES AS WELL. THEREFORE THE DEVICE WAS REMOVED WITHOUT ISSUE. ADDITIONAL BALLOONING WAS PERFORMED TO OPEN UP THE CALCIFICATION. THE SUPERA SESS WAS RE-ADVANCED, BUT STILL COULD NOT CROSS THE TARGET LESION DUE TO THE ANATOMY. THEREFORE, THE SUPERA SESS WAS REMOVED AGAIN WITHOUT ISSUE AND THE PROCEDURE WAS ABORTED. THIS CAUSED A DELAY AND THE PATIENT WAS SUFFERING FROM BACK PAIN FROM LAYING DOWN SO LONG. THE ISSUES ADVANCING BOTH DEVICES TOOK SEVERAL HOURS WHICH IS WHY THE PATIENT HAD BACK PAIN. THE PATIENT WAS TRANSFERRED TO THE POST OP ROOM AND THE BACK PAIN SUBSIDED ON ITS OWN. THE PATIENT IS STABLE A
Patient problems: Pain
MAUDE report 12339083 ↗
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.
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