Absolute Pro 1012531-80Recalls & reported problems
Abbott Vascular Inc. · Absolute Pro Vascular Self-Expanding Stent System 9.0 mm x 80 mm x 80 cm / Over-The-Wire · Class 3 · Implant
All models of Absolute Pro (51)
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 08717648175800), received between Feb 10, 2017 and Apr 5, 2021 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Difficult or Delayed Activation” (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 Activation1
- Physical Resistance/Sticking1
- Positioning Failure1
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, 2021Difficult or Delayed Activation; Physical Resistance/Sticking; Difficult or Delayed Activation; Physical Resistance/Sticking
IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A CALCIFIED LESION IN THE ILIAC VESSEL. THE 9.0 X 80 MM ABSOLUTE PRO SELF EXPANDING STENT SYSTEM WAS ADVANCED TO THE TARGET LESION. DURING STENT DEPLOYMENT, THE DEPLOYMENT WHEEL STOPPED HALF WAY THROUGH DEPLOYMENT, BUT WITH MANIPULATION THE STENT WAS ABLE TO COMPLETELY DEPLOY AT THE INTENDED SITE. POST DILATATION WAS COMPLETED SUCCESSFULLY. THERE WAS NO ADVERSE PATIENT EFFECT AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11616405 ↗MalfunctionFeb 10, 2017Positioning Failure
ADDITIONAL INFORMATION: RETURN DEVICE ANALYSIS FOUND THAT THE STENT HOLDER (INNER MEMBER) OF THE ABSOLUTE PRO WAS RETURNED SEPARATED ON A VERSACORE 035" GUIDE WIRE. FOLLOW-UP WITH THE ACCOUNT CONFIRMED THAT THERE WAS RESISTANCE DURING REMOVAL OF THE STENT DELIVERY SYSTEM WITH THE GUIDE WIRE; HOWEVER, THEY COULD NOT RECALL ANYTHING ABOUT THE SEPARATION. NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 6323366 ↗
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
- Cordis S.M.A.R.T. Control Vascular Stent System C09060MLCordis US Corp. · STENT, ILIAC1 recall0 reports
- Protégé™ GPS™ SERB65-09-60-80Ev3, Inc · 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 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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