Absolute Pro 1012528-60Recalls & reported problems
Abbott Vascular Inc. · Absolute Pro Vascular Self-Expanding Stent System 6.0 mm x 60 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
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 08717648175558), received between Oct 7, 2017 and Jun 4, 2018 — classified as 1 injury, 1 malfunction.
The most frequently reported specific device problem is “Difficult To Position” (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 To Position1
- Difficult or Delayed Positioning1
- Premature Activation1
Patient problems
- No Consequences Or Impact To Patient2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionJun 4, 2018Difficult To Position; Premature Activation
IT WAS REPORTED THAT THIS WAS A PERCUTANEOUS INTERVENTION TREATING THE ILIAC ARTERY, MODERATELY CALCIFIED LESION. A 7 FRENCH TERUMO CATHETER WAS PLACED. FOLLOWING, AN ABSOLUTE PRO STENT DELIVERY SYSTEM (SDS) WAS ADVANCED WITHIN THE CATHETER, HOWEVER, RESISTANCE WAS MET WITHIN THIS CATHETER. THE ABSOLUTE PRO SDS WAS REMOVED FROM THE CATHETER WITHOUT RESISTANCE. ONCE OUTSIDE THE PATIENT'S ANATOMY, THE STENT WAS NOTED TO BE PARTIALLY DEPLOYED. ANOTHER ABSOLUTE PRO WAS USED IN REPLACEMENT WITHOUT ISSUE. THERE WERE NO ADVERSE PATIENT EFFECTS AND THERE WAS NO CLINICALLY SIGNIFICANT DELAY. NO ADDITIONAL INFORMATION WAS PROVIDED REGARDING THIS ISSUE.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7567600 ↗InjuryOct 7, 2017Difficult or Delayed Positioning
IT WAS REPORTED THE PROCEDURE WAS PERFORMED TO TREAT A LESION IN THE SUPERFICIAL FEMORAL ARTERY (SFA) AND THE ILIAC VESSEL, BOTH WITH MODERATE CALCIFICATION. THE 7X150MM ARMADA 35 BALLOON DILATATION CATHETER (BDC) WAS ADVANCED TO THE SFA LESION WITHOUT ISSUE, BUT RUPTURED AT 5 ATMOSPHERES. THE BDC WAS REMOVED WITHOUT ISSUE AND REPLACED WITH A NEW ARMADA 35 BDC. THE 6.0X60MM ABSOLUTE PRO VASCULAR STENT DELIVERY SYSTEM (SDS) WAS ADVANCED TO THE ILIAC LESION. MID-DEPLOYMENT, THE THUMBWHEEL JAMMED. THE HANDLE WAS CRACKED OPEN, AND THE STENT WAS DEPLOYED MANUALLY. 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 6927307 ↗
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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