Absolute Pro 1012529-30Recalls & reported problems
Abbott Vascular Inc. · Absolute Pro Vascular Self-Expanding Stent System 7.0 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
- 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 08717648175619), received between Jun 24, 2021 and Feb 16, 2022 — classified as 1 injury, 1 malfunction.
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. How this data works · Data updated Oct 13, 2026.
Most reported problems
Device problems
- Activation Failure1
- Migration1
- Off-Label Use1
- Patient-Device Incompatibility1
Patient problems
- Device Embedded In Tissue or Plaque1
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionFeb 16, 2022Activation Failure; Activation Failure
IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT THE LEFT BASILIC ARTERY. THE ABSOLUTE PRO STENT SYSTEM WAS ADVANCED PAST A SHARP TURN/ANGLE TO GET TO THE LESION. DEPLOYMENT WAS ATTEMPTED, BUT COMPLETELY FAILED. THE DEVICE WAS REMOVED WITH THE STENT; HOWEVER, IT WAS NOTICED THAT THERE WAS A SPACE BETWEEN THE DISTAL SHEATH AND THE TIP OF THE CATHETER. THERE WAS NO ADVERSE PATIENT EFFECT AND NO CLINICALLY SIGNIFICANT DELAY IN PROCEDURE. ANOTHER ABSOLUTE PRO WAS DEPLOYED TO COMPLETE THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13546711 ↗InjuryJun 24, 2021Off-Label Use; Patient-Device Incompatibility; Migration; Off-Label Use; Patient-Device Incompatibility; Migration
IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT AN ARTERIOVENOUS FISTULA IN THE LEFT BASILIC. A FISTULAGRAM WAS PERFORMED. A 7X30MM ABSOLUTE PRO STENT WAS DEPLOYED AT THE LESION WITHOUT ISSUE. HOWEVER, IT WAS THEN NOTED THAT THE STENT IMPLANT WAS NOT FULLY APPOSED TO THE VESSEL WALL AND HAD MIGRATED DISTALLY TOWARDS THE LEFT AUXILIARY. IT WAS DECIDED TO DILATE THE STENT IMPLANT IN PLACE (NON TARGET LESION). A 7X40MM ABSOLUTE PRO WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE AT THE TARGET LESION. THERE WAS NO ADVERSE PATIENT SEQUELA AND NO CLINICALLY SIGNIFICANT DELAY. NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: Device Embedded In Tissue or Plaque
MAUDE report 12062936 ↗
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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