Absolute Pro 1012529-80Recalls & reported problems
Abbott Vascular Inc. · Absolute Pro Vascular Self-Expanding Stent System 7.0 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
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 08717648175640), received between Dec 16, 2016 and Jan 22, 2019 — classified as 1 injury, 1 malfunction.
The most frequently reported specific device problem is “Device Contaminated During Manufacture or Shipping” (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
- Adverse Event Without Identified Device or Use Problem1
- Device Contaminated During Manufacture or Shipping1
Patient problems
- Hypersensitivity/Allergic reaction1
- No Patient Involvement1
- Numbness1
- Pain1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionJan 22, 2019Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping
IT WAS REPORTED THAT DURING INSPECTION FOR CONSIGNMENT RETURN PRODUCTS, A SMALL, WHITE, CRESCENT SHAPED FOREIGN MATERIAL WAS FOUND INSIDE THE STERILE POUCH OF THE OF THE ABSOLUTE PRO VASCULAR SELF EXPANDING STENT SYSTEM (SESS). REPORTEDLY, THE DEVICE WAS SEALED AND HAD NOT BEEN OPENED. THE DEVICE WAS NOT USED AND THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION WAS PROVIDED. RETURNED DEVICE ANALYSIS IDENTIFIED THE FOREIGN MATERIAL AS A POTENTIAL MANUFACTURING COMPONENT.
Patient problems: No Patient Involvement
MAUDE report 8269445 ↗InjuryDec 16, 2016Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THE PATIENT HAD THREE OMNI ELITE AND ONE ABSOLUTE PRO STENTS IMPLANTED IN THE RIGHT COMMON ILIAC AND LEFT COMMON ILIAC ARTERIES ON (B)(6) 2013. APPROXIMATELY A YEAR LATER, THE PATIENT STARTED EXPERIENCING TINGLING AND SEVERE PAIN DOWN BOTH LEGS. MEDICATION HAS BEEN PRESCRIBED. THE PATIENT HAS ALWAYS BEEN SENSITIVE TO METAL; THEREFORE, AN ALLERGY KIT HAS BEEN REQUESTED BY THE ALLERGIST. ADDITIONALLY, THE PATIENT SUFFERS OF AN OCCLUSIVE PERIPHERAL DISEASE. NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: Hypersensitivity/Allergic reaction; Numbness; Pain
MAUDE report 6182543 ↗
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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