Absolute Pro 1012537-30Recalls & reported problems
Abbott Vascular Inc. · Absolute Pro Vascular Self-Expanding Stent System 9.0 mm x 30 mm x 135 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
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 08717648176210), received between Jul 16, 2025 and Jul 16, 2025 — classified as 1 injury.
The most frequently reported specific device problem is “Device Damaged by Another Device” (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.
Reports received per month
Most reported problems
Device problems
- Device Damaged by Another Device1
- Difficult to Advance1
- Improper or Incorrect Procedure or Method1
- Material Deformation1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryJul 16, 2025Improper or Incorrect Procedure or Method; Device Damaged by Another Device; Difficult to Advance; Material Deformation; Improper or Incorrect Procedure or Method; Device Damaged by Another Device; Difficult to Advance; Material Deformation
IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION IN THE LEFT COMMON FEMORAL ARTERY. A .018 GUIDEWIRE WAS ADVANCED AND THE 9.0X30MM ABSOLUTE PRO VASCULAR SELF-EXPANDING STENT SYSTEM (SESS) WAS DEPLOYED. THE .018 GUIDEWIRE WAS EXCHANGED FOR A .035 GUIDEWIRE TO GET MORE SUPPORT AND AN 8.0X40MM ARMADA 35 BALLOON WAS SUCCESSFULLY USED FOR POST DILATATION PER STANDARD PROCEDURE. BUT DURING ADVANCEMENT, THE BALLOON TOUCHED THE EDGE OF THE IMPLANTED STENT AND PUSHED THE IMPLANTED STENT SHORTENING/CRUSHING THE ABSOLUTE PRO VASCULAR STENT. ANOTHER 8.0X40MM ABSOLUTE PRO VASCULAR STENT WAS IMPLANTED TO EXTEND THE LENGTH OF THE PREVIOUSLY IMPLANTED ABSOLUTE PRO VASCULAR STENT. THERE WAS NO ADVERSE PATIENT EFFECT AND THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22523246 ↗
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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