Absolute Pro 1012531-100Recalls & reported problems
Abbott Vascular Inc. · Absolute Pro Vascular Self-Expanding Stent System 9.0 mm x 100 mm x 80 cm / Over-The-Wire · Class 3 · Implant
Data updated Oct 13, 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 08717648175817), received between Feb 20, 2026 and Feb 20, 2026 — classified as 1 injury.
The most frequently reported specific device problem is “Deformation Due to Compressive Stress” (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.
Reports received per month
Most reported problems
Device problems
- Deformation Due to Compressive Stress1
- Difficult or Delayed Activation1
- Difficult to Remove1
- Improper or Incorrect Procedure or Method1
- Malposition of Device1
- Material Separation1
- Physical Resistance/Sticking1
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.
InjuryFeb 20, 2026Difficult to Remove; Material Separation; Improper or Incorrect Procedure or Method; Difficult or Delayed Activation; Malposition of Device; Deformation Due to Compressive Stress; Physical Resistance/Sticking
IT WAS REPORTED THAT THE PROCEDURE PERFORMED WAS TO TREAT A DE NOVO, 70% STENOSED, MODERATELY CALCIFIED COMMON ILIAC ARTERY. THE 9.0X100MM ABSOLUTE PRO SELF-EXPANDING STENT SYSTEM (SESS) WAS ADVANCED; HOWEVER, DURING DEPLOYMENT THE THUMBWHEEL BECAME STUCK AND THE STENT ONLY PARTIALLY DEPLOYED. THE HANDLE WAS DISMANTLED IN AN ATTEMPT TO MANUALLY DEPLOY THE SES; HOWEVER, THIS WAS UNSUCCESSFUL. MULTIPLE ATTEMPTS WERE MADE TO REMOVE THE SESS, BUT RESISTANCE WAS MET WITH THE SHARP BIFURCATION AND THE SHEATH. DURING THE REMOVAL ATTEMPTS THE SHAFT KINKED AND SEPARATED HALF OUTSIDE THE BODY. FORCEPS WERE USED TO REMOVE THE SHAFT. THE SHEATH WAS PULLED BACK INTO THE AORTA AND THE STENT ULTIMATELY DEPLOYED, PARTIALLY IN AN UNINTENDED LOCATION OF THE AORTA AND PARTIALLY IN THE INTENDED AREA COVERING THE LESION TO THE PHYSICIAN'S SATISFACTION. THERE WERE NO ADVERSE PATIENT SEQUELAE AND NO CLINICALLY SIGNIFICANT DELAY IN PROCEDURE. FURTHER REVIEW OF THE PART AND LOT NUMBER FOUND THAT THE ABSOLUTE PRO SESS WAS USED AFTER EXPIRATION. NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24405925 ↗
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.
How reports and recalls are matched · Editorial policy · Report an error on this page