AXS INFINITY LS GEN-10800-90Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 07613327298260), received between Jan 11, 2019 and May 26, 2026 — classified as 1 death, 4 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Deformation Due to Compressive Stress” (2 reports).

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 18, 2026.

Most reported problems

Recent adverse event reports

The 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• InjuryMay 26, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT 1 DAY POST PROCEDURE FOR AN INTRACRANIAL ANEURYSM, THE PATIENT DEVELOPED RIGHT GROIN PSEUDOANEURYSM. IT WAS TREATED WITH ULTRASOUND GUIDED THROMBIN INJECTION. THE EVENT WAS CAUSALLY RELATED TO PROCEDURE AND PROBABLY RELATED TO SUBJECT LONG SHEATH THAT WAS USED DURING THE PROCEDURE. THE EVENT WAS CONSIDERED AS A SERIOUS ADVERSE EVENT. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Aneurysm

  MAUDE report 25280446 ↗
• InjuryApr 21, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON 24-JAN-2023 WHILE PERFORMING A DSA (DIGITAL SUBTRACTION ANGIOGRAPHY) PATIENT SUFFERED STROKE, A NON OCCLUSIVE THROMBUS IN THE RIGHT DISTAL ACA TERRITORY AND MCA INFERIOR DIVISION WAS NOTICED. PATIENT WAS ADMINISTERED 2 MG TPA X 2 AND 2 MG INTEGRELLIN INJECTED IN THE A3 SEGMENT, AND 2 MG OF INTEGRELLIN INJECTED IN THE INFERIOR DIVISION OF MCA M4 SEGMENT WITH IMPROVEMENT SEEN OF DISTAL FLOW. STUDY DEVICE WAS NOT IMPLANTED DUE TO TREATMENT OF THE THROMBUS. IT WAS INDICATED THAT THE STROKE HAD CAUSAL RELATIONSHIP WITH THE STUDY PROCEDURE, AND HAS A POSSIBLE RELATIONSHIP WITH TO DAPT, OTHER STRYKER DEVICES (INCLUDING THE SUBJECT LONG SHEATH CATHETER) AND AN UNDERLYING CONDITION OR DISEASE. IT WAS NOTED THAT THE OUTCOME OF THE STROKE WAS RECOVERED/RESOLVED ON (B)(6) 2023. ON THE SAME DAY, POST PROCEDURE, PATIENT WAS EXTUBATED WITH CONCERN FOR NEW STROKE, TAKEN FOR CT HEAD, AT WHICH TIME SHE BECAME UNRESPONSIVE AND HYPOTENSIVE, REQUIRED INTUBATED, EMERGENT CTA ABD/PELVIS REVELING ACTIVE EXTRAVASATION FROM THE R CFA WITH ASSOCIATED HEMATOMA (RETROPERITONEAL HEMORRHAGE). PATIENT WAS TRANSFERRED EMERGENTLY TO NSICU AND VASCULAR SURGERY WAS CANCELLED. PATIENT INITIALLY

  Patient problems: Multiple Organ Dysfunction Syndrome; Retroperitoneal Hemorrhage; Stroke/CVA

  MAUDE report 16791900 ↗
• InjuryMar 30, 2021Difficult to Remove; Adverse Event Without Identified Device or Use Problem; Difficult to Remove; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING CAROTID STENTING PROCEDURE, THE SUBJECT SHEATH WAS INSERTED INTO THE PATIENT¿S ANATOMY VIA RADIAL ACCESS. THE SUBJECT SHEATH WENT UP EASILY INSIDE THE PATIENT¿S ANATOMY BUT WHEN IT REACHED BRACHIAL ARTERY, THE PHYSICIAN WAS UNABLE TO ADVANCE OR WITHDRAW THE SUBJECT SHEATH. IT IS NOT SURE IF THE CORRECT SIZE OF THE SUBJECT SHEATH WAS CHOSEN FOR THE SURGERY BECAUSE AN ULTRASOUND MEASUREMENT OF THE VESSEL WAS NOT PERFORMED. THE PATIENT WAS TAKEN INTO THE OPERATING ROOM FOR ADDITIONAL SURGERY WHERE THE PHYSICIAN TOOK OUT THE STUCK SUBJECT SHEATH ALONG WITH THE PATIENT'S ARTERY. THE CAROTID STENTING PROCEDURE WAS NOT COMPLETED BECAUSE OF THE INTERVENTION REQUIRED. IT WAS REPORTED THAT THE PATIENT WAS HAVING STROKES WHICH WAS NOT TREATED AT THAT TIME. NO FURTHER INFORMATION IS AVAILABLE AT THIS POINT.

  Patient problems: Stroke/CVA

  MAUDE report 11592485 ↗
• MalfunctionFeb 23, 2021Fracture; Fracture

  IT WAS REPORTED THAT AFTER THE CATHETER (SUBJECT DEVICE) WAS ENTERED INSIDE THE PATIENT'S ANATOMY VIA FEMORAL ACCESS POINT, THE MIDDLE OF THE SUBJECT CATHETER SHAFT BROKE IN HALF DURING THE PROCEDURE. THE BROKEN SHAFT OF THE SUBJECT CATHETER WAS REMOVED SUCCESSFULLY FROM THE PATIENT'S ANATOMY. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO CLINICAL CONSEQUENCES WERE REPORTED TO THE PATIENT DUE TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11369559 ↗
• MalfunctionJan 18, 2021Deformation Due to Compressive Stress; Deformation Due to Compressive Stress

  INITIALLY THE COMPLAINT WAS REPORTED FOR THE SUBJECT CATHETER SHAFT BEING KINKED/BENT. ANALYSIS OF THE RETURNED DEVICE FOUND THAT THE CATHETER SHAFT BROKEN/FRACTURED. THERE WERE NO CLINICAL CONSEQUENCES TO THE PATIENT REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11189870 ↗
• MalfunctionJan 18, 2021Deformation Due to Compressive Stress; Deformation Due to Compressive Stress

  INITIALLY THE COMPLAINT WAS REPORTED FOR THE SUBJECT CATHETER SHAFT BEING KINKED/BENT. ANALYSIS OF THE RETURNED DEVICE FOUND THAT THE CATHETER SHAFT BROKEN/FRACTURED. THERE WERE NO CLINICAL CONSEQUENCES TO THE PATIENT REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11189869 ↗
• DeathMar 12, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING A FLOW DIVERTER IMPLANT PROCEDURE, THE PHYSICIAN ADVANCED THE LONG SHEATH CATHETER (SUBJECT DEVICE) INTO THE INTERNAL CAROTID ARTERY (ICA) - PETROUS SEGMENT AND NOTICED A SMALL CLOT/THROMBUS IN A MIDDLE CEREBRAL ARTERY (M2) BRANCH. ATTEMPTS WERE MADE TO REMOVE THE CLOT WITH A STENT RETRIEVER (NON-STRYKER DEVICE) BUT ONLY LITTLE PORTION OF THE CLOT WAS REMOVED. IT WAS DECIDED TO PROCEED WITH THE FLOW DIVERTER IMPLANTATION IN THE ICA. PATIENT DIED POST-PROCEDURE. DURING PATHOLOGY EXAMINATION OF THE CLOT, IT WAS FOUND A FRAGMENT OF EMBEDDED REFRACTIVE, NON-POLARIZING FOREIGN MATERIAL. IT IS NOT KNOWN IF THE FOREIGN BODY WAS FROM THE SUBJECT DEVICE OR THE NON-STRYKER STENT RETRIEVER.

  Patient problems: Death; Device Embedded In Tissue or Plaque; Thromboembolism

  MAUDE report 9826306 ↗
• InjuryFeb 13, 2020Adverse Event Without Identified Device or Use Problem; Unintended Movement; Adverse Event Without Identified Device or Use Problem; Unintended Movement

  IT WAS REPORTED THAT WHILE THE SUBJECT CATHETER WAS BEING PULLED BACK ALONG WITH ANOTHER DEVICE DURING THE PROCEDURE, THE SUBJECT CATHETER JUMPED FORWARD AND DISSECTED THE INTERNAL CAROTID ARTERY INSIDE THE PATIENT'S ANATOMY. THE PHYSICIAN HAD TO EMBOLISM THE VESSEL AS A RESULT OF THE DISSECTION. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Embolism; Vascular Dissection

  MAUDE report 9709168 ↗
• MalfunctionJan 11, 2019Break; Break

  IT WAS REPORTED THAT DURING THE PROCEDURE, THE CATHETER BROKE. PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. NO CLINICAL CONSEQUENCES WERE REPORTED TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8242420 ↗