AXS INFINITY LS PLUSRecalls & reported problems across all models
Stryker Corporation · 3 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 30
- Deaths reported
- 0
- Injuries reported
- 11
- Recalls
- 0
We found 3 models of AXS INFINITY LS PLUS by Stryker Corporation in the FDA's device registry (GUDID). Together they are named in 30 adverse event reports in the FDA's MAUDE database, received between Nov 20, 2018 and Nov 24, 2025 — classified as 11 injuries, 19 malfunctions.
The most frequently reported specific device problem is “Break” (18 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
Most reported AXS INFINITY LS PLUS problems
Device problems
- Break18
- Fracture11
- Fluid/Blood Leak2
- Adverse Event Without Identified Device or Use Problem1
- Peeled/Delaminated1
Patient problems
- No Consequences Or Impact To Patient14
- No Clinical Signs, Symptoms or Conditions11
- No Known Impact Or Consequence To Patient5
- No Patient Involvement2
- Hemorrhage/Blood Loss/Bleeding1
AXS INFINITY LS PLUS models
3 models, most reported first. Each model has its own page with its reports, recalls and device details.
- AXS INFINITY LS PLUS INC-11196-90Catheter, percutaneous26 reports
- AXS INFINITY LS PLUS INC-11196-70Catheter, percutaneous2 reports
- AXS INFINITY LS PLUS INC-11196-80Catheter, percutaneous2 reports
Recent AXS INFINITY LS PLUS adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionNov 24, 2025Fracture; Fracture
IT WAS REPORTED THAT DURING THE PROCEDURE, WHEN REMOVING FROM PATIENT THE SUBJECT CATHETER TIP WAS UNRAVELED/DECONSTRUCTED. THE SUBJECT DEVICE WAS REPLACED, AND 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 23632598 ↗MalfunctionAug 15, 2023Fracture; Fracture
IT WAS REPORTED THAT DURING A NEUROVASCULAR PROCEDURE THE SUBJECT CATHETER UNRAVELED WHEN PULLED OUT OF THE PATIENT'S BODY. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO FURTHER INFORMATION IS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17552991 ↗InjuryJan 27, 2023Fracture; Fracture
B5 - IT WAS REPORTED THAT DURING EVT (ENDOVASCULAR THROMBECTOMY) PROCEDURE, IN A PATIENT WHO HAD A DIFFICULT AORTIC ARCH AND CERVICAL ICA (INTERNAL CAROTID ARTERY) TANDEM OCCLUSION, THERE WAS EXTREME KINKING OF THE CATHETER (SUBJECT DEVICE) IN THE AORTIC ARCH. THIS WAS NOTICED DURING THE SECOND PASS WHEN AN INTERMEDIATE CATHETER WAS UNABLE TO BE ADVANCED WITHIN THE CATHETER (SUBJECT DEVICE), STENT RETRIEVER WAS DEPLOYED IN M1. WITHDREW THE SYSTEM INTO THE AORTIC ARCH AND PULLED OUT THE STENT RETRIEVER. THE INTERMEDIATE CATHETER WOULD NOT COME OUT FROM THE KINKED CATHETER. IT WAS NOT POSSIBLE TO STRAIGHTEN OUT THIS KINK IN THE AORTIC ARCH, DESPITE ATTEMPTS TO PASS A WIRE. A SNARE WAS PASSED FROM THE RADIAL ARTERY TO SNARE THE CATHETER (SUBJECT DEVICE) FROM THE TOP AND PULLED THE CATHETER (SUBJECT DEVICE) FROM THE FEMORAL ACCESS SITE. THIS PULLED APART THE CATHETER (SUBJECT DEVICE) AND REMOVED THE GUIDE CATHETER (SUBJECT DEVICE) THROUGH THE 8F SHEATH, BUT THE CATHETER (SUBJECT DEVICE) BECAME UNWOUND/SPLIT APART DURING THIS PROCESS. THERE WAS 60-90 MINUTES SURGICAL DELAY. THE EVT PROCEDURE WAS TERMINATED EARLY. NO CLINICAL CONSEQUENCES WERE REPORTED TO THE PATIENT DUE TO THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16261065 ↗InjuryMay 12, 2022Fracture; Fracture
IT WAS REPORTED DURING AN ENDOVASCULAR PROCEDURE THE SUBJECT CATHETER BROKE INSIDE THE PATIENT. THE PHYSICIAN USED A SNARE TO REMOVE THE FRACTURED SUBJECT CATHETER FRAGMENT RESULTING IN AN ADDITIONAL 30 MINUTES TO COMPLETE THE PROCEDURE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO CLINICAL CONSEQUENCES TO THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14380757 ↗InjuryJan 24, 2022Fracture; Fracture
IT WAS REPORTED THAT DURING THE PROCEDURE, THE PROXIMAL END OF THE SUBJECT CATHETER WAS FOUND KINKED DURING PREPARATION. THE RESISTANCE WAS FELT AT THE PROXIMAL PORTION OF THE SUBJECT CATHETER WHILE ADVANCING INSIDE THE DILATOR AND ADVANCING THE GUIDE CATHETER INSIDE THE SUBJECT CATHETER. AFTER REMOVING THE OCCLUSION FROM THE PATIENT ANATOMY, WHILE PERFORMING A RUN ON THE TARGET VESSEL THE PHYSICIAN FOUND THE TIP OF THE SUBJECT CATHETER BROKE INSIDE THE PATIENT ANATOMY. THE PHYSICIAN USED FORCEPS TO TRACK OVER A WIRE AND RETRIEVED THE BROKEN FRAGMENT OUT OF THE PATIENT'S ANATOMY. THE PATIENT IS DOING WELL AND WAS NOT IMPACTED LONG-TERM. NO ADDITIONAL INFORMATION WAS PROVIDED REGARDING THE PATIENT IMPACT DUE TO THIS EVENT
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13333571 ↗MalfunctionDec 3, 2021Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED THAT DURING THE ACUTE ISCHEMIC STROKE PROCEDURE WHEN THE SUBJECT CATHETER WAS PARTIALLY INSERTED INTO THE PATIENT'S BODY THE PHYSICIAN NOTICED A LEAK AT THE JUNCTION BETWEEN THE HUB AND MICROCATHETER SHAFT. THE PHYSICIAN REPLACED IT WITH A NEW DEVICE AND CONTINUED THE PROCEDURE WITHOUT CLINICAL CONSEQUENCES TO THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12925277 ↗InjuryJan 5, 2021Fracture; Fracture
IT WAS REPORTED THAT A PATIENT WAS TREATED FOR A STROKE USING THE SUBJECT CATHETER. THE SUBJECT CATHETER UNRAVELED AT THE COIL AND BEGAN PULLING AWAY FROM THE CATHETER ITSELF. THE OUTER SHEATH OF THE CATHETER WAS BROKEN OFF. VASCULAR SURGEON WAS CALLED AND ASSISTED TO ¿CUT-DOWN¿ AT THE RADIAL ARTERY TO REMOVE THE CATHETER. ALL PART OF THE CATHETER WAS REMOVED FROM THE PATIENT ANATOMY. THERE WERE NO CLINICAL CONSEQUENCES REPORTED DUE TO THIS EVENT. THE PATIENT IS DOING WELL.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11115374 ↗InjuryDec 28, 2020Fracture; Fracture
IT WAS REPORTED THAT DURING THE PROCEDURE AT ACCESS VIA RADIAL ARTERY TO DELIVERY THROMBECTOMY DEVICES THE CATHETER (SUBJECT DEVICE) DISTAL SHAFT WAS BROKEN OFF INSIDE PATIENT. ANOTHER SURGERY WAS PERFORMED TO REMOVE THE BROKEN FRAGMENTS OF THE CATHETER. THE PATIENTS MEDICAL CONDITION WAS GOOD. THERE WERE NO CLINICAL CONSEQUENCES TO THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11083718 ↗InjuryNov 2, 2020Fracture; Adverse Event Without Identified Device or Use Problem; Fracture; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT DURING A PCA THE CATHETER (SUBJECT DEVICE) SEPARATED FROM THE SHEATH AND WAS BROKEN. THE PHYSICIAN CLAMPED THE SUBJECT CATHETER TO STOP BLOOD LOSS. ALL BROKEN FRAGMENTS WERE REMOVED FROM THE PATIENT. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WERE NO CLINICAL CONSEQUENCES TO THE PATIENT.
Patient problems: Hemorrhage/Blood Loss/Bleeding
MAUDE report 10775420 ↗InjurySep 6, 2020Fracture; Peeled/Delaminated; Fracture; Peeled/Delaminated
IT WAS REPORTED THAT THE SUBJECT CATHETER WAS USED TO TREAT AN ACUTE STROKE PATIENT. A LOT OF RESISTANCE WAS ENCOUNTERED WHEN THE PHYSICIAN TRIED TO INSERT THE SUBJECT CATHETER THROUGH THE RIGHT FEMORAL ARTERY. GUIDEWIRE WAS ADVANCED THROUGH THE CATHETER AND THEN THE SUBJECT CATHETER WAS ABLE TO TRACK THE DEVICE INSIDE THE PATIENT ANATOMY, BUT IT GOT STUCK. THE PHYSICIAN ATTEMPTED TO PULL THE SUBJECT CATHETER OUT, BUT IT WAS STUCK. THE PHYSICIAN WAS FINALLY ABLE TO TAKE OUT THE SUBJECT CATHETER OUT OF THE PATIENT ANATOMY; HOWEVER, THE DISTAL TIP OF THE CATHETER WAS MISSING, AND THE DISTAL HALF OF THE POLYMER JACKET WAS NOT ON THE CATHETER AND THE CATHETER WAS FOUND STRETCHED. THE PHYSICIAN THEN WENT THROUGH THE RADIAL ARTERY TO TREAT THE MIDDLE CEREBRAL ARTERY (MCA) STROKE. THE PHYSICIAN WAS ABLE TO ASPIRATE THE CLOT AND OPENED THE VESSEL. THE POLYMER JACKET WAS FOUND BALLED UP AT THE PUNCTURE SIGHT. THEN THE PATIENT UNDERWENT AN ADDITIONAL SURGERY TO REMOVE THE CATHETER TIP FROM THE VESSEL AND THE OUTER LAYER OF THE CATHETER THAT WAS BALLED UP AT THE PUNCTURE SITE. THE PATIENT IS DOING FINE. THERE WERE NO CLINICAL CONSEQUENCES TO THE PATIENT REPORTED DUE TO THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions; No Known Impact Or Consequence To Patient
MAUDE report 10498337 ↗MalfunctionJul 14, 2020Fracture; Fracture
IT WAS REPORTED THAT DURING PROCEDURE, THE SUBJECT CATHETER WAS USED TO ACCESS THE FEMORAL SITE AND THE HUB WAS SEPARATED FROM THE SUBJECT CATHETER. THE SUBJECT CATHETER WAS REMOVED AND REPLACED WITH ANOTHER GUIDE CATHETER. IT WAS SUSPECTED THAT THE SUBJECT CATHETER WAS USED IN A LONG STROKE CASE WHICH COULD CAUSE OF THE BREAK. THE PROCEDURE COMPLETED WITHOUT CLINICAL CONSEQUENCES TO THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient
MAUDE report 10274119 ↗MalfunctionJul 7, 2020Fracture; Fracture
IT WAS REPORTED THAT DURING THE PROCEDURE, THE PROXIMAL END OF THE CATHETER (SUBJECT DEVICE) SHAFT BROKE WHEN THE PHYSICIAN USED FEMORAL SIDE AS THE ACCESS POINT. ALL THE FRACTURED PARTS OF THE SUBJECT CATHETER WERE REMOVED SUCCESSFULLY FROM THE PATIENT'S ANATOMY. THE PHYSICIAN REPLACED IT WITH A NEW DEVICE AND CONTINUED THE PROCEDURE WITHOUT CLINICAL CONSEQUENCES TO THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient
MAUDE report 10239485 ↗MalfunctionApr 26, 2019Break; Break
IT WAS REPORTED THAT WHILE TRACKING, THE SUBJECT DEVICE CATHETER WAS FRACTURED IN THE MIDDLE OF THE CATHETER. THERE WERE NO CLINICAL CONSEQUENCES TO THE PATIENT DUE TO THE REPORTED EVENT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8557421 ↗MalfunctionApr 25, 2019Break; Break
ANALYSIS OF THE RETUNED DEVICE FOUND THAT THE GUIDE CATHETER SHAT BROKEN. THERE WERE NO CLINICAL CONSEQUENCES TO THE PATIENT AS A RESULT OF THIS EVENT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8553249 ↗InjuryApr 12, 2019Break; Break
IT WAS REPORTED THAT THE PROXIMAL SECTION OF THE GUIDE CATHETER(SUBJECT DEVICE) BROKE DURING REMOVAL PATIENT FROM THE PATIENT AT THE END OF THE PROCEDURE. THE PHYSICIAN USED A GUIDEWIRE TO REMOVE ALL OF THE THE BROKEN GUIDE CATHETER FROM THE PATIENT. THERE WERE NO REPORTED CLINICAL CONSEQUENCES TO THE PATIENT.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8511759 ↗
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Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- 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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