AXS INFINITY LS PLUS INC-11196-90Recalls & reported problems

Summary

The FDA's MAUDE database contains 26 adverse event reports that list this exact device (DI 07613327459203), received between Dec 3, 2018 and Nov 24, 2025 — classified as 10 injuries, 16 malfunctions.

The most frequently reported specific device problem is “Break” (15 reports).

1 other recall cover devices cleared under the same FDA submission (K172468, K193034); they may or may not involve this specific model.

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 25 most recent of 26 reports, 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 ↗
• 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 ↗
• MalfunctionApr 4, 2019Break; Break

  IT WAS REPORTED THAT WHILE ADVANCING THE GUIDE CATHETER (SUBJECT DEVICE) DURING A PROCEDURE, THE PHYSICIAN EXPERIENCED FRICTION AROUND THE CATHETER HUB AREA AND THE SUBJECT DEVICE FRACTURED. THERE WERE NO REPORTED CLINICAL CONSEQUENCES TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8485180 ↗
• MalfunctionApr 4, 2019Break; Break

  IT WAS REPORTED THAT WHILE ADVANCING THE GUIDE CATHETER (SUBJECT DEVICE) DURING A PROCEDURE, THE PHYSICIAN EXPERIENCED FRICTION AROUND THE CATHETER HUB AREA AND THE SUBJECT DEVICE FRACTURED. THERE WERE NO REPORTED CLINICAL CONSEQUENCES TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8485177 ↗
• MalfunctionMar 27, 2019Break; Break

  IT WAS REPORTED THAT DURING THE PROCEDURE, THE GUIDE CATHETER SHAFT (SUBJECT DEVICE) FRACTURED INSIDE THE PATIENT. THE PHYSICIAN REPLACED IT WITH A NEW GUIDE CATHETER AND CONTINUED THE PROCEDURE WITHOUT CLINICAL CONSEQUENCES TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8458525 ↗
• MalfunctionMar 11, 2019Break; Break

  IT WAS REPORTED THAT THE GUIDE CATHETER HAD FRACTURED INSIDE THE PATIENT DURING THE PROCEDURE. THE PHYSICIAN REPLACED IT WITH A NEW GUIDE CATHETER AND CONTINUED THE PROCEDURE WITHOUT CLINICAL CONSEQUENCES TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8408897 ↗
• InjuryFeb 27, 2019Break; Break

  DURING THE PROCEDURE, IT WAS REPORTED THAT THE LONG SHEATH CATHETER BROKE IN HALF INSIDE THE PATIENT AND WAS RETRIEVED WITH FORCEPS AFTER. NO CLINICAL CONSEQUENCES REPORTED TO THE PATIENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8375514 ↗
• MalfunctionFeb 22, 2019Break; Break

  IT WAS REPORTED THAT DURING PROCEDURE WHILE THE GUIDE CATHETER (SUBJECT DEVICE) WAS ADVANCED INTO THE PATIENT GROIN PUNCTURE SITE, THE GUIDE CATHETER BROKE. THERE WERE NO CLINICAL CONSEQUENCES TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8364658 ↗
• InjuryFeb 15, 2019Break; Break

  IT WAS REPORTED THAT WHILE TRACKING THROUGH THE PATIENT'S ANATOMY, THE GUIDE CATHETER(SUBJECT DEVICE) HAD FRACTURED INSIDE THE PATIENT. THE PHYSICIAN REMOVED THE BROKEN DEVICE AND AS A RESULT, WAS UNABLE TO COMPLETE THE PROCEDURE AND REMOVE THE CLOT. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8344653 ↗
• MalfunctionJan 11, 2019Break; Break

  IT WAS REPORTED THAT PRIOR TO THE PROCEDURE, THE CATHETER HUB WAS BROKEN WHEN REMOVED FROM THE PACKAGING. THERE WERE NO CLINICAL CONSEQUENCES REPORTED DUE TO THIS EVENT. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8240722 ↗
• InjuryJan 10, 2019Break; Break

  IT WAS REPORTED THAT DURING THE PROCEDURE, RESISTANCE WAS ENCOUNTERED WHEN ADVANCING THE SUBJECT GUIDE CATHETER INTO THE PATIENT VESSEL AND THE CATHETER WAS FRACTURED 15 CM AWAY FROM THE HUB. THE PATIENT WAS TAKEN TO OPERATING ROOM TO REMOVE THE BROKEN PART OF THE CATHETER. THERE WAS ABOUT 3-4 HOURS SURGICAL DELAY REPORTED. THE VASCULAR SURGEON WAS ABLE TO REMOVE THE BROKEN PART OF THE CATHETER BY CUTTING DOWN THE FEMORAL ARTERY AND GENTLY GRASPING A NON-FRACTURED PORTION OF THE CATHETER AND SLIDING IT OUT OF THE VESSEL. THE PATIENT ARTERY IS HEALING. THE PHYSICIAN INDICATED THAT THE PATIENT APPEARED TO HAVE A PERVIOUS CLOSURE DEVICE USED NEAR THE AREA OF THE PUNCTURE. IT WAS PROBABLE THAT A STARCLOSE OR PERCLOSE VASCULAR CLOSURE DEVICE MIGHT HAVE BEEN USED TO CLOSE THE FEMORAL ARTERY FROM SOME OTHER PREVIOUS INTERVENTIONAL PROCEDURE IN THE PAST. THIS MAY HAVE CAUSED SOME SCARRED AREA THAT CHALLENGED THE SUBJECT GUIDE CATHETER AND PRESENTING AN OBSTACLE THAT IT GOT CAUGHT WHEN IT WAS ENTERING AND BEING REMOVED FROM THE BODY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8233666 ↗
• MalfunctionDec 27, 2018Break; Break

  IT WAS REPORTED THAT THE SUBJECT DEVICE WAS FRACTURED. THERE WERE NO REPORTED CLINICAL CONSEQUENCES TO THE PATIENT. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8201323 ↗
• MalfunctionDec 18, 2018Break; Break

  IT WAS REPORTED THAT THE CATHETER SHAFT WAS FOUND TO BE BROKEN WHEN THE PACKAGE WAS OPENED DURING PREPARATION FOR THE PROCEDURE. THERE WERE NO REPORTED CLINICAL CONSEQUENCES TO THE PATIENT.

  Patient problems: No Patient Involvement

  MAUDE report 8175032 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K172468, K193034. One submission often covers many models, so check the product and lot details in each record.

• Z-1708-2019 · Apr 18, 2019 · Terminated
  Stryker Neurovascular, AXS Infinity LS Plus Long Sheath, Rx Only, Sterile EO, USA Customer Service 855-91 NEURO (916-3876): a) REF: INC-11196-70, 70cm, b) REF: INC-11196-80, 80