AXS VECTA 74 INC-11597-132Recalls & reported problems

Summary

The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 07613327459265), received between Mar 26, 2019 and Mar 30, 2026 — classified as 4 injuries, 11 malfunctions.

The most frequently reported specific device problem is “Fracture” (12 reports).

1 other recall cover devices cleared under the same FDA submission (K181354, K190212, K190833, K191768, K200206); 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 15 most recent of 15 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 30, 2026Fracture

  IT WAS REPORTED THAT THE SUBJECT CATHETER SHAFT BROKE WHILE INTRODUCING INTO BODY. NO FURTHER INFORMATION WAS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24730141 ↗
• InjuryMay 29, 2023Fracture; Fracture

  IT WAS REPORTED THAT DURING THE PROCEDURE THE OPERATOR ATTEMPTED TO ADVANCE THE MICROCATHETER AND MICRO WIRE THROUGH THE SUBJECT CATHETER BUT RESISTANCE WAS FELT. WHEN THE OPERATOR ATTEMPTED TO REMOVE THE SUBJECT CATHETER, MORE RESISTANCE WAS ENCOUNTERED. THE OPERATOR PULLED AND THE SUBJECT CATHETER CAME OUT. HOWEVER, THE SUBJECT CATHETER WAS BROKEN AND THERE WAS COIL HANGING FROM THE CATHETER. THE MARKER BAND AND SIGNIFICANT PORTION OF THE DISTAL SUBJECT CATHETER REMAINED INSIDE THE PATIENT'S ARTERY. THE PHYSICIAN USED A CATHETER, RETRIEVER DEVICE AND SNARE TO ATTEMPT TO REMOVE THE BROKEN PART OF THE CATHETER BUT WAS UNSUCCESSFUL. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: Foreign Body In Patient

  MAUDE report 17017040 ↗
• MalfunctionSep 22, 2022Fracture; Fracture

  IT WAS REPORTED DURING ASPIRATION WITH THE PUMP WHEN THE SUBJECT CATHETER WAS RETRACTED, THERE WAS SEVERE RESISTANCE. AFTER REMOVING THE CATHETER FROM THE PATIENT, THE TIP OF THE DEVICE WAS FOUND FRACTURED. THE DEVICE WAS REPLACED AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO CLINICAL CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15468664 ↗
• MalfunctionJun 2, 2022Fracture; Fracture

  THE DEVICE WAS RETURNED FOR ANALYSIS AND THE INVESTIGATION OF THE DEVICE REVEALED THAT THE CATHETER (SUBJECT DEVICE) SHAFT WAS FRACTURED DURING USE ON THE PATIENT. NO CLINICAL CONSEQUENCES WERE REPORTED TO THE PATIENT DUE TO THIS EVENT. NO OTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14575471 ↗
• MalfunctionMar 24, 2022Fracture; Deformation Due to Compressive Stress; Fracture; Deformation Due to Compressive Stress

  IT WAS REPORTED THAT THE SUBJECT CATHETER BROKE INTO TWO HALVES WHEN THE TECHNICIAN WENT TO PREPARE IT FOR A PROCEDURE. UPON REQUEST FOR ADDITIONAL INFORMATION, A PICTURE WAS RECEIVED ON 25-FEB-2022 FROM THE CUSTOMER WHICH SHOWS PROCEDURAL FLUIDS ON THE SUBJECT CATHETER HUB AND ON THE HOOP INDICATING THAT THE SUBJECT CATHETER MIGHT HAVE BROKEN DURING USE IN THE PROCEDURE. IT IS UNCLEAR WHETHER REPORTED ISSUE OCCURRED DURING PREPARATION OR DURING PROCEDURE. NO ADDITIONAL INFORMATION IS AVAILABLE. 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 13895382 ↗
• MalfunctionMar 17, 2022Fracture; Fracture

  ANALYSIS OF THE RETURNED DEVICE FOUND THAT THE SUBJECT CATHETER SHAFT BROKEN/FRACTURED DURING USE. 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 13795944 ↗
• InjurySep 8, 2021Fracture; Fracture

  IT WAS REPORTED THAT DURING THE PROCEDURE, THE SUBJECT ASPIRATION CATHETER DISTAL TIP WAS BROKEN. THE PHYSICIAN USED A SNARE DEVICE TO REMOVE THE BROKEN PART OF THE CATHETER FROM THE PATIENT¿S ANATOMY. ANOTHER ASPIRATION CATHETER TO WAS USED TO COMPLETE THE PROCEDURE SUCCESSFULLY. 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 12437319 ↗
• MalfunctionJun 8, 2021Fracture; Fracture

  IT WAS REPORTED THAT ASPIRATION THROMBECTOMY PROCEDURE WAS PERFORMED FOR MCA (MIDDLE CEREBRAL ARTERY) STROKE (M1 SEGMENT OCCLUSION). ASPIRATION WAS PERFORMED WITH ASPIRATION CATHETER AND PUMP DURING THE FIRST PASS. WHEN THE PHYSICIAN TRIED TO WITHDRAW THE SUBJECT CATHETER, RESISTANCE WAS ENCOUNTERED, AND IT WAS UNABLE TO BE REMOVED. PHYSICIAN NOTED THAT THE SUBJECT CATHETER WOULD NOT COME OUT AS USUAL AND THE ONLY WAY TO REMOVE IT WAS WITH SIGNIFICANT FORCE. AFTER CONTINUING TO PULL ON THE HUB OF THE SUBJECT CATHETER, IT GOT RELEASED AND CAME OUT OF THE PROXIMAL END OF THE ACCESS GUIDE SHEATH, WITH ITS MID-SECTION FRACTURED AND UNRAVELED, AS ONLY THE COIL CAME OUT. THE SUBJECT CATHETER WAS STUCK, AND THE TIP OF THE SUBJECT CATHETER WAS LODGED INSIDE THE ACCESS GUIDE SHEATH. PHYSICIAN REMOVED ACCESS GUIDE SHEATH AND SUBJECT CATHETER FROM THE PATIENT ANATOMY. THE CLOT WAS REMOVED IN THE PROCESS OF REMOVING BOTH THE ACCESS GUIDE SHEATH AND SUBJECT CATHETER. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO CLINICAL CONSEQUENCES WERE REPORTED TO THE PATIENT DUE TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11962989 ↗
• MalfunctionMay 4, 2021Fracture; Fracture

  IT WAS REPORTED THAT WHILE PERFORMING A THROMBECTOMY FOR A STROKE IN THE MIDDLE CEREBRAL ARTERY (MCA), THE PHYSICIAN ENCOUNTERED DIFFICULTY REMOVING THE SUBJECT CATHETER AFTER PERFORMING THE FIRST PASS ASPIRATION AND HAD TO USE SIGNIFICANT FORCE TO REMOVE IT. THE SUBJECT CATHETER STRETCHED AND FRACTURED NEAR THE MIDSHAFT TO DISTAL END. PATIENT ANATOMY WAS REPORTED AS FAIRLY TORTUOUS. THE CATHETER WAS REMOVED SUCCESSFULLY FROM THE PATIENT AND REPLACED WITH A SIMILAR DEVICE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO CLINICAL CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11770340 ↗
• InjuryMar 12, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THROMBECTOMY PROCEDURE WAS PERFORMED USING TWO VECTA 74 CATHETERS ALONG WITH OTHER DEVICES TO REMOVE THE THROMBUS/CLOTS IN PATIENTS EXPERIENCING ISCHEMIC STROKE. PRIOR PROCEDURE, THE PATIENT NEUROLOGICAL ASSESSMENT SHOWED TICI (THROMBOLYSIS IN CEREBRAL INFARCTION SCORE) OF 0, NATIONAL INSTITUTE OF HEALTH STROKE SCALE (NIHSS) OF 15 AND MRS (MODIFIED RANKIN SCORE) OF 0. THE FIRST VECTA 74 CATHETER DEVICE WAS USED AT THE FIRST PASS AND THE ASPIRATION OF CLOT WAS PERFORMED SUCCESSFULLY. UPON WITHDRAWING THE FIRST VECTA 74 CATHETER, IT WAS NOTED TO BE STUCK IN THE LONG SHEATH INFINITY DEVICE AND FOR THIS REASON THE ENTIRE SYSTEM INCLUDING THE VECTA 74 CATHETER AND THE GUIDE CATHETER WERE REMOVED. THE FIRST VECTA 74 CATHETER WAS NOTED TO BE STRETCHED AND UNCOILED PARTIALLY. AFTER RE-SELECTING THE RIGHT INTERNAL CAROTID ARTERY, THE FRESH SECOND SUBJECT VECTA 74 CATHETER ALONG WITH OTHER DEVICES WERE USED FOR THE SECOND PASS. DUE TO SMALL SIZE OF THE TARGET THE SUBJECT VECTA 74 CATHETER WAS UNABLE TO BE PLACED PAST THE OCCLUSION AND THUS THE ASPIRATION WAS PERFORMED VIA THE 3MAX CATHETER AT THE M2-3 DIVISION/BIFURCATION. CONTROL ANGIOGRAPHY WAS PERFORMED WHICH DEMONSTR

  Patient problems: Aneurysm; Dysphasia; Hemorrhage/Blood Loss/Bleeding; Hydrocephalus; Perforation of Vessels; Pseudoaneurysm; Restenosis; Vasoconstriction

  MAUDE report 11478201 ↗
• MalfunctionMar 8, 2021Fracture; Fracture

  IT WAS REPORTED THAT DURING THE PROCEDURE, THE CATHETER (SUBJECT DEVICE) ENCOUNTERED RESISTANCE AND WHEN PULLED BACK IT BROKE BETWEEN THE 5 - 7" MARK ON THE DISTAL TIP. MEDICAL DELAY OF UNKNOWN DURATION WAS REPORTED. NO MEDICAL INTERVENTION OR ADVERSE EVENTS WERE REPORTED TO THE PATIENT DUE TO THIS EVENT. PROCEDURE WAS REPORTED TO HAVE BEEN COMPLETED WITH A SIMILAR REPLACEMENT DEVICE. NO OTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11440277 ↗
• InjuryMar 8, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A DIRECT ASPIRATION PROCEDURE FOR ACUTE ISCHEMIC STROKE SECONDARY TO INTRACRANIAL LARGE VESSEL OCCLUSIVE DISEASE WAS DONE IN THE M1 VASCULAR SEGMENT. PATIENT WAS REPORTED TO HAVE MILD VASCULAR TORTUOSITY. AFTER REVASCULARIZATION WAS ESTABLISHED FOR M1 OCCLUSION, THE PHYSICIAN NOTICED AN M2 OCCLUSION. A REPERFUSION CATHETER WAS USED FOR ASPIRATION AND IT WAS ADVANCED THROUGH THE SUBJECT INTERMEDIATE CATHETER. WHEN THE PHYSICIAN PULLED THE REPERFUSION CATHETER PROXIMALLY TO REMOVE IT FROM THE M2 AFTER THE FIRST PASS, THE SUBJECT INTERMEDIATE CATHETER WENT DISTALLY INTO THE M2 AND VESSEL RUPTURE OCCURRED. A BALLOON WAS USED AS INTERVENTION TO ALLOW THE VESSEL TO HEAL. FOLLOWING THE M2 SEGMENT VESSEL RUPTURE, A SUBARACHNOID HEMORRHAGE WAS NOTED. HEMICRANIECTOMY WAS PERFORMED AND THE PATIENT WAS REPORTED TO HAVE GONE TO THE ICU. NO OTHER INFORMATION IS AVAILABLE.

  Patient problems: Intracranial Hemorrhage; Rupture

  MAUDE report 11438303 ↗
• MalfunctionJun 19, 2020Fracture; Fracture

  IT WAS REPORTED THAT DURING THE PROCEDURE, THE PHYSICIAN ENCOUNTERED RESISTANCE WHILE ADVANCING THE SUBJECT CATHETER IN TORTUOUS ANATOMY. THE DISTAL PART OF SUBJECT CATHETER FRACTURED. 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 10176585 ↗
• MalfunctionMay 4, 2020Fracture; Fracture

  IT WAS REPORTED THAT DURING CAROTID OCCLUSION CASE, THE MIDDLE SHAFT SECTION OF THE CATHETER (SUBJECT DEVICE) BROKE DUE TO INTERACTION WITH A GUIDE CATHETER WHILE THE PHYSICIAN WAS WITHDRAWING THE SUBJECT CATHETER FROM THE PATIENT'S ANATOMY. ALL THE FRACTURED PARTS OF THE SUBJECT CATHETER WERE SUCCESSFULLY REMOVED FROM THE PATIENT¿S ANATOMY. THE PHYSICIAN USED ANOTHER CATHETER AND COMPLETED THE PROCEDURE SUCCESSFULLY. THERE WERE NO CLINICAL CONSEQUENCES WERE REPORTED TO THE PATIENT DUE TO THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10022690 ↗
• MalfunctionMar 26, 2019Break; Break

  IT WAS REPORTED THAT WHEN THE CATHETER WAS BROKEN NEAR THE HUB WHEN ADVANCED THROUGH THE PATIENT'S ANATOMY. ANOTHER CATHETER WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO CLINICAL CONSEQUENCES TO THE PATIENT AS A RESULT OF THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8454454 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K181354, K190212, K190833, K191768, K200206. One submission often covers many models, so check the product and lot details in each record.

• Z-1621-2020 · Apr 10, 2019 · Terminated
  Stryker Neurovascular, AXS Vecta 74 Aspiration Catheter, Ref. Catalog No. INC-11597-115, Use By 2021-11-29, Rx Only, Sterile/EO, Manufactured For: Stryker Neurovascular 47900 Baysi