AXS VECTA 71 INC-11129-132Recalls & reported problems

Summary

The FDA's MAUDE database contains 44 adverse event reports that list this exact device (DI 07613327459234), received between Oct 10, 2018 and Jul 23, 2024 — classified as 1 injury, 43 malfunctions.

The most frequently reported specific device problem is “Break” (25 reports).

1 other recall cover devices cleared under the same FDA submission (K172167, 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 25 most recent of 44 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 23, 2024Fracture; Fracture

  IT WAS REPORTED THAT DURING LEFT MIDDLE CEREBRAL ARTERY INFARCTION PROCEDURE, THE DISTAL TIP OF THE SUBJECT CATHETER WAS BROKEN OFF. THE SUBJECT CATHETER WAS REMOVED FROM THE PATIENT ANATOMY. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO CLINICAL CONSEQUENCES WERE REPORTED TO THE PATIENT DUE TO THIS EVENT. THE SUBJECT CATHETER WAS RETURNED FOR ANALYSIS. THE CATHETER WAS EXAMINED, AND IT WAS DISCOVERED THAT THE REPORTED EVENT OF THE SUBJECT CATHETER TIP BEING BROKEN/FRACTURED DURING USE WAS NOT CONFIRMED. THE SUBJECT CATHETER TIP AND HUB WAS FOUND TO BE INTACT; THE SHAFT OF SUBJECT CATHETER WAS FOUND KINKED/BENT. THE SUBJECT SCOUT CATHETER TIP WAS NOTED TO BE BROKEN/FRACTURED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19810366 ↗
• MalfunctionFeb 14, 2024Fracture; Fracture

  IT WAS REPORTED THAT DURING THE PROCEDURE THE SUBJECT CATHETER WOULD NOT ADVANCE AND GOT BROKEN/FRACTURED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO CLINICAL CONSEQUENCES WERE REPORTED TO THE PATIENT DUE TO THIS EVENT. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18707897 ↗
• MalfunctionDec 18, 2023Fracture; Fracture

  IT WAS REPORTED THAT DURING ISCHEMIC STROKE PROCEDURE THE SUBJECT CATHETER FRACTURED. 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 18344053 ↗
• MalfunctionNov 24, 2023Fracture; Material Puncture/Hole; Fracture; Material Puncture/Hole

  IT WAS REPORTED THAT DURING A THROMBUS RETRIEVAL PROCEDURE, WHILE ATTEMPTING TO GUIDE THE SUBJECT INTERMEDIATE CATHETER WITH MICROCATHETER AND GUIDEWIRE, RESISTANCE WAS ENCOUNTERED. IT WAS SEEN THAT GUIDEWIRE WAS ABLE TO ADVANCE BUT MICROCATHETER WAS STUCK IN SUBJECT INTERMEDIATE CATHETER. WHEN TRIED WITH DIFFERENT GUIDEWIRE, IT DEVIATED FROM THE TIP OF SUBJECT INTERMEDIATE CATHETER. OPERATOR REMOVED THE SUBJECT INTERMEDIATE CATHETER AND ITS SHAFT WAS FOUND BROKEN AND PERFORATED. THE OPERATOR 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 18203405 ↗
• MalfunctionOct 17, 2023Fracture; Fracture

  IT WAS REPORTED THAT DURING THE THROMBECTOMY PROCEDURE THE SUBJECT CATHETER WAS USED TO RETRIEVE THE CLOT. DURING RETRIEVAL WHILE THE PHYSICIAN WAS PULLING THE SUBJECT CATHETER BACK, THE TIP OF THE SUBJECT CATHETER WASN¿T MOVING AS IT GOT FRACTURED AND UNRAVELED. PATIENT¿S ANATOMY HAD AVERAGE TORTUOSITY. 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 17950810 ↗
• MalfunctionMar 14, 2023Fracture; Fracture

  ANALYSIS OF THE RETURNED DEVICE FOUND THAT THE SUBJECT CATHETER SHAFT WAS BROKEN/FRACTURED DURING USE. THERE WERE NO CLINICAL CONSEQUENCES TO THE PATIENT REPORTED AS A RESULT OF THIS EVENT AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16537047 ↗
• MalfunctionJan 31, 2023Peeled/Delaminated; Peeled/Delaminated

  IT WAS REPORTED THAT AFTER SUCCESSFUL COMPLETION OF THE PROCEDURE WHEN THE SUBJECT CATHETER WAS STORED IN A TRAY , SOMETHING LIKE COATING SUBSTANCE WAS FOUND FLOATING IN THE SALINE SOLUTION IN THE TRAY. IT IS UNCLEAR AT WHAT POINT IN TIME THIS OCCURRED. NO CLINICAL CONSEQUENCES WERE REPORTED TO THE PATIENT DUE TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16270013 ↗
• MalfunctionDec 14, 2021Fracture; Fracture

  IT WAS REPORTED THAT DURING THE PROCEDURE, THE CATHETER (SUBJECT DEVICE) FRACTURED AT THE DISTAL END DURING RETRACTION FROM THE PATIENT. THE CATHETER WAS ALSO FOUND TO BE STRETCHED AT THE DISTAL END. 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 13003230 ↗
• MalfunctionAug 6, 2021Fracture; Fracture

  THE SUBJECT CATHETER WAS RETURNED FOR ANALYSIS AND THE DEVICE INVESTIGATION REVEALED THAT THE CATHETER SHAFT WAS BROKEN/FRACTURED DURING USE. NO CLINICAL CONSEQUENCES WERE REPORTED TO THE PATIENT DUE TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12291689 ↗
• MalfunctionAug 6, 2021Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT THE SUBJECT CATHETER WAS USED FOR STROKE PROCEDURE. DURING THE PROCEDURE, IT WAS DISCOVERED THE SUBJECT CATHETER WAS LEAKING OUT OF BLOOD FROM THE DISTAL OF THE CATHETER AND COULD NOT GET ENOUGH SUCTION. THE PROCEDURE WENT WELL WITH COMPLETE REPERFUSION AND PATIENT WAS NOT HURT. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12291514 ↗
• MalfunctionMay 28, 2021Fracture; Fracture

  IT WAS REPORTED THAT DURING THE THROMBUS ASPIRATION PROCEDURE RESISTANCE WAS ENCOUNTERED WHILE ATTEMPTING TO REMOVE ASPIRATION CATHETER (SUBJECT DEVICE), RESULTING IN THE DISTAL PORTION BEING FRACTURED. THE FRACTURED SEGMENT WAS ABLE TO BE REMOVED FROM THE GUIDE-SHEATH SUCCESSFULLY. THE CATHETER WAS REPLACED AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THE PATIENTS MEDICAL CONDITION WAS GOOD AND THERE WERE NO CLINICAL CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11903929 ↗
• MalfunctionApr 6, 2021Peeled/Delaminated; Peeled/Delaminated

  IT WAS REPORTED THAT DURING THE PROCEDURE, THE CATHETER (SUBJECT DEVICE) INNER PTFE LINING AT THE DISTAL PORTION WAS FOUND DELAMINATING. THE PHYSICIAN COMPLETED THE PROCEDURE WITHOUT CLINICAL CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11619908 ↗
• MalfunctionJan 31, 2020Fracture; Fracture

  IT WAS REPORTED THAT DURING A STROKE INTERVENTION CASE, THE ASPIRATION CATHETER(SUBJECT DEVICE) WAS ATTEMPTED TO REACH A CLOT LOCATED IN THE MCA (MIDDLE CEREBRAL ARTERY (M1) SEGMENT BUT WAS NOT ABLE TO THE REACH THE CLOT. THE DEVICE WAS REMOVED FROM THE PATIENT'S BODY AND WAS FOUND TO BE FRACTURED APPROXIMATELY 12CM FROM THE DISTAL TIP. THE PHYSICIAN REPLACED IT WITH A ANOTHER BRAND CATHETER AND THE CLOT WAS REMOVED,COMPLETING THE PROCEDURE WITHOUT ANY CLINICAL CONSEQUENCES TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9654845 ↗
• MalfunctionNov 20, 2019Fracture; Fracture

  IT WAS REPORTED THAT AFTER THE FIRST PASS WITH CATHETER WHILE ATTEMPTING TO DISCONNECT THE TUBING FROM CATHETER THE CATHETER BROKE AT THE HUB. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THE PATIENTS MEDICAL CONDITION WAS GOOD. NO CLINICAL CONSEQUENCES WERE REPORTED TO THE PATIENT DUE TO THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9351164 ↗
• MalfunctionNov 14, 2019Fracture; Fracture

  ANALYSIS OF THE RETURNED DEVICE NOTED THAT THE CATHETER SHAFT WAS BROKEN. NO CONSEQUENCES TO THE PATIENT WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9325107 ↗
• MalfunctionOct 15, 2019Break; Break

  IT WAS REPORTED THAT FRICTION WAS EXPERIENCED WHILE INSERTING THE INTERMEDIATE CATHETER(SUBJECT DEVICE) INTO THE GUIDE CATHETER AND THE SUBJECT INTERMEDIATE CATHETER WAS BROKEN FROM THE PROXIMAL END AFTER BEING INSERTED INTO THE GUIDE CATHETER. THERE WERE NO REPORTED CLINICAL CONSEQUENCES TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient; No Known Impact Or Consequence To Patient

  MAUDE report 9192415 ↗
• MalfunctionJul 17, 2019Break; Break

  IT WAS REPORTED THAT THE ASPIRATION CATHETER WAS FRACTURED AT THE HUB. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH NO CLINICAL CONSEQUENCES TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8800172 ↗
• MalfunctionJul 17, 2019Break; Break

  IT WAS REPORTED THAT DURING A THROMBECTOMY PROCEDURE, THE SUBJECT CATHETER FRACTURED ON THE PROXIMAL END. THE PHYSICIAN REPLACED IT WITH A NEW CATHETER AND CONTINUED THE PROCEDURE WITHOUT CLINICAL CONSEQUENCES TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8799927 ↗
• MalfunctionJun 27, 2019Break; Break

  IT WAS REPORTED THAT DURING ACUTE ISCHEMIC STROKE THROMBECTOMY PROCEDURE, WHILE INSERTING THE CATHETER (SUBJECT DEVICE) THROUGH A LONG SHEATH, THE SUBJECT DEVICE BROKE AT THE MOST PROXIMAL SECTION. THERE WERE NO CLINICAL CONSEQUENCES TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8742468 ↗
• MalfunctionJun 21, 2019Break; Break

  IT WAS REPORTED THAT DURING PROCEDURE, THE SUBJECT DEVICE WAS FRACTURED FROM THE PROXIMAL TO THE HUB. THERE WERE NO CLINICAL CONSEQUENCES TO THE PATIENT DUE TO THE REPORTED EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8724484 ↗
• InjuryJun 6, 2019Fracture; Fracture

  IT WAS REPORTED THAT DURING A THROMBECTOMY PROCEDURE, THERE WAS A CATHETER (SUBJECT DEVICE) KINK THAT CAUSED FRACTURE OF THE DISTAL SEGMENT. THE PHYSICIAN HAD TO SNARE THE BROKEN CATHETER AND PULL IT OUT OF THE PATIENT. ACCORDING TO THE PHYSICIAN, THE BREAK WAS CAUSED BY A DIFFICULT ANATOMY. THERE WERE NO CLINICAL CONSEQUENCES TO THE PATIENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8676935 ↗
• MalfunctionJun 6, 2019Fracture; Fracture

  ANALYSIS OF THE INVESTIGATION FOUND THAT THE DAC SHAFT WAS BROKEN/FRACTURED. THERE WERE NO CLINICAL CONSEQUENCES TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8676929 ↗
• MalfunctionJun 3, 2019Break; Break

  DURING A CASE, THE CATHETER (SUBJECT DEVICE) CRACKED AT THE PROXIMAL END. THERE WERE NO CLINICAL CONSEQUENCES TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8664418 ↗
• MalfunctionMay 28, 2019Fracture; Fracture

  IT WAS REPORTED THAT THE SUBJECT DEVICE PROXIMAL SHAFT WAS BROKEN DURING THE THROMBECTOMY. 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 8647017 ↗
• MalfunctionMay 20, 2019Break; Break

  IT WAS REPORTED THAT DURING THE THROMBECTOMY PROCEDURE, THE SUBJECT CATHETER WAS ADVANCED INTO PATIENT BUT NOT TO SITE OF OCCLUSION; THEREFORE; IT WAS REMOVED. A SECOND ATTEMPT WAS MADE TO INSERT THE SUBJECT CATHETER INTO THE PATIENT AND AT THAT TIME THE SUBJECT CATHETER WAS BROKEN NEAR THE HUB. THE PHYSICIAN REPLACED IT WITH A NEW CATHETER AND CONTINUED THE PROCEDURE WITHOUT CLINICAL CONSEQUENCES TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8625187 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K172167, K190212, K190833, K191768, K200206. One submission often covers many models, so check the product and lot details in each record.

• Z-1620-2020 · Apr 10, 2019 · Terminated
  Stryker Neurovascular, AXS Vecta 71 Aspiration Catheter, Ref. Catalog No. INC-11129-115, Use By 2021-11-29, Rx Only, Sterile/EO, Manufactured For: Stryker Neurovascular 47900 Baysi