AXS VECTA 71 INC-11129-115Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 07613327459210), received between Aug 21, 2019 and Mar 6, 2026 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Fracture” (4 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 6, 2026Fracture

  IT WAS REPORTED THAT DURING A PROCEDURE FOR A RIGHT POSTERIOR COMMUNICATING ARTERY ANEURYSM, A THROMBUS ASPIRATION SUBJECT CATHETER WAS INTENDED TO ESTABLISH ACCESS. DURING USE, THE PROXIMAL PART OF THE 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 24537306 ↗
• MalfunctionJul 19, 2024Fracture; Fracture

  IT WAS REPORTED THAT DURING RUPTURED ANEURYSM PROCEDURE, AFTER THE STENT WAS REMOVED FROM THE MICROCATHETER, THE LONG SHEATH HAD PROLAPSED AROUND THE ARCH AND THE SUBJECT INTERMEDIATE CATHETER WAS OBSERVED TO BE STILL IN PLACE IN THE ICA (INTERNAL CAROTID ARTERY). THE PHYSICIAN REMOVED THE LONG SHEATH, MICROCATHETER AND SUBJECT INTERMEDIATE CATHETER WHICH WAS OBSERVED TO BE UNRAVELLING DISTALLY. RESISTANCE WAS ENCOUNTERED REMOVING THE INTERMEDIATE CATHETER WHICH THEN UNRAVELED THE NITINOL ROUND WIRE COIL SEGMENT OF THE INTERMEDIATE CATHETER INTO THE LONG SHEATH. 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 19780313 ↗
• MalfunctionApr 3, 2023Fracture; Fracture

  IT WAS REPORTED WHEN THE PROCEDURE WAS COMPLETED AND REMOVAL OF THE CATHETER (SUBJECT DEVICE) FROM THE PATIENT ANATOMY, SUBJECT CATHETER WAS FRAYED AND HAS STRINGS FALLING OFF. THERE WERE NO CLINICAL CONSEQUENCES WERE REPORTED TO THE PATIENT DUE TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16662928 ↗
• MalfunctionJul 28, 2020Fracture; Fracture

  IT WAS REPORTED THAT DURING A THROMBECTOMY PROCEDURE IN VERY TORTUOUS ANATOMY, RESISTANCE WAS ENCOUNTERED IN THE INTERNAL CAROTID ARTERY AND THE PROXIMAL PART OF THE SUBJECT CATHETER FRACTURED DURING USE. THE PHYSICIAN COMPLETELY AND SUCCESSFULLY REMOVED THE FRACTURED CATHETER BY HAND. THE PROCEDURE WAS COMPLETED USING ANOTHER DISTAL ACCESS CATHETER. NO CLINICAL CONSEQUENCES WERE REPORTED TO THE PATIENT DUE TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 10336296 ↗
• MalfunctionAug 21, 2019Break; Break

  IT WAS REPORTED THAT DURING COMBINATION THROMBECTOMY PULL, THE SUBJECT DEVICE CATHETER WAS FRACTURED AT THE PROXIMAL AND IT APPEARS TO ALSO HAVE UNRAVELED. ALL PIECES WERE SUCCESSFULLY REMOVED, AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH OTHER DISTAL ACCESS CATHETER PRODUCTS. THERE WERE NO CLINICAL CONSEQUENCES TO THE PATIENT DUE TO THE REPORTED EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8919119 ↗

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