APRO 70 Catheter APRO-70-132Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00850014025038), received between May 15, 2023 and Jan 25, 2024 — classified as 3 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Material Deformation” (2 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, 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.

• MalfunctionJan 25, 2024Burst Container or Vessel; Leak/Splash; Material Deformation; Physical Resistance/Sticking; Burst Container or Vessel; Leak/Splash; Material Deformation; Physical Resistance/Sticking

  ADDITIONAL INFORMATION WAS RECEIVED REPORTING THE PROCEDURE BEING PERFORMED WAS A THROMBECTOMY. THE PATIENT'S VESSEL TORTUOSITY WAS SEVERE. THE CAUSE OF THE CATHETER RUPTURE WAS UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18582130 ↗
• InjuryOct 19, 2023Collapse; Collapse

  ADDITIONAL INFORMATION WAS RECEIVED FROM THE MANUFACTURING REPRESENTATIVE (REP) STATING THAT THE CAUSE OF THE SOLITAIRE RESISTANCE AND APRO CATHETER COLLAPSING IS UNKNOWN.

  Patient problems: Ischemia Stroke

  MAUDE report 17969512 ↗
• InjuryOct 19, 2023Physical Resistance/Sticking; Physical Resistance/Sticking

  ADDITIONAL INFORMATION WAS RECEIVED FROM THE MANUFACTURING REPRESENTATIVE (REP) STATING THAT THE CAUSE OF THE SOLITAIRE RESISTANCE AND APRO CATHETER COLLAPSING IS UNKNOWN.

  Patient problems: Ischemia Stroke

  MAUDE report 17969477 ↗
• InjuryAug 8, 2023Material Deformation; Packaging Problem; Material Deformation; Packaging Problem

  MEDTRONIC RECEIVED A REPORT THAT THE APRO CATHETER WAS KINKED AT THE HUB. IT WAS REPORTED THAT THE NEURO TECH MENTIONED THAT THE CATHETER WAS KINKED AT THE HUB WHEN THEY REMOVED IT FROM THE PACKAGING AND STATED THAT THEY WERE ABLE TO SALVAGE IT BUT NOTED IT WOULD BE MORE USER FRIENDLY IF IT CAME IN A HOOP. THE ASPIRATION CATHETER WAS BENT AT 90 DEGREES AT THE JUNCTION OF THE CATHETER AND THE HUB ON THE PROXIMAL PORTION. THEY STRAIGHTENED IT OUT AND RESHAPED THE CATHETER AND IT "WORKED FINE". THE PRODUCT WAS DIFFICULT TO REMOVE FROM THE PACKAGING, AND MAY HAVE CONTRIBUTED TO THE ISSUE. THE DOC WENT AHEAD WITH THE APRO, AND IT TRACKED FINE TO THE LESION. HOWEVER, THEY WEREN'T ABLE TO ASPIRATE MUCH MATERIAL. CLOT MAY HAVE GONE DOWNSTREAM TO THE M2 TERRITORY. THEY OPENED A PENUMBRA 3MAX. THAT CLEARED SOME, BUT MORE CLOT CONTINUED TO GO DOWNSTREAM. AT THAT POINT, THE DOCTOR USED A MICROVENTION HEADWAY AND ADMINISTERED 10MG AGGRASTAT IA. PATIENT WAS REFERRED TO VASCULAR FOR AN ENDARTERECTOMY. THE APRO CATHETER WAS DISCARDED AND WILL NOT BE AVAILABLE FOR ANALYSIS AND PRODUCT INSPECTION.  THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF A LARGE VESSEL OCCLUSION (LVO) OF THE RIGHT INTERN

  Patient problems: Thromboembolism

  MAUDE report 17484052 ↗
• MalfunctionMay 15, 2023Break; Break

  ADDITIONAL INFORMATION WAS RECEIVED THAT IT APPEARED THAT THE STRAIN RELIEF WAS NOT SECURELY FASTENED TO THE CATHETER HUB. NO UNNECESSARY PUSHING OR PULLING OCCURRED DURING THE PROCEDURE/USE OF THE APRO THAT WOULD HAVE UNUSUALLY WEAKENED THE STRAIN RELIEF ITSELF.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16936123 ↗