072 Aspiration System FG 00806Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00857545008097), received between Jun 21, 2024 and Jan 31, 2025 — classified as 2 injuries, 1 malfunction.

The most frequently reported specific device problem is “Use of Device Problem” (3 reports).

1 FDA recall record name this device's identifier, 1 still open.

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. How this data works · Data updated Oct 13, 2026.

Recalls naming this device

1. Feb 26, 2025Open, Classified

   Aspiration catheter distal tip features and characteristics may not be in the scope of FDA clearance; tip detachment, vessel rupture, and vasospasm could occur.

   Z-1512-2025 · Root cause: Device Design · FDA record ↗

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryJan 31, 2025Use of Device Problem; Use of Device Problem

  RETROSPECTIVE FILING FOR AN EVENT THAT OCURED 5/2/2024. THE CASE WAS REPORTED BY Q'APEL MEDICAL'S CHIEF MARKETING OFFICER WHO WAS PRESENT FOR THE CASE AND REPORTED THE FINDINGS. THE INITIAL REVIEW BY Q'APEL MEDICAL'S MEDICAL PHYSICAN AND "QUALIFIED PERSON" DETERMINED THAT THE Q'APEL DEVICE DID NOT CONTRIBUTE TO THE INJURY AND THEREFORE, THE EVENT WAS NOT REPORTABLE. NEW INFORMATION WAS OBTAINED BY Q'APEL MEDICAL FROM THE OPERATOR OF THE DEVICE ON 1/15/2025 WHICH STATED: "THERE IS NO FLUORO LOOP OF THE 2ND PASS HIPPO NAVIGATING UP TO THE CLOT. THERE IS ONE OF THE FIRST PASS AND IT NAVIGATED SMOOTHLY WITH NO WIRE ISSUES. I CAN NOT IMAGINE HOW THAT AMOUNT OF EXTRAVASATION OCCURRED FROM A MICROWIRE PERFORATION. " THE NEW INFORMATION CONCLUDED THAT THE Q'APEL MEDICAL DEVICE LIKELY CONTRINUTED TO THE INJURY THAT REQUIRED MEDICAL INTERVENTION. CASE DATE:(B)(6) 2024. 78 YO [YEAR OLD] FEMALE PATIENT. STROKE CASE R M1 OCCLUSION. 3.5 SINCE LKW. NO TNK OR TPA ADMINISTERED DUE TO A FALL. WALRUS BGC USED AS GUIDE. 1 PASS WITH HIPPO CHEEATH WITH AN ARISTOTLE 18 GW. RESULT WAS TICI 0. 2ND PASS WITH HIPPO CHEETAH AND ARISTOTLE 18 GW. ON RUN POST ASPIRATION, VESSEL RUPTURE WITH CONTRAST EXTRAVASATIO

  Patient problems: Extravasation; Hemorrhage/Blood Loss/Bleeding

  MAUDE report 21284855 ↗
• InjuryJan 31, 2025Use of Device Problem; Use of Device Problem

  RETROSPECTIVE FILING FOR AN EVENT THAT OCCURRED 12/31/2023. INFORMATION WAS OBTAINED WHILE REVIEWING DATA FROM Q'APEL' S RETROSPECTIVE COHORT STUDY WITH HIPPO. FOLLOW UP INFORMATION WAS OBTAINED BY Q'APEL MEDICAL FROM THE OPERATOR OF THE DEVICE ON 1/16/2025 WHICH STATED: "HIPPO ADVANCED TO M1 FOR THROMBECTOMY AND FOLLOW UP RUN SHOWS VASOSPASM. I REVIEWED IMAGING. AFTER 1ST PASS THERE IS MINIMAL VASOSPASM I WOULD HAVE TO SAY LIKELY CAUSED BY HIPPO (VASOSPASM I DONT THINK IT WAS CLINICALLY SIGNIFICANT IN REVIEW HOWEVER THE OPERATOR ADMINISTERED 8 MG VERAPAMIL TO TREAT THE VASOSPASM. FINAL TICI SCORE WAS 2C". VESSULE OCCLUDED-LMCA M1, FIRST PASS TICI SCORE-0, FINAL PASS TICI SCORE-2C. REPORTED DEVICES INVOLVED IN THE PROCEDURE: ZOOM 88, HIPPO, ZOOM 71, ZOOM 35, ZOOM POD.

  Patient problems: Vasoconstriction

  MAUDE report 21284834 ↗
• MalfunctionJun 21, 2024Use of Device Problem; Compatibility Problem; Use of Device Problem; Compatibility Problem

  ASPIRATION SYSTEM (HIPPO) WAS BEING REMOVED/BACKED OUT OF THE ZOOM RDL FOLLOWING ASPIRATION. DR (B)(6) ATTEMPTED TO PASS A ZOOM 71 THROUGH THE ZOOM RDL ON A SECOND PASS AND IT WOULD NOT ADVANCE THROUGH. THE ZOOM RDL AND ZOOM 71 WERE THEN COMPLETELY REMOVED FROM THE BODY IN WHICH IT WAS DISCOVERED THAT THERE WAS A PIECE OF THE HIPPO INSIDE THE RDL TOWARDS THE DISTAL TIP. NO PART OF THE HIPPO TIP REMAINED IN THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19583959 ↗