072 Aspiration SystemRecalls & reported problems across all models
Q'Apel Medical LLC · 3 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
1 open recall names at least one 072 Aspiration System model. Check whether yours is affected in the recall details, and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls
- 1
We found 3 models of 072 Aspiration System by Q'Apel Medical LLC in the FDA's device registry (GUDID). Together they are named in 3 adverse event reports in the FDA's MAUDE database, 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 at least one of these models by its device 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
072 Aspiration System recalls
FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.
- 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 · names 3 of these models · Recall details · FDA record ↗
Most reported 072 Aspiration System problems
Device problems
- Use of Device Problem3
- Compatibility Problem1
Patient problems
- Extravasation1
- Hemorrhage/Blood Loss/Bleeding1
- No Clinical Signs, Symptoms or Conditions1
- Vasoconstriction1
072 Aspiration System models
3 models, most reported first. Each model has its own page with its reports, recalls and device details.
- 072 Aspiration System FG 00806Catheter, Thrombus Retriever1 recall3 reports
- 072 Aspiration System FG 00995Catheter, Thrombus Retriever1 recall0 reports
- 072 Aspiration System FG 01252Catheter, Thrombus Retriever1 recall0 reports
Recent 072 Aspiration System adverse event reports
The 3 most recent reports across all models, 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 ↗
Other Q'Apel Medical LLC products
All Q'Apel Medical LLC devices →Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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