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Heli-FX™ EndoAnchor™ System SG-64 (UDI 00763000006624)Recalls & reported problems

Medtronic, Inc. · AAA GUIDE DEVICE 22 EIFU · Class 2 · Implant

Adverse event reports
1
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00763000006624), received between Oct 23, 2017 and Oct 23, 2017 — classified as 1 malfunction.

The most frequently reported specific device problem is “Leak/Splash” (1 report).

1 other recall cover devices cleared under the same FDA submission (K171427, K182957); 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Device problems

  • Leak/Splash1

Patient problems

  • No Consequences Or Impact To Patient1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

  • MalfunctionOct 23, 2017Leak/Splash; Leak/Splash

    HELI-FX APTUS ENDOANCHORS WERE IMPLANTED IN A PATIENT FOR THE TREATMENT FOR PREVENTION OF AORTIC NECK DILATATION IN ANOTHER MANUFACTURER¿S STENT GRAFT. IT WAS REPORTED THE FINAL ANGIOGRAM REVEALED A PROXIMAL TYPE I ENDOLEAK, A LOW-FLOW PROXIMAL TYPE I ENDOLEAK. THERE WAS NO INTERVENTION PERFORMED AND THE PROXIMAL TYPE I ENDOLEAK WAS UNRESOLVED. PER THE INVESTIGATOR THE IMPLANTATION OF THE HELI-FX APTUS ENDOANCHORS WAS NOT SUCCESSFUL. THE INVESTIGATOR INDICATED THE CAUSE OF THE EVENT WAS RELATED TO THE AAA. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT WILL BE MONITORED BY THE PHYSICIAN.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 6968579 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K171427, K182957. One submission often covers many models, so check the product and lot details in each record.

  • Z-3227-2017 · Sep 13, 2017 · Terminated
    Medtronic Aptus Heli-FX Thoracic EndoAnchor System Heli-FX Guide 42 mm, REF HG-18-90-42, STERILE EO, Rx Only The Heli-FX EndoAnchor System is intended to provide fixation and sea

Other Endovascular suturing system devices

All Endovascular suturing system devices →

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.