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Heli-FX™ EndoAnchor™ System HG-18-90-22Recalls & reported problems

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

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

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00763000006655), received between Sep 22, 2017 and Sep 22, 2017 — classified as 1 malfunction.

The most frequently reported specific device problem is “Device Markings/Labelling Problem” (1 report).

1 FDA recall record name this device's identifier.

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. Sep 13, 2017Terminated

    It was determined that the deflection length indicated on the Guide catheter handle does not match the label on the box and sterile packaging for two lots.

    Z-3227-2017 · Root cause: Labeling Change Control · FDA record ↗

Most reported problems

Device problems

  • Device Markings/Labelling Problem1

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.

  • MalfunctionSep 22, 2017Device Markings/Labelling Problem; Device Markings/Labelling Problem

    A HELI-FX GUIDE CATHETER WAS INSERTED INTO A PATIENT PROPHYLACTICALLY DURING THE IMPLANT OF A VALIANT STENT GRAFT SYSTEM IN THE THORACIC AORTA. IT WAS REPORTED THAT THE PHYSICIAN OPENED THE PACKAGE FOR HELI-FX GUIDE CATHETER AND NOTED THAT LABEL ON THE BOX AND STERILE PACKAGING WAS LABELLED AS THORACIC HG-18-90-22MM HOWEVER THE HELI-FX DEVICE CATHETER LABEL WAS 42MM. THE PHYSICIAN ELECTED TO USE THE DEVICE EVEN THOUGH THE LABELLING WAS DIFFERENT. IT WAS OBSERVED THAT THE DEVICE WOULD NOT DEFLECT AS MUCH AS THE PHYSICIAN INTENDED HOWEVER PHYSICIAN DID MANAGE TO PLACE A FEW OF THE HELI-FX APTUS ENDOANCHORS. A SECOND THORACIC HG-18-90-22MM, ALSO FROM THE SALES REP¿S TRUNK STOCK, WITH THE SAME LOT NUMBER WAS OPENED. HOWEVER, THE SAME LABELING ISSUE WAS ON THE DEVICE AND THE PHYSICIAN ELECTED TO NOT USE THIS DEVICE. THE HOSPITAL HAD A HELI-FX APTUS ABDOMINAL GUIDE (SG-64) 22MM AND THE PHYSICIAN WAS ABLE TO USE THIS DEVICE TO COMPLETE DEPLOYMENT OF THE HELI-FX APTUS ENDOANCHORS. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS FINE.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 6885698 ↗

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