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EXPORT® GEZ6200US7BRecalls & reported problems

Medtronic, Inc. · CATHETER GEZ6200US7B EXPORT STAND ALONE · Class 2

Adverse event reports
2
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00613994416148), received between Sep 23, 2019 and Nov 20, 2019 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Leak/Splash” (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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Device problems

  • Leak/Splash2
  • Suction Problem2
  • Deformation Due to Compressive Stress1
  • Material Deformation1

Patient problems

  • No Consequences Or Impact To Patient2

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

  • MalfunctionNov 20, 2019Leak/Splash; Suction Problem; Material Deformation; Leak/Splash; Suction Problem; Material Deformation

    AN ATTEMPT WAS MADE TO USE A STAND ALONE EXPORT ASPIRATION CATHETER TO TREAT A NON TORTUOUS, NON CALCIFIED SOFT TISSUE LESION EXHIBITING 70% STENOSIS IN THE PROXIMAL RIGHT TIBIAL/POPLITEAL TRUNK. THE VESSEL WAS OCCLUDED DUE TO THROMBUS. THE DEVICE WAS INSPECTED WITH NO ISSUES. THE DEVICE WAS PREPPED WITH NO ISSUES NOTED. IT WAS REPORTED THAT THE DEVICE WAS ADVANCED TOWARDS THE PROXIMAL AT BUT IT DID NOT ASPIRATE, IT WAS REPLACED WITH ANOTHER DEVICE AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THE PATIENT IS ALIVE WITH NO INJURY.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 9346209 ↗
  • MalfunctionSep 23, 2019Leak/Splash; Suction Problem; Deformation Due to Compressive Stress; Leak/Splash; Suction Problem; Deformation Due to Compressive Stress

    AN EXPORT STAND ALONE CATHETER WAS USED DURING A PROCEDURE TO TREAT A NON-CALCIFIED, NON-TORTUOUS LESION EXHIBITING 100% STENOSIS IN THE MID SFA/POPLITEAL. THERE WAS NO DAMAGE NOTED TO THE PACKAGING. THE DEVICE WAS REMOVED FROM PACKAGING PER IFU WITH NO ISSUES. THE DEVICE WAS PREPPED PER IFU WITH NO ISSUES. THERE WAS NO RESISTANCE ENCOUNTERED WHEN ADVANCING THE DEVICE AND EXCESSIVE FORCE WAS NOT USED. IT WAS REPORTED THAT THE DEVICE FAILED TO ASPIRATE. THERE WERE 5 SUCCESSFUL ASPIRATIONS PRIOR TO THE ISSUE. THE PATIENT IS ALIVE WITH NO INJURY.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 9102621 ↗

Other CATHETER, EMBOLECTOMY devices

All CATHETER, EMBOLECTOMY devices →

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