Z2 ZM5AL10Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00613994817228), received between May 28, 2021 and May 28, 2021 — classified as 1 malfunction.

The most frequently reported specific device problem is “Material Deformation” (1 report).

5 other recalls cover devices cleared under the same FDA submission (K990707); 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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

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

• MalfunctionMay 28, 2021Material Deformation; Material Deformation

  DURING A PROCEDURE AN ATTEMPT WAS MADE TO USE ONE ZUMA GUIDE CATHETER TO TREAT A LESION IN THE LAD. THERE WAS NO DAMAGE NOTED TO THE PACKAGING. THE DEVICE WAS REMOVED FROM THE PACKAGING WITH NO ISSUE. THE DEVICE WAS INSPECTED AND PREPPED PER IFU WITH NO ISSUES NOTED. IT WAS REPORTED THAT THE CATHETER WAS KINKED IN THE MID SHAFT, THE KINK OCCURRED WHEN TRYING TO POSITION THE CATHETER WHILE IN PATIENT. IT WAS NOTED THAT THE GUIDE CATHETER WAS INSERTED AS NORMAL OVER A .035 WIRE, WHEN AN ATTEMPT WAS MADE TO POSITION THE GUIDE AFTER THE .035 WIRE WAS REMOVED THE GUIDE WOULD NOT RESPOND. AN X-RAY OF THE LENGTH OF THE GUIDE SHOWED THE SHAFT HAD TWISTED/COLLAPSED. THE GUIDE WAS REMOVED AND THE CASE WAS SUCCESSFULLY COMPLETED USING ANOTHER GUIDE CATHETER. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11899883 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K990707. One submission often covers many models, so check the product and lot details in each record.

• Z-2754-2011 · Jun 8, 2011 · Terminated
  Medtronic 6F Zuma Guide Catheter with AL 1.5 Curve with side holes Catalog Number: Z26AL15SH The Medtronic Guiding Catheter is designed to provide a pathway through which therap
• Z-1056-06 · Apr 5, 2006 · Terminated
  5F ZUMA SR4.0 CATHETER ZM5SR40 Z2 5F 100CM SR40 Coronary Guiding catheter designed to provide a pathway through which therapeutic and/or diagnostic devices are introduced into the
• Z-1054-06 · Apr 5, 2006 · Terminated
  5F ZUMA SR3.0 CATHETER ZM5SR30 Z2 5F 100CM SR30 Coronary Guiding catheter designed to provide a pathway through which therapeutic and/or diagnostic devices are introduced into the
• Z-1055-06 · Apr 5, 2006 · Terminated
  ZM5SR35 5F ZUMA SR3.5 CATHETER ZM5SR35 Z2 5F 100CM SR35 Coronary Guiding catheter designed to provide a pathway through which therapeutic and/or diagnostic devices are introduced
• Z-1057-06 · Apr 5, 2006 · Terminated
  5F ZUMA SR5.0 Coronary Guiding catheter designed to provide a pathway through which therapeutic and/or diagnostic devices are introduced into the coronary or peripheral vascular s