Z2 ZM5AR20Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00613994817310), received between Oct 28, 2020 and Oct 28, 2020 — classified as 1 malfunction.

The most frequently reported specific device problem is “Use of Device Problem” (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 16, 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.

• MalfunctionOct 28, 2020Use of Device Problem; Use of Device Problem

  DURING A PROCEDURE, ONE 5 FRENCH ZUMA CATHETER WAS USED TO TREAT A LESION. THE DEVICE WAS INSPECTED WITH NO ISSUES NOTED. THE DEVICE WAS PREPPED PER IFU WITH NO ISSUES NOTED. RESISTANCE WAS NOT ENCOUNTERED WHEN ADVANCING THE DEVICE. EXCESSIVE FORCE WAS NOT USED DURING INSERTION/DELIVERY. IT WAS REPORTED THAT THE CATHETER WAS EXPIRED WHEN USED WITH NO ISSUES REPORTED. THE PATIENT WAS REPORTED TO BE ALIVE WITH NO INJURIES.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10746001 ↗

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-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-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
• 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-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