Z2 ZM5JL30Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00613994817068), received between Feb 14, 2017 and Feb 14, 2017 — classified as 1 injury.

The most frequently reported specific device problem is “Difficult to Remove” (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.

• InjuryFeb 14, 2017Difficult to Remove; Material Deformation; Difficult to Remove; Material Deformation

  THE PHYSICIAN WAS ATTEMPTING TO USE A ZUMA GUIDE CATHETER DURING AN ANGIOPLASTY PROCEDURE. NO DAMAGE WAS NOTED TO PACKAGING. THE DEVICE WAS REMOVED FROM PACKAGING PER IFU WITH NO ISSUES NOTED. THE DEVICE WAS INSPECTED AND PREPPED WITH NO ISSUES NOTED. NO RESISTANCE WAS ENCOUNTERED WHEN ADVANCING THE DEVICE, HOWEVER IT WAS REPORTED THAT EXCESSIVE FORCE WAS USED ON DELIVERY. IT WAS REPORTED THAT THE TIP OF THE ZUMA WAS DAMAGED. THE CATHETER WAS FOLDED IN THE DIGITAL ARTERIES AT TWO LOCATIONS. THERE WAS NO EXCESSIVE TORQUING. TO REMOVE THE GUIDE, CUTTING OF THE GUIDE BY SCALPEL WAS REQUIRED. THIS WAS DONE WITHOUT VASCULAR DAMAGE. THERE WAS NO DETACHMENT. THE CATHETER REMAINED FOLDED. ALL OF THE ZUMA WAS SUCCESSFULLY REMOVED FROM THE PATIENT. THE PATIENT EXPERIENCED PAIN ASSOCIATED WITH FORCED REMOVAL. THE PATIENT REQUIRED ANALGESICS. NO HEMATOMA REPORTED

  Patient problems: Pain; Patient Problem/Medical Problem

  MAUDE report 6328339 ↗

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-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
• 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