Z2 Z26EBU375Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00613994813022), received between Apr 20, 2023 and Apr 20, 2023 — classified as 1 injury.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (1 report).

27 other recalls cover devices cleared under the same FDA submission (K010579); 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.

• InjuryApr 20, 2023Difficult to Remove; Detachment of Device or Device Component; Difficult to Remove; Detachment of Device or Device Component

  AN ATTEMPT WAS MADE TO USE ONE 6F ZUMA GUIDE CATHETER IN THE PROXIMAL LEFT MAIN (LM) CORONARY ARTERY. THE DEVICE WAS INSPECTED WITH NO ISSUES. THE DEVICE WAS PREPPED PER IFU WITH NO ISSUES. IT WAS REPORTED THAT THE TIP APPEARED DEFECTIVE, AND GOT STUCK IN THE FEMORAL ARTERY IN THE LEG. IT WAS DETAILED THAT THE CATHETER WAS LIGHTLY TWISTED TO ENGAGE IN THE LEFT CORONARY, WITHOUT FEELING MUCH RESISTANCE AT FIRST. IT LOOKED LIKE THE TIP WAS DEFECTIVE AND AN ATTEMPT WAS MADE TO PULL OUT THE DEVICE. HOWEVER, WHEN IT WAS ATTEMPTED TO REMOVE THE DEVICE THE TIP GOT STUCK IN THE FEMORAL ARTERY. A FEMORAL CUT-DOWN SURGICAL PROCEDURE HAD TO BE PERFORMED TO REMOVE THE DETACHED TIP. THE PATIENT HAD CATHETERIZATION PROCEDURE TWO DAYS LATER WITH A RADIAL APPROACH AND IS REPORTED TO BE DOING WELL. THE PATIENT IS ALIVE WITH NO FURTHER INJURY.

  Patient problems: Insufficient Information

  MAUDE report 16774628 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K010579. 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-1030-06 · Apr 5, 2006 · Terminated
  7F Z2 FR 4.0 110CM Coronary Guiding catheter designed to provide a pathway through which therapeutic and/or diagnostic devices are introduced into the coronary or peripheral vascu
• Z-1020-06 · Apr 5, 2006 · Terminated
  CATH GUIDE 6F MB2 110CM Z2 CATHETER Z26MB2A Z2 6F 110CM MB2 Coronary Guiding catheter designed to provide a pathway through which therapeutic and/or diagnostic devices are introdu
• Z-1024-06 · Apr 5, 2006 · Terminated
  6F Z2 GUIDING CATHETER SR3.5 CATHETER Z26SR35 Z2 6F 100CM SR35 Coronary Guiding catheter designed to provide a pathway through which therapeutic and/or diagnostic devices are intr
• Z-1036-06 · Apr 5, 2006 · Terminated
  7F ZUMA 2 SR3.5 100CM CATHETER Z27SR35 Z2 7F 100CM SR35 Coronary Guiding catheter designed to provide a pathway through which therapeutic and/or diagnostic devices are introduced
• Z-1040-06 · Apr 5, 2006 · Terminated
  7F ZUMA 2 SR5.0 100CM CATHETER Z27SR50 Z2 7F 100CM SR50 Coronary Guiding catheter designed to provide a pathway through which therapeutic and/or diagnostic devices are introduced
• Z-1027-06 · Apr 5, 2006 · Terminated
  6F Z2 GUIDING CATH SR4.0 SH CATHETER Z26SR40SH Z2 6F 100CM SR40 Coronary Guiding catheter designed to provide a pathway through which therapeutic and/or diagnostic devices are intr
• Z-1017-06 · Apr 5, 2006 · Terminated
  6F Z2 JL 4.0 110CM CATHETER Z26JL40A Z2 6F 110CM JL40 Coronary Guiding catheter designed to provide a pathway through which therapeutic and/or diagnostic devices are introduced in
• Z-1039-06 · Apr 5, 2006 · Terminated
  7F ZUMA 2 SR4.0 SH 100CM CATHETER Z27SR40SH Z2 7F 100CM SR40 Coronary Guiding catheter designed to provide a pathway through which therapeutic and/or diagnostic devices are introdu
• Z-1032-06 · Apr 5, 2006 · Terminated
  7F ZUMA 2 JR 4.0 110CM Coronary Guiding catheter designed to provide a pathway through which therapeutic and/or diagnostic devices are introduced into the coronary or peripheral v
• Z-1029-06 · Apr 5, 2006 · Terminated
  6F Z2 GUIDING CATH SR5.0 SH CATHETER Z26SR50SH Z2 6F 100CM SR50 Coronary Guiding catheter designed to provide a pathway through which therapeutic and/or diagnostic devices are int
• Z-1025-06 · Apr 5, 2006 · Terminated
  6F Z2 GUIDING CATH SR3.5 SH CATHETER Z26SR35SH Z2 6F 100CM SR35 Coronary Guiding catheter designed to provide a pathway through which therapeutic and/or diagnostic devices are int
• Z-1014-06 · Apr 5, 2006 · Terminated
  CATHETER Z26EBU35A Z2 6F 110CM EB35 Z26 EBU35 Coronary Guiding catheter designed to provide a pathway through which therapeutic and/or diagnostic devices are introduced into the c
• Z-1037-06 · Apr 5, 2006 · Terminated
  7F ZUMA 2 SR3.5 SH 100CM Coronary Guiding catheter designed to provide a pathway through which therapeutic and/or diagnostic devices are introduced into the coronary or peripheral
• Z-1023-06 · Apr 5, 2006 · Terminated
  6F Z2 GUIDING CATH SR3.0 SH CATHETER Z26SR30SH Z2 6F 100CM SR30 Coronary Guiding catheter designed to provide a pathway through which therapeutic and/or diagnostic devices are int

…and 12 more.