Z2 Z26FR40Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00613994813602), received between Jul 9, 2018 and Jul 9, 2018 — classified as 1 malfunction.

The most frequently reported specific device problem is “Break” (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.

• MalfunctionJul 9, 2018Break; Detachment of Device or Device Component; Physical Resistance/Sticking

  A ZUMA GUIDE CATHETER WAS USED DURING A PROCEDURE, FEMORAL APPROACH WAS USED. THE INTENDED LESION WAS IN THE LAD AND WAS VERY TORTUOUS. NO DAMAGE WAS NOTED TO THE DEVICE PACKAGING. THE DEVICE WAS REMOVED FROM PACKAGING PER IFU. THE DEVICE WAS INSPECTED AND PREPPED PRIOR TO USE. A LARGE 45 CM SHEATH WAS ALSO USED. RESISTANCE WAS ENCOUNTERED ADVANCING THE ZUMA, IT COULD NOT REACH THE TARGET LESION. APPROXIMATELY A HALF TO ONE THIRD OF THE ZUMA BROKE OFF IN THE SHEATH PRIOR TO THE ATTEMPTED BALLOON DELIVERY. THE PHYSICIAN WAS ABLE TO REMOVE THE GUIDE WITH THE SHEATH WITH NO HARM TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7669712 ↗

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-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-1026-06 · Apr 5, 2006 · Terminated
  6F Z2 GUIDING CATHETER SR4.0 CATHETER Z26SR40 Z2 6F 100CM SR40 Coronary Guiding catheter designed to provide a pathway through which therapeutic and/or diagnostic devices are intr
• 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-1016-06 · Apr 5, 2006 · Terminated
  6F Z2 FL 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-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-1028-06 · Apr 5, 2006 · Terminated
  6F Z2 GUIDING CATHETER SR5.0 CATHETER Z26SR50 Z2 6F 100CM SR50 Coronary Guiding catheter designed to provide a pathway through which therapeutic and/or diagnostic devices are intr
• Z-1022-06 · Apr 5, 2006 · Terminated
  6F Z2 GUIDING CATHETER SR3.0 CATHETER Z26SR30 Z2 6F 100CM SR30 Coronary Guiding catheter designed to provide a pathway through which therapeutic and/or diagnostic devices are intr
• 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-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
• 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-1038-06 · Apr 5, 2006 · Terminated
  7F ZUMA 2 SR4.0 100CM CATHETER Z27SR40 Z2 7F 100CM SR40 Coronary Guiding catheter designed to provide a pathway through which therapeutic and/or diagnostic devices are introduced i
• 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-1021-06 · Apr 5, 2006 · Terminated
  6F Z2 MP1 110CM CATHETER Z26MP1A Z2 6F 110CM MP1 Coronary Guiding catheter designed to provide a pathway through which therapeutic and/or diagnostic devices are introduced into th
• Z-1018-06 · Apr 5, 2006 · Terminated
  6F Z2 JR 4.0 110CM CATHETER Z26JR40A Z2 6F 110CM JR40 Coronary Guiding catheter designed to provide a pathway through which therapeutic and/or diagnostic devices are introduced in

…and 12 more.