Launcher LA6JR40 (UDI 00763000508395)Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00763000508395), received between May 6, 2022 and Jul 20, 2023 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Activation Failure” (1 report).

52 other recalls cover devices cleared under the same FDA submission (K021256); 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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 20, 2023Use of Device Problem; Use of Device Problem

  A 6F LAUNCHER GUIDE CATHETER WAS USED DURING A PROCEDURE IN THE LEFT ANTERIOR DESCENDING (LAD) ARTERY. THE DEVICE WAS INSPECTED BEFORE USE WITH NO ISSUES NOTED. THE DEVICE WAS PREPPED PER IFU WITH NO ISSUES. RESISTANCE WAS NOT ENCOUNTERED WHEN ADVANCING THE DEVICE. EXCESSIVE FORCE WAS NOT USED. IT WAS REPORTED THAT THE DEVICE WAS EXPIRED AT THE TIME OF USE. IT WAS DETAILED THAT PRIOR TO OPENING THE PRODUCT THE DEVICE WAS DOUBLE CHECKED AND BELIEVED TO NOT BE EXPIRED. HOWEVER, AFTER USE IT WAS FOUND THAT THE BATCH NUMBER FOR THE PRODUCT WAS EXPIRED. THE DEVICE WAS USED DURING THE PROCEDURE. THE PATIENT IS ALIVE WITH NO INJURY AND IS DESCRIBED AS DOING WELL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17360591 ↗
• MalfunctionMay 6, 2022Material Deformation; Activation Failure

  EBU CATHETER WAS DEFECTIVE. FLATTENED IN THE MIDDLE AND DID NOT ALLOW FOR PASSAGE OF GUIDE EXTENSION. WE NEED GUIDE EXTENSION FOR SUPPORT BUT THE FLATTENED REGION OF THE 6 FR EBU 3.5 CATHETER HINDERED DELIVERY OF BOTH GUIDELINER AND TELESCOPE. WE HAD TO TAKE THE CATHETER OUT, CORONARY WIRE OUT. RE ENGAGE WITH ANOTHER GUIDE CATHETER AND REWIRE THE VESSEL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14309587 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K021256. One submission often covers many models, so check the product and lot details in each record.

• Z-1245-2021 · Jan 15, 2021 · Terminated
  Medtronic 6F Launcher Guide Catheter 100 cmJL 3.5 Model Number: LA6JL35
• Z-1247-2021 · Jan 15, 2021 · Terminated
  Medtronic 6F Launcher Guide Catheter 100cm EBU 3.75 Model Number: LA6EBU375
• Z-1246-2021 · Jan 15, 2021 · Terminated
  Medtronic 6F Launcher Guide Catheter 100 cm JR 4.0 Model Number: LA6JR40
• Z-1248-2021 · Jan 15, 2021 · Terminated
  Medtronic 6F Launcher Guide Catheter 100 cm EBU 3.0 Model Number: LA6EBU30
• Z-0205-2015 · Oct 13, 2014 · Terminated
  Medtronic Launcher Coronary Guide Catheter; MODEL: LA6JR40K
• Z-1564-2013 · Jun 12, 2013 · Terminated
  Medtronic, Launcher Guiding Catheter, Model # LA8EBU45SH, Lot # 0006722866, 8F and Model # LA6IMAD, Lot # 0006724224, 6F Product Usage: The Medtronic Guiding Catheter is designe
• Z-0944-06 · Apr 5, 2006 · Terminated
  CATH GUIDE 6F LAUNCHER EBU 4.5 CATHETER LA6EBU45A LA 6F 110CM EB45 Coronary Guiding catheter designed to provide a pathway through which therapeutic and/or diagnostic devices are
• Z-0951-06 · Apr 5, 2006 · Terminated
  CATH. GUIDE 6F JL5.0 110CM LAU CATHETER LA6JL50A LA 6F 110CM JL50 Coronary Guiding catheter designed to provide a pathway through which therapeutic and/or diagnostic devices are i
• Z-0948-06 · Apr 5, 2006 · Terminated
  CATH. GUIDE 6F JL4.0 110CM LAU CATHETER LA6JL40A LA 6F 110CM JL40 Coronary Guiding catheter designed to provide a pathway through which therapeutic and/or diagnostic devices are i
• Z-0996-06 · Apr 5, 2006 · Terminated
  CATHETER SA63DRC SA 6F 100CM 3 CATHETER SA63DRC SA 6F 100CM 3DRC Coronary Guiding catheter designed to provide a pathway through which therapeutic and/or diagnostic devices are in
• Z-1004-06 · Apr 5, 2006 · Terminated
  CATHETER SB6SR35 SB 6F 100CM S Coronary Guiding catheter designed to provide a pathway through which therapeutic and/or diagnostic devices are introduced into the coronary or peri
• Z-0968-06 · Apr 5, 2006 · Terminated
  CATH. GUIDE 6F SR6.0 W/SH LAUN Coronary Guiding catheter designed to provide a pathway through which therapeutic and/or diagnostic devices are introduced into the coronary or peri
• Z-0997-06 · Apr 5, 2006 · Terminated
  CATHETER SA63DRCSH Coronary Guiding catheter designed to provide a pathway through which therapeutic and/or diagnostic devices are introduced into the coronary or peripheral vascu
• Z-0952-06 · Apr 5, 2006 · Terminated
  CATH. GUIDE 6F JR4.0 110CM LAU CATHETER LA6JR40A LA 6F 110CM JR40 Coronary Guiding catheter designed to provide a pathway through which therapeutic and/or diagnostic devices are i
• Z-1000-06 · Apr 5, 2006 · Terminated
  CATHETER SA6SR50 SA 6F 100CM Coronary Guiding catheter designed to provide a pathway through which therapeutic and/or diagnostic devices are introduced into the coronary or peri

…and 37 more.