Launcher LA6RBU35Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00613994819529), received between Jul 27, 2021 and Jul 27, 2021 — classified as 1 malfunction.

The most frequently reported specific device problem is “Use of Device Problem” (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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 27, 2021Use of Device Problem; Use of Device Problem

  ONE 6F LAUNCHER GUIDE CATHETER WAS USED. 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 AND EXCESSIVE FORCE WAS NOT USED. IT WAS REPORTED THAT PRODUCT WAS USED AFTER THE EXPIRY DATE. IT WAS STATED THAT THE PRODUCT WAS USED WITHOUT ISSUE AND THE PATIENT IS DOING FINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12230981 ↗

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-1248-2021 · Jan 15, 2021 · Terminated
  Medtronic 6F Launcher Guide Catheter 100 cm EBU 3.0 Model Number: LA6EBU30
• Z-1246-2021 · Jan 15, 2021 · Terminated
  Medtronic 6F Launcher Guide Catheter 100 cm JR 4.0 Model Number: LA6JR40
• Z-1247-2021 · Jan 15, 2021 · Terminated
  Medtronic 6F Launcher Guide Catheter 100cm EBU 3.75 Model Number: LA6EBU375
• Z-1245-2021 · Jan 15, 2021 · Terminated
  Medtronic 6F Launcher Guide Catheter 100 cmJL 3.5 Model Number: LA6JL35
• 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-0956-06 · Apr 5, 2006 · Terminated
  CATH. GUIDE 6F SR3.0 LAUNCHER CATHETER LA6SR30 LA 6F 100CM SR30 Coronary Guiding catheter designed to provide a pathway through which therapeutic and/or diagnostic devices are int
• Z-0947-06 · Apr 5, 2006 · Terminated
  CATH. GUIDE 6F JL4.0 5 PACK LA Coronary Guiding catheter designed to provide a pathway through which therapeutic and/or diagnostic devices are introduced into the coronary or peri
• Z-0962-06 · Apr 5, 2006 · Terminated
  CATH. GUIDE 6F SR4.0 W/SH LAUN CATHETER LA6SR40SH LA 6F 100CM SR40 Coronary Guiding catheter designed to provide a pathway through which therapeutic and/or diagnostic devices are
• 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-0998-06 · Apr 5, 2006 · Terminated
  CATHETER SA6SR35 SA 6F 100CM Coronary Guiding catheter designed to provide a pathway through which therapeutic and/or diagnostic devices are introduced into the coronary or perip
• 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-1003-06 · Apr 5, 2006 · Terminated
  CATHETER SB6SR30 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-0967-06 · Apr 5, 2006 · Terminated
  CATH. GUIDE 6F SR6.0 LAUNCHER CATHETER LA6SR60 LA 6F 100CM SR60 Coronary Guiding catheter designed to provide a pathway through which therapeutic and/or diagnostic devices are int
• Z-0966-06 · Apr 5, 2006 · Terminated
  CATH. GUIDE 6F SR5.0 W/SH LAUN CATHETER LA6SR50SH LA 6F 100CM SR50 Coronary Guiding catheter designed to provide a pathway through which therapeutic and/or diagnostic devices are

…and 37 more.