Launcher LA6FR40Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00613994820662), received between Jul 31, 2023 and Jul 31, 2023 — classified as 1 injury.

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

• InjuryJul 31, 2023Detachment of Device or Device Component; Material Deformation; Detachment of Device or Device Component; Material Deformation

  AN ATTEMPT WAS MADE TO USE ONE 6F LAUNCHER GUIDE CATHETER DURING A PROCEDURE. IT WAS REPORTED THAT A DEVICE DETACHMENT OCCURRED WHILE MANIPULATING THE CATHETER DURING THE PROCEDURE, INSIDE THE PATIENT. THE DETACHMENT OCCURRED AT THE MID-WAY POINT OF THE CATHETER, DISTAL TO THE GUIDE CATHETER HUB. INTERVENTION WAS REQUIRED TO REMOVE THE DETACHED PORTION. THE PATIENT IS ALIVE WITH NO FURTHER INJURY.

  Patient problems: Insufficient Information

  MAUDE report 17422564 ↗

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-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-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-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-0949-06 · Apr 5, 2006 · Terminated
  CATH.GUIDE 6F JL 4.0 SH 110CM CATHETER LA6JL40SHA LA 6F 110CM JL40 Coronary Guiding catheter designed to provide a pathway through which therapeutic and/or diagnostic devices are
• Z-0945-06 · Apr 5, 2006 · Terminated
  CATHETER LA6HSIA 6F 110CM HSI Coronary Guiding catheter designed to provide a pathway through which therapeutic and/or diagnostic devices are introduced into the coronary or perip
• 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-0942-06 · Apr 5, 2006 · Terminated
  CATH. GUIDE 6F EBU3.5 110CM LA CATHETER LA6EBU35A LA 6F 110CM EB35 Coronary Guiding catheter designed to provide a pathway through which therapeutic and/or diagnostic devices are
• Z-0963-06 · Apr 5, 2006 · Terminated
  CATH. GUIDE 6F SR4.5 LAUNCHER CATHETER LA6SR45 LA 6F 100CM SR45 Coronary Guiding catheter designed to provide a pathway through which therapeutic and/or diagnostic devices are int
• Z-0965-06 · Apr 5, 2006 · Terminated
  CATH. GUIDE 6F SR5.0 LAUNCHER CATHETER LA6SR50 LA 6F 100CM SR50 Coronary Guiding catheter designed to provide a pathway through which therapeutic and/or diagnostic devices are int
• 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-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

…and 37 more.