Launcher LA6JL40 (UDI 00613994818218)Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00613994818218), received between Oct 16, 2018 and Oct 16, 2018 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Use of Device Problem” (3 reports).

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 18, 2026.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 16, 2018Use of Device Problem; Use of Device Problem

  IT IS REPORTED THAT AN EXPIRED LAUNCHER DEVICE WAS USED DURING A PROCEDURE. NO PATIENT INJURY REPORTED. THE PRODUCTS WERE NOT EXPIRED WHEN THE DISTRIBUTOR SENT THE ITEM TO THE HOSPITAL. IT WAS CONFIRMED THAT THE DEVICE WAS EXPIRED BY THE USAGE REPORT PROVIDED BY THE MEDTRONIC REP AND CONFIRMED WITH THE CATH LAB. THE PROCESS FOR CONTROLLING SHORT DATED/EXPIRED PRODUCT AT THE ACCOUNT IS AGING MONITORING OF EXPIRATION DATES AND PULL-OUT OF THE NEAR EXPIRY ITEMS BEFORE 30 DAYS FROM THE EXPIRATION DATE. PRODUCTS ARE MANAGED BY THE HOSPITAL THROUGH CONSIGNMENT AND CURRENT PROCESS IS INVENTORY BEING MONITORED BY THE DISTRIBUTOR AND MEDTRONIC.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7968599 ↗
• MalfunctionOct 16, 2018Use of Device Problem; Use of Device Problem

  IT IS REPORTED THAT AN EXPIRED LAUNCHER DEVICE WAS USED DURING A PROCEDURE. NO PATIENT INJURY REPORTED. THE PRODUCTS WERE NOT EXPIRED WHEN THE DISTRIBUTOR SENT THE ITEM TO THE HOSPITAL. IT WAS CONFIRMED THAT THE DEVICE WAS EXPIRED BY THE USAGE REPORT PROVIDED BY THE MEDTRONIC REP AND CONFIRMED WITH THE CATH LAB. THE PROCESS FOR CONTROLLING SHORT DATED/EXPIRED PRODUCT AT THE ACCOUNT IS AGING MONITORING OF EXPIRATION DATES AND PULL-OUT OF THE NEAR EXPIRY ITEMS BEFORE 30 DAYS FROM THE EXPIRATION DATE. PRODUCTS ARE MANAGED BY THE HOSPITAL THROUGH CONSIGNMENT AND CURRENT PROCESS IS INVENTORY BEING MONITORED BY THE DISTRIBUTOR AND MEDTRONIC.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7968595 ↗
• MalfunctionOct 16, 2018Use of Device Problem; Use of Device Problem

  IT IS REPORTED THAT AN EXPIRED LAUNCHER DEVICE WAS USED DURING A PROCEDURE. NO PATIENT INJURY REPORTED. THE PRODUCTS WERE NOT EXPIRED WHEN THE DISTRIBUTOR SENT THE ITEM TO THE HOSPITAL. IT WAS CONFIRMED THAT THE DEVICE WAS EXPIRED BY THE USAGE REPORT PROVIDED BY THE MEDTRONIC REP AND CONFIRMED WITH THE CATH LAB. THE PROCESS FOR CONTROLLING SHORT DATED/EXPIRED PRODUCT AT THE ACCOUNT IS AGING MONITORING OF EXPIRATION DATES AND PULL-OUT OF THE NEAR EXPIRY ITEMS BEFORE 30 DAYS FROM THE EXPIRATION DATE. PRODUCTS ARE MANAGED BY THE HOSPITAL THROUGH CONSIGNMENT AND CURRENT PROCESS IS INVENTORY BEING MONITORED BY THE DISTRIBUTOR AND MEDTRONIC.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7968581 ↗

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-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-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-0959-06 · Apr 5, 2006 · Terminated
  CATH. GUIDE 6F SR3.5 W/SH LAUN CATHETER LA6SR35SH LA 6F 100CM SR35 Coronary Guiding catheter designed to provide a pathway through which therapeutic and/or diagnostic devices are
• Z-0957-06 · Apr 5, 2006 · Terminated
  CATH. GUIDE 6F SR3.0 W/SH LAUN CATHETER LA6SR30SH LA 6F 100CM SR30 Coronary Guiding catheter designed to provide a pathway through which therapeutic and/or diagnostic devices are
• Z-0941-06 · Apr 5, 2006 · Terminated
  CATH GUIDE 6F LAUNCHER AL 3.0 CATHETER LA6AL30A LA 6F 110CM AL30 Coronary Guiding catheter designed to provide a pathway through which therapeutic and/or diagnostic devices are in
• 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-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-1002-06 · Apr 5, 2006 · Terminated
  CATHETER SB63DRCSH SB 6F 100CM Coronary Guiding catheter designed to provide a pathway through which therapeutic and/or diagnostic devices are introduced into the coronary or peri
• 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-1019-06 · Apr 5, 2006 · Terminated
  CATH, GUIDE 6F JR4.0 SH 110CM Coronary Guiding catheter designed to provide a pathway through which therapeutic and/or diagnostic devices are introduced into the coronary or perip
• Z-0939-06 · Apr 5, 2006 · Terminated
  CATH. GUIDE 6F AL 1.0 110CM LA CATHETER LA6AL10A LA 6F 110CM AL10 Coronary Guiding catheter designed to provide a pathway through which therapeutic and/or diagnostic devices are i

…and 37 more.