Launcher LA6ERADRRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00613994821508), received between May 27, 2019 and May 27, 2019 — classified as 1 injury.

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.

• InjuryMay 27, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING A PROCEDURE, AN ATTEMPT WAS MADE TO USE A 6F LAUNCHER GUIDE CATHETER TO DO A DIAGNOSTIC ON THE RCA. NO DAMAGE WAS NOTED TO PAC KAGING. THE DEVICE WAS REMOVED FROM THE PACKAGING AS PER IFU WITH NO ISSUES. THE DEVICE WAS INSPECTED WITH NO ISSUES NOTED. RESISTANCE WAS NOT ENCOUNTERED WHEN ADVANCING THE DEVICE AND EXCESSIVE FORCE WAS NOT USED DURING INSERTION. MULTIPLE CURVES WERE USED TO TRY TO CANNULATE THE RCA. THE LAUNCHER WAS USED AS NO OTHER CATHETERS WORKED. IT WAS REPORTED THAT WHEN THE CATHETER WAS INJECTED FOR A ROOT SHOT, AN AORTIC PERFORATION WAS NOTICED IN THE SUB INTIMAL TISSUE OF THE RIGHT CUSP. THE PATIENT WAS STABLE AND NO SURGERY WAS REQUIRED THAT DAY TO REPAIR THE PERFORATION. PATIENT WAS DISCHARGED THE FOLLOWING DAY.

  Patient problems: Perforation

  MAUDE report 8644151 ↗

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-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-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-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-1007-06 · Apr 5, 2006 · Terminated
  CATHETER SB6SR40SH 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-1005-06 · Apr 5, 2006 · Terminated
  CATHETER SB6SR35SH 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-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-0954-06 · Apr 5, 2006 · Terminated
  CATH. GUIDE 6F JR5.0 110CM LAU CATHETER LA6JR50A LA 6F 110CM JR50 Coronary Guiding catheter designed to provide a pathway through which therapeutic and/or diagnostic devices are i
• Z-0964-06 · Apr 5, 2006 · Terminated
  CATH. GUIDE 6F SR4.5 W/SH LAUN CATHETER LA6SR45SH LA 6F 100CM SR45 Coronary Guiding catheter designed to provide a pathway through which therapeutic and/or diagnostic devices are
• 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-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-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

…and 37 more.