Launcher LA6RDCKRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00613994819406), received between Jan 6, 2022 and Jan 6, 2022 — classified as 1 injury.

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.

• InjuryJan 6, 2022Use of Device Problem; Adverse Event Without Identified Device or Use Problem; Use of Device Problem; Adverse Event Without Identified Device or Use Problem

  DURING A RENAL DENERVATION PROCEDURE (RDN), ONE SYMPLICITY SPYRAL CATHETER, ONE LAUNCHER GUIDE CATHETER, ONE SHERPA GUIDE CATHETER AND ONE THUNDER GUIDEWIRE WERE USED TO TREAT THE RENAL ARTERIES. THE DEVICES WERE USED IN THE PROCEDURE APPROXIMATELY FIVE MONTHS PAST THEIR EXPIRATION DATE. ON THE SAME DAY POST RDN PROCEDURE, PATIENT SUFFERED PERFORATION IDENTIFIED POST TREATMENT IN THE RIGHT RENAL ARTERY. THE PROCEDURE WAS COMPLETED AND PATIENT WAS DISCHARGED THE NEXT DAY.

  Patient problems: Perforation

  MAUDE report 13176226 ↗

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-1245-2021 · Jan 15, 2021 · Terminated
  Medtronic 6F Launcher Guide Catheter 100 cmJL 3.5 Model Number: LA6JL35
• 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-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-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-0938-06 · Apr 5, 2006 · Terminated
  CATH. GUIDE 6F 3DRC W/SH LAUNC CATHETER LA63DRCSH LA 6F 100CM 3DRC Coronary Guiding catheter designed to provide a pathway through which therapeutic and/or diagnostic devices are
• 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-0950-06 · Apr 5, 2006 · Terminated
  CATHETER LA6JL45A 6F 110CM JL4 CATHETER LA6JL45A 6F 110CM JL45 Coronary Guiding catheter designed to provide a pathway through which therapeutic and/or diagnostic devices are intr
• 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
• 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-1008-06 · Apr 5, 2006 · Terminated
  CATHETER SB6SR50 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-0953-06 · Apr 5, 2006 · Terminated
  CATH.GUIDE 6F JR 4.0 SH 110CM CATHETER LA6JR40SHA LA 6F 110CM JR40 Coronary Guiding catheter designed to provide a pathway through which therapeutic and/or diagnostic devices are

…and 37 more.