Launcher LA6IMAKRecalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 00613994821126), received between Nov 26, 2019 and Apr 24, 2024 — classified as 8 injuries, 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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• InjuryApr 24, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING THE INDEX PROCEDURE ONE SYMPLICITY SPYRAL CATHETER AND ONE LAUNCHER GUIDE CATHETER WERE USED TO TREAT THE RENAL ARTERIES. ON THE DAY OF THE PROCEDURE PATIENT SUFFERED RENAL ARTERY SPASM. IT WAS REPORTED THAT THE PATIENT BECAME AGITATED DUE TO PAIN DURING TREATMENT AND STARTED MOVING BOTH LEGS. THIS RESULTED IN THE CATHETER FAULTING INTERRUPTING THE ABLATION. THE CATHETER WAS WITHDRAWN INTO THE GUIDE. FOLLOW-UP ANGIOGRAPHY SHOWED A COUPLE OF AREAS OF SPASM IN THE MIDPORTION OF THE ARTERY AS WELL AS NEAR THE OSTIUM. THE PATIENT WAS GIVEN SERIAL DOSES OF INTRA-ARTERIAL NITROGLYCERIN WITH INCOMPLETE RESOLUTION. A 4 MM X 12 MM MEDTRONIC EUPHORA CORONARY BALLOON WAS INFLATED IN THE MIDPORTION OF THE VESSEL HAD A RESIDUAL AREA OF SPASM TO 4 ATM FOR 30 SECONDS. IT WAS THEN WITHDRAWN TO THE OSTIUM OF THE VESSEL WHERE A 5 ATM 30 SECOND INFLATION WAS PERFORMED. FOLLOW-UP ANGIOGRAPHY AFTER AN ADDITIONAL 200 MCG INTRACORONARY NITROGLYCERIN SHOWED WIDELY PATENT AREAS WITHOUT RESIDUAL SPASM. THE PATIENT HAS RECOVERED. THE INVESTIGATOR AND THE SPONSOR ASSESSED THE EVENT AS CASUALLY RELATED TO THE PROCEDURE AND THE THERAPY AND POSSIBLY RELATED TO THE STUDY CATHETER. THERE IS NO REPORTED MALF

  Patient problems: Obstruction/Occlusion; Pain

  MAUDE report 19174937 ↗
• InjuryFeb 8, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING THE INDEX PROCEDURE ONE SYMPLICITY SPYRAL CATHETER, ONE LAUNCHER GUIDE CATHETER, ONE THUNDER GUIDEWIRE AND A SYMPLICITY G3 GENERATOR WERE USED TO TREAT THE RENAL ARTERIES . ON THE SAME DAY POST PROCEDURE THE PATIENT SUFFERED FROM A RIGHT GROIN OOZE. MANUAL PRESSURE WAS HELD AT THE OOZE SITE WITHOUT RESOLUTION. AN INJECTION OF LIDOCAINE-EPINEPHRINE INTO THE OOZE SITE RESOLVED THE ISSUE. THE PATIENT HAS RECOVERED. THE RATIONALE FOR THE RELATIONSHIP TO THE STUDY PROCEDURE WAS THAT THE RIGHT GROIN OOZE OCCURRED POST PROCEDURE. THERE ARE NO REPORTED MALFUNCTIONS FOR THE LAUNCHER GUIDE CATHETER, THUNDER GUIDEWIRE AND SYMPLICITY G3 GENERATOR USED DURING THE PROCEDURE.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 18668033 ↗
• InjuryFeb 8, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING THE INDEX PROCEDURE ONE SYMPLICITY SPYRAL CATHETER, ONE LAUNCHER GUIDE CATHETER, ONE THUNDER GUIDEWIRE AND A SYMPLICITY G3 GENERATOR WERE USED TO TREAT THE RENAL ARTERIES. DURING THE PROCEDURE THE PATIENT SUFFERED FROM BRADYCARDIA. THE EVENT WAS TREATED WITH MEDICATION (ATROPINE). THE PATIENT HAS RECOVERED. THE RATIONALE FOR THE RELATIONSHIP TO THE PROCEDURE, THERAPY, SYMPLICITY SPYRAL, LAUNCHER CATHETER AND SYMPLICITY G3 GENERATOR WAS THAT THE PATIENT BECAME BRADYCARDIC DURING THE PROCEDURE WHEN DENERVATION STARTED. THERE IS NO REPORTED MALFUNCTION FOR THE LAUNCHER GUIDE CATHETER, THUNDER GUIDEWIRE OR THE SYMPLICITY GENERATOR G3 USED DURING THE PROCEDURE.

  Patient problems: Bradycardia

  MAUDE report 18665911 ↗
• InjuryAug 10, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING THE INDEX PROCEDURE ONE SIMPLICITY SPIRAL CATHETER, ONE LAUNCHER GUIDE CATHETER AND ONE THUNDER GUIDE WIRE WERE USED TO TREAT THE RENAL ARTERIES. DURING THE PROCEDURE THE PATIENT SUFFERED FROM A VASOVAGAL RESPONSE AND THE PATIENTS HEART STOPPED (ASYSTOLE) FOR 10 SECONDS. ATROPINE WAS ADMINISTERED. THE PATIENT IS RECOVERING. THERE IS NO REPORTED MALFUNCTION FOR THE LAUNCHER GUIDE CATHETER OR THUNDER GUIDE WIRE USED DURING THE PROCEDURE.

  Patient problems: Asystole; Syncope/Fainting

  MAUDE report 17496991 ↗
• MalfunctionFeb 9, 2022Use of Device Problem; Use of Device Problem

  AN ATTEMPT WAS MADE TO USE A LAUNCHER GUIDE CATHETER TO TREAT THE LEFT RENAL ARTERY. THE PATIENT SUFFERED FROM MODERATE SPAMS. THE DEVICE WAS NOTED AS USED AFTER THE EXPIRING DATE. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13497758 ↗
• InjuryJan 18, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING THE INDEX PROCEDURE ONLY SYMPLICITY SPYRAL GUIDE CATHETER, ONE LAUNCHER GUIDE CATHETER AND ONE THUNDER GUIDEWIRE WERE USED TO TREAT THE LEFT AND RIGHT RENAL ARTERIES. ON THE SAME DAY POST PROCEDURE THE PATIENT SUFFERED RETROSPECTIVE WIRE DISSECTION LOWER BRANCH ARTERY. THE PATIENT WAS DISCHARGED ONE DAY POST PROCEDURE. THERE IS NO REPORTED MALFUNCTION FOR THE LAUNCHER GUIDE CATHETER AND THUNDER GUIDEWIRE USED DURING THE PROCEDURE.

  Patient problems: Vascular Dissection

  MAUDE report 13285670 ↗
• InjuryDec 1, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING THE INDEX PROCEDURE ONE SYMPLICITY SPYRAL CATHETER, ONE LAUNCHER GUIDE CATHETER AND TWO THUNDER GUIDE WIRES WERE USED. ON THE SAME DAY POST PROCEDURE PATIENT SUFFERED FROM PERFORATION IN THE RENAL ARTERY. THERE IS NO REPORTED MALFUNCTION FOR THE LAUNCHER GUIDE CATHETER AND THUNDER GUIDE WIRES USED DURING THE PROCEDURE.

  Patient problems: Perforation

  MAUDE report 12907143 ↗
• InjuryFeb 3, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT IS IN CONTROL GROUP. DURING INDEX PROCEDURE, A SHERPA GUIDE CATHETER WAS USED. THERE WAS NO MALFUNCTION REPORTED AGAINST THE DEVICE. DURING THE PROCEDURE, A CIRCUMSCRIPT RETROGRADE DISSECTION (RIGHT ILIAC ARTERY) AFTER CONTRAST INJECTION VIA GUIDING CATHETER OCCURRED. EVENT IS CONTINUING WITHOUT TREATMENT. INVESTIGATOR ASSESSED EVENT IS NOT RELATED TO THE DEVICE OR RENAL DENERVATION THERAPY BUT RELATED TO PROCEDURE.

  Patient problems: Intimal Dissection; Vascular Dissection

  MAUDE report 9658726 ↗
• InjuryNov 26, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE CORE LAB NOTED A DISSECTION IN ONE OF THE BRANCHES OF THE RIGHT RENAL ARTERY DURING THE PROCEDURE. THE PATIENT RECOVERED WITHOUT SEQUELAE. THE SITE ASSESSED THE EVENT AS DEFINITELY PROCEDURE RELATED AND POSSIBLY RELATED TO THE STUDY CATHETER. THE SPONSOR ASSESSED THE EVENT AS PROCEDURE RELATED AND POSSIBLY RELATED TO THE SPYRAL CATHETER.

  Patient problems: Intimal Dissection

  MAUDE report 9376454 ↗

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-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-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-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-1000-06 · Apr 5, 2006 · Terminated
  CATHETER SA6SR50 SA 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-0937-06 · Apr 5, 2006 · Terminated
  CATH. GUIDE 6F 3DRC LAUNCHER CATHETER LA63DRC LA 6F 100CM 3DRC Coronary Guiding catheter designed to provide a pathway through which therapeutic and/or diagnostic devices are intro
• 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-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
• Z-0952-06 · Apr 5, 2006 · Terminated
  CATH. GUIDE 6F JR4.0 110CM LAU CATHETER LA6JR40A LA 6F 110CM JR40 Coronary Guiding catheter designed to provide a pathway through which therapeutic and/or diagnostic devices are i
• Z-0996-06 · Apr 5, 2006 · Terminated
  CATHETER SA63DRC SA 6F 100CM 3 CATHETER SA63DRC SA 6F 100CM 3DRC Coronary Guiding catheter designed to provide a pathway through which therapeutic and/or diagnostic devices are in
• 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-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-1001-06 · Apr 5, 2006 · Terminated
  CATHETER SB63DRC SB 6F 100CM 3 CATHETER SB63DRC SB 6F 100CM 3DRC Coronary Guiding catheter designed to provide a pathway through which therapeutic and/or diagnostic devices are in

…and 37 more.