Launcher LA6EBU35 (UDI 00613994819994)Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00613994819994), received between Jul 26, 2018 and Mar 21, 2024 — classified as 1 death, 1 injury, 3 malfunctions.

The most frequently reported specific device problem is “Material Deformation” (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 16, 2026.

Most reported problems

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• DeathMar 21, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING THE INDEX PROCEDURE TWO ONYX FRONTIER CORONARY DRUG ELUTING STENTS WERE IMPLANTED IN THE LEFT ANTERIOR DESCENDING ARTERY (LAD). ONE LAUNCHER GUIDE CATHETER, ONE EUPHORA BALLOON CATHETER, FIVE NC EUPHORA BALLOON CATHETERS, AND ONE TELESCOPE GUIDE EXTENSION CATHETER (GEC) WERE ALSO USED DURING THE PROCEDURE. NO COMPLICATIONS WERE REPORTED DURING THE PROCEDURE. ON THE SAME DAY POST PROCEDURE THE PATIENT SUFFERED FROM A SPONTANEOUS MYOCARDIAL INFARCTION (MI) AND CARDIAC ARREST / SUDDEN CARDIAC DEATH. THE PATIENT WAS DOING WELL AFTER THE PROCEDURE, HAD EATEN DINNER AND EVERYTHING WAS NORMAL WHEN SUDDENLY THE PATIENT COLLAPSED ON THE GROUND. THE PATIENT DID NOT HAVE ANY SYMPTOMS OF CHEST PAIN, DIAPHORESIS, NAUSEA, OR VOMITING. ADVANCED LIFE SAVING MEASURES WERE UTILIZED. EMERGENCY MEDICAL SERVICES (EMS) WAS CONTACTED AND A FAMILY MEMBER TRIED TO DO SOME MOUTH-TO-MOUTH UNTIL THE AMBULANCE ARRIVED. WHEN THE AMBULANCE ARRIVED, THEY DETECTED ELECTROMECHANICAL DISSOCIATION (EMD) AND STARTED CARDIOPULMONARY RESUSCITATION (CPR) FOR 30 MINUTES BEFORE THE PATIENT ARRIVED TO THE EMERGENCY ROOM (ER). ADDITIONAL CPR WAS PERFORMED, HOWEVER, THIS WAS UNSUCCESSFUL IN OBTAINING BLOOD PRESSURE. TH

  Patient problems: Cardiac Arrest; Myocardial Infarction

  MAUDE report 18947581 ↗
• MalfunctionApr 6, 2021Material Deformation; Material Deformation

  DURING A PROCEDURE, IT WAS INTENDED TO USE ONE 6 FRENCH LAUNCHER GUIDE CATHETER TO TREAT A NORMAL, NON CALCIFIED, NON TORTUOUS LESION. THERE WAS NO RESISTANCE NOTED WHILE REMOVING THE DEVICE FROM THE HOOP THERE WAS NO DAMAGE NOTED TO THE PACKAGING. IT WAS REPORTED THAT DAMAGE TO THE DEVICE WAS NOTED AND THE CURVE OF THE DEVICE WAS DIFFERENT THAN A NORMAL CURVE. IT WAS STATED THAT THE PHYSICIAN NOTED THE KINK PRIOR TO USE, BUT THE DEVICE WAS STILL USED. THE PHYSICIAN LATER REMOVED THE DEVICE AS IT WAS NOT COMFORTABLE. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11618231 ↗
• MalfunctionSep 17, 2019Material Deformation; Material Deformation

  A LAUNCHER GUIDE CATHETER WAS ATTEMPTED TO BE USED TO TREAT A NON CALCIFIED, MODERATELY TORTUOUS LEFT ANTERIOR DESCENDING (LAD) ARTERY. THERE WAS NO DAMAGE NOTED TO THE PACKAGING. THE DEVICE WAS REMOVED FROM PACKAGING AS PER IFU WITH NO ISSUES. THE DEVICE WAS INSPECTED WITH NO ISSUES NOTED. THE DEVICE WAS PREPPED PER IFU. RESISTANCE WAS ENCOUNTERED WHEN ADVANCING THE DEVICE. IT WAS INDICATED THAT THE DEVICE MAY HAVE BEEN EXCESSIVELY TORQUED. IT WAS REPORTED THAT THE DEVICE KINKED AT THE DISTAL END WHEN REMOVING THE DEVICE FROM THE PATIENT. THE PATIENT IS ALIVE WITH NO INJURY. AT THE FACILITY DEVICES ARE REMOVED FROM THE OUTER BOX AND HUNG UP. THE CATH LAB WILL NOT BE REVIEWED AS IT WAS STATED THAT LAUNCHERS HAVE A HANGING RACK AND ARE IN AN OPEN SPACE. THE DEVICE WAS RETURNED WITH A TORSIONAL KINK AND THE INNER MATERIAL SLIGHTLY EXPOSED AT THE KINK SITE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9075254 ↗
• MalfunctionJun 17, 2019Deformation Due to Compressive Stress; Material Deformation; Deformation Due to Compressive Stress; Material Deformation

  A LAUNCHER 6F GUIDE CATHETER WAS ATTEMPTED TO BE USED TO TREAT A NON TORTUOUS, NON CALCIFIED LESION IN THE LEFT MAIN (LM) CORONARY ARTERY. THERE WAS NO DAMAGE NOTED TO PACKAGING. THE DEVICE WAS REMOVED FROM THE PACKAGING AS PER IFU WITH NO ISSUES. THE DEVICE WAS INSPECTED AND PREPPED AS PER IFU WITH NO ISSUES. RESISTANCE WAS ENCOUNTERED WHEN ADVANCING THE DEVICE. IT WAS REPORTED THAT THE DEVICE KINKED IN THE MIDDLE WHILE IN THE PATIENT. AN IMAGE OF THE DEVICE RECEIVED SHOWED THAT THE DEVICE WAS TORSIONALLY KINKED. THE PATIENT IS ALIVE WITH NO INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8703008 ↗
• InjuryJul 26, 2018Adverse Event Without Identified Device or Use Problem

  DURING INDEX PROCEDURE ONE RESOLUTE ONYX DES WAS IMPLANTED IN THE 1ST OBTUSE MARGINAL AND A LAUNCHER GUIDE CATHETER WAS USED, WHICH CAUSED A DISSECTION.

  Patient problems: Intimal Dissection; Vascular Dissection

  MAUDE report 7721537 ↗

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-1247-2021 · Jan 15, 2021 · Terminated
  Medtronic 6F Launcher Guide Catheter 100cm EBU 3.75 Model Number: LA6EBU375
• Z-1248-2021 · Jan 15, 2021 · Terminated
  Medtronic 6F Launcher Guide Catheter 100 cm EBU 3.0 Model Number: LA6EBU30
• 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-0956-06 · Apr 5, 2006 · Terminated
  CATH. GUIDE 6F SR3.0 LAUNCHER CATHETER LA6SR30 LA 6F 100CM SR30 Coronary Guiding catheter designed to provide a pathway through which therapeutic and/or diagnostic devices are int
• 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-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-0967-06 · Apr 5, 2006 · Terminated
  CATH. GUIDE 6F SR6.0 LAUNCHER CATHETER LA6SR60 LA 6F 100CM SR60 Coronary Guiding catheter designed to provide a pathway through which therapeutic and/or diagnostic devices are int
• 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-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-0940-06 · Apr 5, 2006 · Terminated
  CATH. GUIDE 6F AL 2.0 110CM LA CATHETER LA6AL20A LA 6F 110CM AL20 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-0955-06 · Apr 5, 2006 · Terminated
  CATHETER LA6MB1A LA 6F 110CM M 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.