Launcher LA6JL40 (UDI 00763000392390)Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00763000392390), received between Dec 11, 2023 and Dec 15, 2023 — classified as 1 death, 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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryDec 15, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING THE INDEX PROCEDURE TWO PREVAIL DRUG COATED BALLOONS WERE USED, ONE WAS USED TO TREAT A LESION IN THE 2ND DIAGONAL AND THE SECOND WAS USED TO TREAT A LESION IN THE LEFT ANTERIOR DESCENDING ARTERY (LAD). FOUR LAUNCHER GUIDE CATHETERS WERE ALSO USED DURING THE PROCEDURE. DURING THE PROCEDURE A DISSECTION OCCURRED. A SMALL RADIOLUCENT AREA WITHIN THE LUMEN OF THE VESSEL DISAPPEARING WITH THE PASSAGE OF THE CONTRAST MATERIAL WAS NOTED. IT WAS NOT BELIEVED THAT A MEDTRONIC DEVICE WAS THE CAUSE OF THE DISSECTION BUT IT WAS NOT KNOWN WHICH DEVICE CAUSED THE DISSECTION. IT WAS ALSO REPORTED THAT DURING THE PROCEDURE A SIDE BRANCH OCCLUSION OCCURRED IN THE 2ND DIAGONAL. THE PATIENT WAS DISCHARGED.

  Patient problems: Obstruction/Occlusion; Vascular Dissection

  MAUDE report 18333615 ↗
• DeathDec 11, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING THE INDEX PROCEDURE TWO PREVAIL DRUG COATED BALLOONS WERE USED, ONE WAS USED TO TREAT A LESION IN THE 2ND DIAGONAL AND THE SECOND WAS USED TO TREAT A LESION IN THE LEFT ANTERIOR DESCENDING ARTERY (LAD). FOUR LAUNCHER GUIDE CATHETERS WERE ALSO USED DURING THE PROCEDURE. DURING THE PROCEDURE A DISSECTION WAS OBSERVED AND A SIDE BRANCH OCCLUSION ALSO OCCURRED IN THE 2ND DIAGONAL ARTERY. APPROXIMATELY 3 DAYS POST PROCEDURE THE PATIENT DIED FROM AN UNKNOWN CAUSE. THE DEATH CLASSIFICATION WAS UNKNOWN. THE AE WAS ASSOCIATED WITH A MYOCARDIAL INFARCTION. THE PATIENT WAS NOT TAKING DUAL ANTIPLATELET THERAPY WITHIN 24 HOURS PRIOR TO THE EVENT.

  Patient problems: Aortic Valve Stenosis; Insufficient Information; Ischemia; Myocardial Infarction; Pneumonia

  MAUDE report 18299405 ↗

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-1246-2021 · Jan 15, 2021 · Terminated
  Medtronic 6F Launcher Guide Catheter 100 cm JR 4.0 Model Number: LA6JR40
• 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-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-1003-06 · Apr 5, 2006 · Terminated
  CATHETER SB6SR30 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-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-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-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-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-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-0947-06 · Apr 5, 2006 · Terminated
  CATH. GUIDE 6F JL4.0 5 PACK LA Coronary Guiding catheter designed to provide a pathway through which therapeutic and/or diagnostic devices are introduced into the coronary or peri
• 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

…and 37 more.