Launcher LA6JL35 (UDI 00613994818157)Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00613994818157), received between Jun 8, 2017 and Aug 23, 2021 — classified as 1 injury, 3 malfunctions.

The most frequently reported specific device problem is “Material Deformation” (2 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 23, 2021Use of Device Problem; Use of Device Problem

  A LAUNCHER GUIDE CATHETER WAS USED IN THE PATIENT. IT WAS REPORTED THAT THE PRODUCT WAS EXPIRED. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12353641 ↗
• InjuryJun 3, 2021Material Deformation; Material Deformation

  DURING A PROCEDURE AN ATTEMPT WAS MADE TO USE ONE LAUNCHER GUIDE CATHETER TO TREAT A LESION. IT WAS REPORTED THAT WHEN PERCUTANEOUS CORONARY BALLOON DILATATION WAS PERFORMED THE LAUNCHER GUIDE CATHETER WAS KINKED WHEN IT WAS USED TO PASS THROUGH THE BLOOD VESSEL,AND THE LOCAL CATHETER WAS TWISTED IN KNOTS. IT WAS UNTIED BY ROTATING AND THE CATHETER WAS TAKEN OUT. ANOTHER GUIDE CATHETER WAS USED TO CONTINUE THE OPERATION. THE PATIENT EXPERIENCED VASCULAR INJURY.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 11928819 ↗
• MalfunctionDec 15, 2020Material Deformation; Material Deformation

  DURING A PROCEDURE, TWO 6 FRENCH LAUNCHER GUIDE CATHETERS WERE INTENDED TO BE USED. THERE WAS NO DAMAGE NOTED TO THE PACKAGING. THE DEVICES WERE REMOVED FROM PACKAGING AND PREPPED PER IFU WITH NO ISSUES NOTED. THE DEVICES WERE INSPECTED WITH NO ISSUES NOTED. EXCESSIVE FORCE WAS NOT USED DURING INSERTION. RESISTANCE WAS NOT NOTED WHEN ADVANCING THE SECOND GUIDE CATHETER (LOT#: 0010259138). IT WAS REPORTED THAT BOTH GUIDE CATHETERS WERE KINKED. IT WAS STATED THAT THE KINK WAS NOTED ON THE FIRST GUIDE CATHETER (LOT#: 0009935514) DURING INSERTION OF THE DEVICE INTO THE PATIENT. IT WAS STATED THAT THE SECOND GUIDE CATHETER (LOT#: 0010259138) WAS NOTED TO BE KINKED BEFORE USE IN THE PATIENT. IT WAS INDICATED THAT ONE KINK WAS PROXIMAL AND THE OTHER WAS DISTAL. THE PROCEDURE WAS COMPLETED USING ANOTHER LAUNCHER GUIDE CATHETER. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11011246 ↗
• MalfunctionJun 8, 2017Device Expiration Issue; Device Expiration Issue

  THE LAUNCHER GUIDE CATHETER WAS REMOVED FROM PACKAGING. THE INSTRUCTIONS FOR USE WERE NOT ADHERED TO. NO DAMAGE WAS NOTED TO THE PACKAGING. THE DEVICE WAS INSPECTED AND PREPPED WITH NO ISSUES NOTED. NO RESISTANCE WAS ENCOUNTERED ADVANCING THE DEVICE, EXCESSIVE FORCE WAS NOT APPLIED DURING INSERTION/ DELIVERY. IT IS REPORTED THAT THE PRODUCT WAS USED PAST ITS USE BY DATE. NO INJURY CAUSED TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6622133 ↗

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-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-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-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-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-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-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-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-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
• 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-0960-06 · Apr 5, 2006 · Terminated
  CATH. GUIDE 6F SR4.0 LAUNCHER CATHETER LA6SR40 LA 6F 100CM SR40 Coronary Guiding catheter designed to provide a pathway through which therapeutic and/or diagnostic devices are int
• Z-0945-06 · Apr 5, 2006 · Terminated
  CATHETER LA6HSIA 6F 110CM HSI Coronary Guiding catheter designed to provide a pathway through which therapeutic and/or diagnostic devices are introduced into the coronary or perip

…and 37 more.