Launcher LA6JL35 (UDI 00763000392345)Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00763000392345), received between Oct 11, 2023 and Oct 11, 2023 — classified as 1 injury.

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

• InjuryOct 11, 2023Material Deformation; Material Deformation

  AN ATTEMPT WAS MADE TO USE ONE LAUNCHER 6F GUIDE CATHETER DURING A PROCEDURE. THE DEVICE WAS NOT INSPECTED. THE DEVICE WAS PREPPED PER IFU WITH NO ISSUES NOTED. IT WAS REPORTED THAT THERE WAS DAMAGE TO THE MOUTH OF THE GUIDE CATHETER. IT WAS DETAILED THAT THE PATIENT SUFFERED A VASCULAR DISSECTION WHICH WAS TREATED WITH BALLOON OPPRESSION. THE GUIDE CATHETER WAS BEING USED DURING THE TREATMENT OF THE VASCULAR DISSECTION. THE DEFORMATION TO THE GUIDE CATHETER WAS NOTED DURING WITHDRAWAL OF THE DEVICE FROM THE PATIENT. IT COULD NOT BE DETERMINED IF THE GUIDE CATHETER CAUSED OR CONTRIBUTED TO THE VASCULAR DISSECTION. THE PATIENT IS CURRENTLY IN A STABLE CONDITION.

  Patient problems: Insufficient Information; Vascular Dissection

  MAUDE report 17911091 ↗

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-1247-2021 · Jan 15, 2021 · Terminated
  Medtronic 6F Launcher Guide Catheter 100cm EBU 3.75 Model Number: LA6EBU375
• Z-1246-2021 · Jan 15, 2021 · Terminated
  Medtronic 6F Launcher Guide Catheter 100 cm JR 4.0 Model Number: LA6JR40
• 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-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-0951-06 · Apr 5, 2006 · Terminated
  CATH. GUIDE 6F JL5.0 110CM LAU CATHETER LA6JL50A LA 6F 110CM JL50 Coronary Guiding catheter designed to provide a pathway through which therapeutic and/or diagnostic devices are i
• 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-0961-06 · Apr 5, 2006 · Terminated
  CATHETER LA6SR40A 6F 110CM SR4 CATHETER LA6SR40A 6F 110CM SR40 Coronary Guiding catheter designed to provide a pathway through which therapeutic and/or diagnostic devices are intr
• 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-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-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-0946-06 · Apr 5, 2006 · Terminated
  CATH. GUIDE 6F JL3.5 110CM LAU CATHETER LA6JL35A LA 6F 110CM JL35 Coronary Guiding catheter designed to provide a pathway through which therapeutic and/or diagnostic devices are i
• 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-0997-06 · Apr 5, 2006 · Terminated
  CATHETER SA63DRCSH Coronary Guiding catheter designed to provide a pathway through which therapeutic and/or diagnostic devices are introduced into the coronary or peripheral vascu

…and 37 more.