Launcher LA6JR405Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00613994817785), received between Aug 4, 2023 and Aug 4, 2023 — classified as 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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryAug 4, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING THE INDEX PROCEDURE ONE RESOLUTE ONYX DRUG ELUTING STENT WAS IMPLANTED IN THE RIGHT CORONARY ARTERY (RCA). DURING THE INDEX P PROCEDURE, ONE LAUNCHER GUIDE CATHETER AND ONE EXPORT AP ASPIRATION CATHETER WERE ALSO USED. DURING THE PROCEDURE THE PATIENT WAS UNDERGOING THROMBUS ASPIRATION, WHICH REMOVED A LOT OF RED THROMBUS AND RESTORED NICE FLOW. THE ASPIRATION CATHETER WAS ABLE TO ASPIRATE THE THROMBUS. HOWEVER THE PATIENT BECAME BRADYCARDIC AND HYPOTENSIVE. THE PATIENT WAS TREATED WITH MEDICATION AND IV FLUIDS. THE PATIENTS BLOOD PRESSURE RESPONDED WELL. THE PATIENT WAS ALSO TREATED WITH A PERCUTANEOUS TRANSLUMINAL CORONARY INTERVENTION. THE PATIENT WAS TAKING DUAL ANTIPLATELET THERAPY WITHIN 24 HOURS PRIOR TO THE EVENT. THE PATIENT RECOVERED. IT WAS STATED THAT THE RATIONALE FOR THE RELATIONSHIP TO THE SYSTEM OR PROCEDURE WAS THAT THE PATIENT WAS EXPERIENCING STEMI WITH A HIGH THROMBUS BURDEN IN THE PROXIMAL RCA.

  Patient problems: Bradycardia; Insufficient Information; Low Blood Pressure/ Hypotension; Myocardial Infarction; Thrombosis/Thrombus

  MAUDE report 17457564 ↗

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-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-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-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-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-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-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-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-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-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-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-0948-06 · Apr 5, 2006 · Terminated
  CATH. GUIDE 6F JL4.0 110CM LAU CATHETER LA6JL40A LA 6F 110CM JL40 Coronary Guiding catheter designed to provide a pathway through which therapeutic and/or diagnostic devices are i
• 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

…and 37 more.