Launcher LA6EBU355Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00613994820006), received between Aug 8, 2023 and Aug 17, 2023 — classified as 2 injuries.

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.

• InjuryAug 17, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING THE INDEX PROCEDURE ONE PREVAIL DRUG COATED BALLOON AND ONE LAUNCHER GUIDE CATHETER WERE BEING USED TO TREAT THE LEFT ANTERIOR DESCENDING ARTERY (LAD). DURING THE PROCEDURE EVIDENCE OF DISTAL EMBOLIZATION WAS NOTED IN THE PROXIMAL LAD.

  Patient problems: Embolism/Embolus

  MAUDE report 17562552 ↗
• InjuryAug 8, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING THE INDEX PROCEDURE TWO RESOLUTE ONYX DRUG ELUTING STENTS WERE IMPLANTED IN THE MID AND PROXIMAL LEFT ANTERIOR DESCENDING ARTERY (LAD). A LAUNCHER GUIDE CATHETER AND EXPORT AP ASPIRATION CATHETER WERE ALSO USED DURING THE PROCEDURE. DURING THE PROCEDURE THROMBUS EMBOLIZATION OCCURRED. USING THE LAUNCHER GUIDE CATHETER, A NON-MEDTRONIC (MDT) WIRE WAS PASSED THROUGH THE SUB TOTALLY OCCLUDED AREA INTO THE MAIN LAD. A 2.5 X 15MM BALLOON WAS USED TO PRE DILATE THE AREA OF STENOSIS TO RESTORE FLOW. HOWEVER, THERE WAS EVIDENCE OF THROMBUS EMBOLIZATION AND THERE WAS SLOW FLOW WHICH RESULTED IN A LOSS OF FLOW IN THE ARTERY. THEREFORE, THE SAME BALLOON WAS USED TO PERFORM LOW PRESSURE INFLATIONS TO RESTORE FLOW. THEN, AN EXPORT AP ASPIRATION CATHETER WAS USED TO PERFORM MULTIPLE RUNS, WITH NOT MUCH THROMBUS EXPORTED. A 3 X 26MM RESOLUTE ONYX DRUG ELUTING STENT WAS USED TO COVER THE AREA OF DISEASE AT NORMAL PRESSURES. THERE APPEARED TO BE AN AREA OF HAZINESS, AND POSSIBLY A DISTAL EDGE DISSECTION. THEREFORE, IT WAS ELECTED TO FURTHER STENT THIS AREA WITH A SECOND 2.5 X 15MM RESOLUTE ONYX STENT, AND THE SAME BALLOON WAS USED TO POST DILATE THE OVERLAP AREA. A 3 X 20MM NON-C COMPLIANT B

  Patient problems: Embolism/Embolus; Myocardial Infarction; Obstruction/Occlusion; Thrombosis/Thrombus; Vascular Dissection

  MAUDE report 17479212 ↗

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-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-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-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-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-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-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-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-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-0954-06 · Apr 5, 2006 · Terminated
  CATH. GUIDE 6F JR5.0 110CM LAU CATHETER LA6JR50A LA 6F 110CM JR50 Coronary Guiding catheter designed to provide a pathway through which therapeutic and/or diagnostic devices are i
• Z-1006-06 · Apr 5, 2006 · Terminated
  CATHETER SB6SR40 SB 6F 100CM S CATHETER SB6SR40 SB 6F 100CM SR40 Coronary Guiding catheter designed to provide a pathway through which therapeutic and/or diagnostic devices are in
• 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.