Launcher LA6AL10 (UDI 00763000508203)Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00763000508203), received between Nov 4, 2022 and Nov 4, 2022 — 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.

• InjuryNov 4, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING THE INDEX PROCEDURE ONE ONYX FRONTIER DRUG ELUTING STENT WAS IMPLANTED IN THE RCA. ONE LAUNCHER GUIDE CATHETER AND ONE NC EUPHORA BALLOON WERE ALSO USED DURING THE PROCEDURE. DURING THE PROCEDURE A DISSECTION OCCURRED IN THE RCA. THE DISSECTION HAD A SMALL RADIOLUCENT AREA WITHIN THE LUMEN OF THE VESSEL DISAPPEARING WITH THE PASSAGE OF THE CONTRAST MATERIAL. THE SITE STATED THAT NO MEDTRONIC DEVICE WAS THE CAUSE OF DISSECTION. THE SPONSOR CONSERVATIVELY ASSESSED THE EVENT AS POSSIBLY RELATED TO THE DEVICE AND PROCEDURE.

  Patient problems: Vascular Dissection

  MAUDE report 15724518 ↗

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-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-0952-06 · Apr 5, 2006 · Terminated
  CATH. GUIDE 6F JR4.0 110CM LAU CATHETER LA6JR40A LA 6F 110CM JR40 Coronary Guiding catheter designed to provide a pathway through which therapeutic and/or diagnostic devices are i
• 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-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-0999-06 · Apr 5, 2006 · Terminated
  CATHETER SA6SR40 SA 6F 100CM Coronary Guiding catheter designed to provide a pathway through which therapeutic and/or diagnostic devices are introduced into the coronary or perip
• 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-0941-06 · Apr 5, 2006 · Terminated
  CATH GUIDE 6F LAUNCHER AL 3.0 CATHETER LA6AL30A LA 6F 110CM AL30 Coronary Guiding catheter designed to provide a pathway through which therapeutic and/or diagnostic devices are in
• 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
• 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
• Z-0963-06 · Apr 5, 2006 · Terminated
  CATH. GUIDE 6F SR4.5 LAUNCHER CATHETER LA6SR45 LA 6F 100CM SR45 Coronary Guiding catheter designed to provide a pathway through which therapeutic and/or diagnostic devices are int

…and 37 more.