Launcher LA6AL10 (UDI 00613994820327)Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00613994820327), received between Jun 13, 2018 and Feb 4, 2019 — classified as 2 injuries.

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

• InjuryFeb 4, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  A LAUNCHER DEVICE WAS INTENDED TO BE USED DURING A PROCEDURE. NO DAMAGE NOTED TO PACKAGING. NO ISSUES WHEN REMOVING THE DEVICE FROM THE PACKAGING AS PER IFU. THE DEVICE WAS INSPECTED AND PREPPED AS PER IFU WITH NO ISSUES. IT IS REPORTED THAT THE DEVICE BROKE OFF WHILE IN THE AORTA. NO RESISTANCE WAS ENCOUNTERED WHEN ADVANCING THE DEVICE, NO EXCESSIVE FORCE WAS USED DURING DELIVERY. IT IS REPORTED THAT THE PATIENT HAS BEEN MOVED FOR SURGERY TO REMOVE THE CATHETER. NO FURTHER PATIENT INJURY REPORTED.

  Patient problems: Patient Problem/Medical Problem

  MAUDE report 8301251 ↗
• InjuryJun 13, 2018Entrapment of Device; Material Deformation; Entrapment of Device; Material Deformation

  A 6F LAUNCHER GUIDE CATHETER WAS ATTEMPTED TO BE USED IN A PROCEDURE TO TREAT A MODERATELY TORTUOUS LESION IN THE RCA. THERE WAS NO DAMAGE NOTED TO THE DEVICE PACKAGING. THERE WERE NO ISSUES WHEN REMOVING THE DEVICE FROM THE PACKAGING. THE DEVICE WAS INSPECTED WITH NO ISSUES. THE DEVICE WAS PREPPED PER IFU WITH NO ISSUES. THE LESION WAS PRE-DILATED TO 22 ATM USING A NON-MEDTRONIC SC BALLOON CATHETER. RESISTANCE WAS ENCOUNTERED WHEN ADVANCING THE DEVICE. IT IS REPORTED THAT THE PHYSICIAN TRIED TO DELIVER A NON-MEDTRONIC DRUG ELUTING STENT THROUGH THE GUIDE CATHETER BUT THE STENT GOT LODGED AND WOULD NOT MOVE. THE STENT TIP DID NOT EXIT THE TIP OF THE GUIDE CATHETER AT ANY STAGE. THE PHYSICIAN THEN REMOVED THE WHOLE SYSTEM, BY WITHDRAWING THE GUIDE WITH THE STENT INSIDE, RESULTING IN A DISSECTION OF THE RCA. NO INTERVENTION WAS REQUIRED. THE PROCEDURE WAS THEN ABANDONED, AND NO ADDITIONAL TREATMENT WAS PERFORMED. THE PHYSICIAN IS UNSURE WHAT THE ADVERSE EVENT IS RELATED TO. THE PATIENT IS REPORTED AS BEING STABLE POST-PROCEDURE.

  Patient problems: Vascular Dissection

  MAUDE report 7595352 ↗

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-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-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-0968-06 · Apr 5, 2006 · Terminated
  CATH. GUIDE 6F SR6.0 W/SH LAUN Coronary Guiding catheter designed to provide a pathway through which therapeutic and/or diagnostic devices are introduced into the coronary or peri
• 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
• 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-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-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-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-0958-06 · Apr 5, 2006 · Terminated
  CATH. GUIDE 6F SR3.5 LAUNCHER CATHETER LA6SR35 LA 6F 100CM SR35 Coronary Guiding catheter designed to provide a pathway through which therapeutic and/or diagnostic devices are int
• Z-0939-06 · Apr 5, 2006 · Terminated
  CATH. GUIDE 6F AL 1.0 110CM LA CATHETER LA6AL10A LA 6F 110CM AL10 Coronary Guiding catheter designed to provide a pathway through which therapeutic and/or diagnostic devices are i
• Z-0967-06 · Apr 5, 2006 · Terminated
  CATH. GUIDE 6F SR6.0 LAUNCHER CATHETER LA6SR60 LA 6F 100CM SR60 Coronary Guiding catheter designed to provide a pathway through which therapeutic and/or diagnostic devices are int

…and 37 more.