Launcher LA6EBU35SHRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00613994821324), received between Jul 21, 2017 and Jul 23, 2020 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Material Deformation” (2 reports).

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.

• MalfunctionJul 23, 2020Material Deformation; Material Deformation

  A 6F LAUNCHER GUIDE CATHETER AND A 2.75 X 30MM RESOLUTE INTEGRITY RX CORONARY, DRUG ELUTING STENT WERE USED DURING A PROCEDURE TO TREAT A LESION IN THE CX. IT WAS REPORTED THAT A THE 6F LAUNCHER GUIDE CATHETER PASSED THE TWO ROPES THAT WOULD BE USED IN THE CORONARIES OF THE CX. THE RESOLUTE INTEGRITY STENT WAS THEN PASSED. RESISTANCE WAS ENCOUNTERED BETWEEN THE STENT AND THE GUIDE CATHETER. IT WAS REPORTED THAT THE TOP OF THE GUIDE CATHETER WAS BENT/FOLDED IN ON ITS SELF. THE PATIENT IS ALIVE WITH NO INJURY. DUE TO THE PICTURE OF THE STENT BEEN PARTICULARLY INFLATED I TICKED YES TO COMPLAINT FOR THE STENT BUT THERE DOESN'T SEEM TO BE ANY ALLEGED ISSUE AGAINST THE STENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 10314188 ↗
• MalfunctionJul 21, 2017Kinked; Material Deformation; Kinked; Material Deformation

  THE PHYSICIAN INTENDED TO USE A LAUNCHER GUIDE CATHETER. THE DEVICE WAS INSPECTED PRIOR TO USE AND PREPPED WITH NO ISSUES NOTED. RESISTANCE WAS NOTED WHEN ADVANCING THE LAUNCHER IN THE VESSEL. EXCESSIVE FORCE WAS NOT USED. RESISTANCE WAS ENCOUNTERED WHEN A STANDARD SIZE GUIDE LINER WAS INSERTED INTO THE LAUNCHER GUIDE CATHETER AND THE GUIDE LINER COULD NOT BE ADVANCED. ON REMOVAL OF THE GUIDE LINER FROM THE GUIDE CATHETER, THE TIP OF THE GUIDE CATHETER WAS NOTED TO BE KINKED AND SPLIT. NO PATIENT INJURY REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6731820 ↗

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-1248-2021 · Jan 15, 2021 · Terminated
  Medtronic 6F Launcher Guide Catheter 100 cm EBU 3.0 Model Number: LA6EBU30
• 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-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-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-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-0943-06 · Apr 5, 2006 · Terminated
  CATH. GUIDE 6F EBU4.0 110CM LA CATHETER LA6EBU40A LA 6F 110CM EB40 Coronary Guiding catheter designed to provide a pathway through which therapeutic and/or diagnostic devices are
• 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-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-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-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-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-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.