Launcher LA6EBU40SHRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00763000390570), received between May 2, 2024 and May 2, 2024 — classified as 1 injury.

The most frequently reported specific device problem is “Deformation Due to Compressive Stress” (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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryMay 2, 2024Deformation Due to Compressive Stress; Detachment of Device or Device Component; Deformation Due to Compressive Stress; Detachment of Device or Device Component

  THE PATIENT WAS ADMITTED AS AN EMERGENCY WITH A NON-ST SEGMENT ELEVATION MYOCARDIAL INFARCTION (NSTEMI), AND BLOCKAGE OF LEFT CIRCUMFLEX (LCX) ARTERY. AN ATTEMPT WAS MADE TO USE ONE LAUNCHER GUIDE CATHETER DURING A PROCEDURE. AFTER DIAGNOSTIC IMAGING, THE GUIDE CATHETER WAS INTRODUCED VIA A FEMORAL APPROACH, AS THE RADIAL APPROACH WAS NOT POSSIBLE. IT WAS REPORTED THAT A CATHETER DETACHMENT OCCURRED IN VIVO, AND THE CATHETER WAS KINKED. AFTER RELATIVELY SLIGHT TURNING (TORQUING) OF THE CATHETER TO TARGET THE LEFT OSTIUM THERE WAS A SUDDEN LOSS OF RESISTANCE. THE GUIDEWIRE COULD NOT BE PASSED THROUGH AND AFTER FURTHER IMAGING IT SHOWED THAT THE CATHETER WAS DISCONNECTED/SEVERED/SEPARATED AROUND 20CM FROM THE DISTAL END. THE DETACHED PORTION WAS RECOVERED USING A SNARE CATHETER AND A SECOND GUIDEWIRE THROUGH THE SHEATH. WITH AN 8F SHEATH AND USING THE SELDINGER TECHNIQUE IT WAS POSSIBLE TO SUCCESSFULLY FINISH THE ORIGINALLY INTENDED INTERVENTION. A LARGE HEMATOMA DEVELOPED IN THE GROIN REGION AND AN ANEURYSM WHICH HAD DEVELOPED WAS SUTURED THE FOLLOWING DAY. IT WAS ALSO REPORTED ANOTHER CATHETER SHOWED A KINK AT AROUND THE SAME POSITION AT 20CM FROM THE DISTAL END. THE PACKAGE OF THE

  Patient problems: Aneurysm; Hematoma; Insufficient Information

  MAUDE report 19229315 ↗

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-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-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-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-0946-06 · Apr 5, 2006 · Terminated
  CATH. GUIDE 6F JL3.5 110CM LAU CATHETER LA6JL35A LA 6F 110CM JL35 Coronary Guiding catheter designed to provide a pathway through which therapeutic and/or diagnostic devices are i
• 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-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-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-0966-06 · Apr 5, 2006 · Terminated
  CATH. GUIDE 6F SR5.0 W/SH LAUN CATHETER LA6SR50SH LA 6F 100CM SR50 Coronary Guiding catheter designed to provide a pathway through which therapeutic and/or diagnostic devices are
• 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-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-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

…and 37 more.