Launcher LA6EBU375 (UDI 00613994821348)Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00613994821348), received between Feb 25, 2020 and Mar 26, 2021 — 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.

• InjuryMar 26, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  ONE 6F LAUNCHER GUIDE CATHETER WAS ATTEMPTED TO BE USED DURING A CORONARY ANGIOPLASTY PROCEDURE IN A NON-CALCIFIED VESSEL. THERE WAS NO DAMAGE NOTED TO THE DEVICE PACKAGING. THE DEVICE WAS REMOVED FROM THE PACKAGING AS PER IFU WITH NO ISSUES NOTED. IT WAS REPORTED THAT THE GUIDE CATHETER BROKE. AN ATTEMPT WAS MADE TO RECOVER THE GUIDE CATHETER FRAGMENT PERCUTANEOUSLY VIA THE SAME INITIAL RADIAL ROUTE, THEN VIA THE RIGHT FEMORAL ROUTE WITH A SNARE BUT BOTH WERE UNSUCCESSFUL. THE CATHETER FRAGMENT WAS THEN REMOVED BY A SURGICAL APPROACH UNDER LOCAL ANESTHESIA. NO FURTHER PATIENT INJURY REPORTED.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 11573620 ↗
• InjuryFeb 25, 2020Difficult to Remove; Material Deformation; Material Twisted/Bent; Difficult to Remove; Material Deformation; Material Twisted/Bent

  A LAUNCHER GUIDE CATHETER WAS INTENDED TO BE USED DURING A PROCEDURE. NO DAMAGE WAS NOTED TO PACKAGING. THE DEVICE WAS REMOVED FROM PACKAGING PER IFU. THE DEVICE WAS INSPECTED AND PREPPED PER IFU WITH NO ISSUES NOTED. IT WAS REPORTED THAT THE LAUNCHER STRETCHED AND CHANGED SHAPE DURING THE PROCEDURE. THE DEVICE WAS DAMAGED DURING INTUBATION ATTEMPT OF LEFT CORONARY ARTERY. THERE WAS NO OBVIOUS ANATOMICAL PROBLEM. NO SIGNIFICANT FORCE WAS USED TO ROTATE THE CATHETER. A CRACK WAS NOTED FOLLOWED BY ROTATION PROBLEMS. ATTEMPT OF REINTRODUCING THE GUIDEWIRE FAILED. FLUORO SHOWED THE BROKEN CATHETER LOW AT THE LEVEL OF THE DISTAL ABDOMINAL AORTA. ATTEMPT TO ROTATE AND STRAIGHTEN THE BROKEN PART FAILED AS WELL. RETRACTION TO FEMORAL SHEATH AND ATTEMPT TO REMOVE THE DEVICE THROUGH IT FAILED. TO AVOID LOSING THE DISTAL PART OF CATHETER WITH EXTENSIVE FORCE APPLIED, THE LAUNCHER DEVICE WITH THE SHEATH WERE REMOVED ALL TOGETHER AND IT WAS SUCCESSFUL. PATIENT REQUIRED PROTAMINE SULPHATE INFUSION AND PROLONGED MANUAL COMPRESSION OF PUNCTURE SITE. THE PATIENT IS ALIVE WITH NO INJURY

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9749526 ↗

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-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-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-0962-06 · Apr 5, 2006 · Terminated
  CATH. GUIDE 6F SR4.0 W/SH LAUN CATHETER LA6SR40SH LA 6F 100CM SR40 Coronary Guiding catheter designed to provide a pathway through which therapeutic and/or diagnostic devices are
• Z-0961-06 · Apr 5, 2006 · Terminated
  CATHETER LA6SR40A 6F 110CM SR4 CATHETER LA6SR40A 6F 110CM SR40 Coronary Guiding catheter designed to provide a pathway through which therapeutic and/or diagnostic devices are intr
• 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-1001-06 · Apr 5, 2006 · Terminated
  CATHETER SB63DRC SB 6F 100CM 3 CATHETER SB63DRC SB 6F 100CM 3DRC Coronary Guiding catheter designed to provide a pathway through which therapeutic and/or diagnostic devices are in
• 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-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-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-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-0938-06 · Apr 5, 2006 · Terminated
  CATH. GUIDE 6F 3DRC W/SH LAUNC CATHETER LA63DRCSH LA 6F 100CM 3DRC Coronary Guiding catheter designed to provide a pathway through which therapeutic and/or diagnostic devices are

…and 37 more.