LAUNCHER LA6EBU35 (UDI 00763000705374)Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00763000705374), received between Nov 7, 2023 and May 23, 2025 — classified as 2 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Deformation Due to Compressive Stress” (3 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryMay 23, 2025Deformation Due to Compressive Stress; Detachment of Device or Device Component; Material Deformation; Material Split, Cut or Torn; Deformation Due to Compressive Stress; Detachment of Device or Device Component; Material Deformation; Material Split, Cut or Torn

  IT WAS REPORTED THAT DURING A PROCEDURE INVOLVING ONE 6F LAUNCHER GUIDE CATHETER, THE DEVICE SNAPPED OFF IN THE PATIENT. THE DEVICE WAS SUBSEQUENTLY RETRIEVED AND REMOVED USING A SNARE. IT WAS NOTED THERE WAS DEFORMATION EVIDENT TO THE DEVICE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Insufficient Information

  MAUDE report 22076455 ↗
• InjurySep 3, 2024Difficult to Remove; Deformation Due to Compressive Stress; Difficult to Remove; Deformation Due to Compressive Stress

  AN ATTEMPT WAS MADE TO USE ONE 6F LAUNCHER GUIDE CATHETER, DURING A PROCEDURE. IT WAS REPORTED, THAT DURING A HEART CATHETERIZATION, A KINK OCCURRED TO THE SHEATH AND CATHETER. THAT REQUIRED A VASCULAR SURGERY INTERVENTION TO REMOVE THE DEVICE. NO FURTHER INJURY WAS REPORTED ON THE PATIENT.

  Patient problems: Insufficient Information

  MAUDE report 20123912 ↗
• MalfunctionJul 5, 2024Leak/Splash; Connection Problem; Leak/Splash; Connection Problem

  AN ATTEMPT WAS MADE TO USE ONE 6F LAUNCHER GUIDE CATHETER DURING A PROCEDURE. THE DEVICE WAS INSPECTED BEFORE USE WITH NO ISSUES NOTED. RESISTANCE WAS NOT NOTED WHILE ADVANCING THE DEVICE TO THE LESION. IT WAS REPORTED THAT THE GUIDE CATHETER WAS LEAKING BLOOD DURING USE. THE LEAKING WAS CAUSED BY A CONNECTION PROBLEM, AND THE LAUNCHER COULD NOT BE CONNECTED NORMALLY. IT WAS NOT POSSIBLE TO CONNECT THE NON-MEDTRONIC Y-VALVES. THE LEAK WAS NOTED DURING THE DEVICE AND Y-VALVE CONNECTION, AND THE BLOOD LEAKAGE WAS A RESULT OF THE CONNECTION ISSUES. THE USE OF THE LAUNCHER WAS STOPPED IMMEDIATELY. A NEW CATHETER AND NEW Y-VALVE WERE USED, WHICH WERE CONNECTED AND USED NORMALLY. INTERVENTION WAS NOT REQUIRED AS A RESULT OF THE EVENT. THERE WAS NO INJURY TO THE PATIENT.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 19678445 ↗
• MalfunctionJan 4, 2024Fracture; Deformation Due to Compressive Stress; Fracture; Deformation Due to Compressive Stress

  AN ATTEMPT WAS MADE TO USE ONE LAUNCHER 6F GUIDE CATHETER DURING A PROCEDURE. IT WAS REPORTED THAT THE GUIDE CATHETER WAS KINKED AT THE TIP AND THE GUIDE CATHETER FRACTURED. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18442599 ↗
• MalfunctionNov 7, 2023Leak/Splash; Device Difficult to Setup or Prepare; Leak/Splash; Device Difficult to Setup or Prepare

  AN ATTEMPT WAS MADE TO USE ONE LAUNCHER 6F GUIDE CATHETER DURING A PROCEDURE. IT WAS REPORTED THAT THE GUIDE CATHETER WAS LEAKING BLOOD DURING USE. NO HARM WAS REPORTED TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18083690 ↗

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-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-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-1002-06 · Apr 5, 2006 · Terminated
  CATHETER SB63DRCSH SB 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-1007-06 · Apr 5, 2006 · Terminated
  CATHETER SB6SR40SH SB 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-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-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-0996-06 · Apr 5, 2006 · Terminated
  CATHETER SA63DRC SA 6F 100CM 3 CATHETER SA63DRC SA 6F 100CM 3DRC Coronary Guiding catheter designed to provide a pathway through which therapeutic and/or diagnostic devices are in
• 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-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
• 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

…and 37 more.