Launcher LA6JR50SHRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00613994817693), received between Jun 23, 2022 and Jun 23, 2022 — classified as 1 malfunction.

The most frequently reported specific device problem is “Leak/Splash” (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 18, 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.

• MalfunctionJun 23, 2022Leak/Splash; Material Puncture/Hole; Material Deformation; Leak/Splash; Material Puncture/Hole; Material Deformation

  AN ATTEMPT WAS MADE TO USE ONE 6F LAUNCHER GUIDE CATHETER TO TREAT A LESION WITH NO IRREGULAR CALCIFICATION IN THE RIGHT CORONARY ARTERY (RCA). THERE WAS NO DAMAGE NOTED TO THE PACKAGING. THE DEVICE WAS REMOVED FROM THE PACKAGE PER IFU WITH NO ISSUES NOTED. THE DEVICE WAS INSPECTED WITH NO ISSUES NOTED. THE DEVICE WAS PREPPED PER IFU WITH NO ISSUES NOTED. RESISTANCE WAS NOT ENCOUNTERED WHEN ADVANCING THE DEVICE. EXCESSIVE FORCE WAS NOT USED DURING INSERTION/DELIVERY. IT WAS REPORTED THAT AT THE BEGINNING OF THE PROCEDURE A LEAK OCCURRED. IT WAS DETAILED THAT WHEN THE CATHETER HAD ENTERED THE PATIENT'S VASCULATURE BLOOD CAME OUT OF A HOLE IN THE PROXIMAL SHAFT. THE PROXIMAL SHAFT OF THE CATHETER DID NOT ENTER THE PATIENT'S VASCULATURE. WHEN THE LEAK WAS DETECTED, THE CATHETER WAS REPLACED BY ANOTHER LAUNCHER DEVICE WHICH WAS SUCCESSFULLY USED. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14785882 ↗

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-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-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-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-0955-06 · Apr 5, 2006 · Terminated
  CATHETER LA6MB1A LA 6F 110CM M Coronary Guiding catheter designed to provide a pathway through which therapeutic and/or diagnostic devices are introduced into the coronary or peri
• 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-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-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-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-0964-06 · Apr 5, 2006 · Terminated
  CATH. GUIDE 6F SR4.5 W/SH LAUN CATHETER LA6SR45SH LA 6F 100CM SR45 Coronary Guiding catheter designed to provide a pathway through which therapeutic and/or diagnostic devices are
• 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-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-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.