Launcher LA6JR40SH (UDI 00763000391843)Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00763000391843), received between Oct 11, 2024 and Oct 11, 2024 — classified as 2 injuries.

The most frequently reported specific device problem is “Difficult to Remove” (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.

• InjuryOct 11, 2024Difficult to Remove; Material Deformation; Material Integrity Problem; Difficult to Remove; Material Deformation; Material Integrity Problem

  AN ATTEMPT WAS MADE TO USE ONE 6F LAUNCHER GUIDE CATHETER DURING A PROCEDURE. THERE WERE NO ABNORMALITIES IN THE ANATOMY. THERE WAS NO DAMAGE NOTED TO THE PACKAGING. RESISTANCE WAS NOT NOTED WHEN REMOVING THE DEVICE FROM THE PACKAGING. THERE WAS NO RESISTANCE NOTED WHEN INSERTING THE CATHETER. EXTREME FORCE WAS USED WHEN INSERTING AND DURING ATTEMPTED REMOVAL OF THE CATHETER. THE LAUNCHER WAS INSERTED INTO THE RIGHT FEMORAL ARTERY WITHOUT ANY PROBLEMS. IT WAS REPORTED THAT, IMMEDIATELY AFTER THE LAUNCHER CATHETER WAS BROUGHT INTO THE AORTIC ARCH, WHEN TRYING TO INTUBATE THE LAUNCHER INTO THE OSTIUM, THE LAUNCHER TWISTED OFF AFTER ONLY SLIGHT ROTATION OF THE CATHETER. THE LAUNCHER COULD NOT BE TURNED BACK AND COULD NO LONGER BE INTUBATED WITH THE WIRE. THE LAUNCHER COULD NOT BE MOVED AT ALL, EVEN WITH A LOT OF FORCE AND PULL. THERE WAS A RISK THE LAUNCHER WOULD TEAR OFF. THE ENTIRE LAUNCHER HAD TO BE REMOVED WITH THE SHEATH LYING DOWN. IT WAS POSSIBLE TO RECOVER THE ENTIRE LAUNCHER TOGETHER WITH THE INTRODUCER. THE ISSUE WITH THE LAUNCHER OCCURRED BEFORE INTERVENTION AT THE VESSEL. THE LAUNCHER SEEMED MUCH SOFTER THAN USUAL. THERE WAS NO KINKING NOTED TO THE CATHETER. NEW SHEATHS HA

  Patient problems: Insufficient Information

  MAUDE report 20426683 ↗
• InjuryOct 11, 2024Difficult to Remove; Material Deformation; Material Integrity Problem; Difficult to Remove; Material Deformation; Material Integrity Problem

  AN ATTEMPT WAS MADE TO USE ONE 6F LAUNCHER GUIDE CATHETER DURING A PROCEDURE. THERE WERE NO ABNORMALITIES IN THE ANATOMY. THERE WAS NO DAMAGE NOTED TO THE PACKAGING. RESISTANCE WAS NOT NOTED WHEN REMOVING THE DEVICE FROM THE PACKAGING. THERE WAS NO RESISTANCE NOTED WHEN INSERTING THE CATHETER. EXTREME FORCE WAS USED WHEN INSERTING AND DURING ATTEMPTED REMOVAL OF THE CATHETER. THE LAUNCHER WAS INSERTED INTO THE RIGHT FEMORAL ARTERY WITHOUT ANY PROBLEMS. IT WAS REPORTED THAT, IMMEDIATELY AFTER THE LAUNCHER CATHETER WAS BROUGHT INTO THE AORTIC ARCH, WHEN TRYING TO INTUBATE THE LAUNCHER INTO THE OSTIUM, THE LAUNCHER TWISTED OFF AFTER ONLY SLIGHT ROTATION OF THE CATHETER. THE LAUNCHER COULD NOT BE TURNED BACK AND COULD NO LONGER BE INTUBATED WITH THE WIRE. IT WAS POSSIBLE TO RECOVER THE LAUNCHER WITH A LOT OF FORCE AND TIME, HOWEVER, THIS RESULTED IN A COMPLETE DESTRUCTION OF THE LAUNCHER. THE DEVICE WAS NO LONGER USABLE. IT WAS POSSIBLE TO RECOVER THE ENTIRE LAUNCHER. THE ISSUE WITH THE LAUNCHER OCCURRED BEFORE INTERVENTION AT THE VESSEL. THE LAUNCHER SEEMED MUCH SOFTER THAN USUAL. THERE WAS NO KINKING NOTED TO THE CATHETER. NEW SHEATHS HAD TO BE CREATED ON THE OTHER SIDE, AND A NEW ME

  Patient problems: Insufficient Information

  MAUDE report 20426602 ↗

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-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-1005-06 · Apr 5, 2006 · Terminated
  CATHETER SB6SR35SH 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-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-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-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-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-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-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-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.