LAUNCHER LA6JR35 (UDI 00763000705534)Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00763000705534), received between May 21, 2024 and May 21, 2024 — classified as 1 injury.

The most frequently reported specific device problem is “Difficult to Remove” (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 21, 2024Difficult to Remove; Material Deformation; Difficult to Remove; Material Deformation

  DURING A CORONARY ANGIOGRAM PROCEDURE AN ATTEMPT WAS MADE TO USE ONE 6F LAUNCHER GUIDE CATHETER IN AN ATTEMPT TO ENGAGE THE RIGHT CORONARY ARTERY (RCA). IT WAS REPORTED THAT THE GUIDE CATHETER AND WIRE SLIPPED BACK FROM THE AORTA TO THE PATIENT'S RIGHT FOREARM. ON XRAY THE GUIDE CATHETER COULD BE SEEN TO HAVE A KNOT IN IT AND WAS STUCK IN THE PATIENT, CAUSING PAIN WITH ANY PUSHING AND PULLING. INTERVENTIONAL RADIOLOGY (IR) SERVICE WAS CONTACTED TO COME AND TAKE A LOOK AT THE RETAINED KNOTTED CATHETER. AN ULTRASOUND WAS CARRIED OUT ON THE AFFECTED VESSEL AND BELOW THE CATHETER KNOT SHOWED GOOD ARTERIAL BLOOD FLOW PROXIMAL TO THE KNOT AND COULD SEE THAT THE KNOT WAS TIGHTLY WEDGED INTO PLACE IN THE ARTERY. SURGERY WAS DEEMED NECESSARY AND FEMORAL ACCESS OF THE RIGHT FEMORAL ARTERY WAS OBTAINED TO COMPLETE AN ANGIOGRAM OF THE RIGHT ARM FOR ANATOMICAL IMAGING. THE PATIENT WAS THEN TAKEN OFF THE TABLE AND BROUGHT TO THE OPERATING ROOM (OR) FOR POSSIBLE CUT DOWN AND REMOVAL OF THE RETAINED CATHETER. GRAFT HARVEST TECHNIQUE FROM THE LEG WAS ATTEMPTED, WHICH DID NOT REMAIN PATENT BUT WAS ENSURED THAT ADEQUATE PERFUSION OF THE DISTAL EXTREMITY WAS OBTAINED. THE PATIENT HAS CONTINUED TO HAVE

  Patient problems: Insufficient Information; Pain

  MAUDE report 19358703 ↗

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-1248-2021 · Jan 15, 2021 · Terminated
  Medtronic 6F Launcher Guide Catheter 100 cm EBU 3.0 Model Number: LA6EBU30
• Z-1247-2021 · Jan 15, 2021 · Terminated
  Medtronic 6F Launcher Guide Catheter 100cm EBU 3.75 Model Number: LA6EBU375
• Z-1246-2021 · Jan 15, 2021 · Terminated
  Medtronic 6F Launcher Guide Catheter 100 cm JR 4.0 Model Number: LA6JR40
• 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-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-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-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-0940-06 · Apr 5, 2006 · Terminated
  CATH. GUIDE 6F AL 2.0 110CM LA CATHETER LA6AL20A LA 6F 110CM AL20 Coronary Guiding catheter designed to provide a pathway through which therapeutic and/or diagnostic devices are i
• 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
• Z-0959-06 · Apr 5, 2006 · Terminated
  CATH. GUIDE 6F SR3.5 W/SH LAUN CATHETER LA6SR35SH LA 6F 100CM SR35 Coronary Guiding catheter designed to provide a pathway through which therapeutic and/or diagnostic devices are
• Z-0953-06 · Apr 5, 2006 · Terminated
  CATH.GUIDE 6F JR 4.0 SH 110CM CATHETER LA6JR40SHA LA 6F 110CM JR40 Coronary Guiding catheter designed to provide a pathway through which therapeutic and/or diagnostic devices are
• 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-0949-06 · Apr 5, 2006 · Terminated
  CATH.GUIDE 6F JL 4.0 SH 110CM CATHETER LA6JL40SHA LA 6F 110CM JL40 Coronary Guiding catheter designed to provide a pathway through which therapeutic and/or diagnostic devices are

…and 37 more.