Launcher LA6SAL10Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00763000393588), received between Jul 25, 2023 and Jul 25, 2023 — classified as 1 malfunction.

The most frequently reported specific device problem is “Deformation Due to Compressive Stress” (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.

• MalfunctionJul 25, 2023Deformation Due to Compressive Stress; Material Deformation; Material Split, Cut or Torn; Deformation Due to Compressive Stress; Material Deformation; Material Split, Cut or Torn

  AN ATTEMPT WAS MADE TO USE ONE 6F LAUNCHER GUIDE CATHETER DURING A PERCUTANEOUS CORONARY STENT IMPLANTATION FOR CORONARY HEART DISEASE. AN ANGIOGRAM SHOWED SCATTERED PLAQUES IN THE 1-2 SEGMENTS OF THE RIGHT CORONARY ARTERY (RCA) WITH 30-40% STENOSIS AND SOFT PLAQUES AT THE END OF THE 3RD SEGMENT WITH 70-80% STENOSIS. ABOUT 80-90% LOCALIZED STENOSIS WAS SEEN IN THE PROXIMAL /MID OF THE POSTERIOR DESCENDING ARTERY AND THE DISTAL BLOOD FLOW WAS TIMI3. DAMAGE WAS NOT EVIDENT TO THE PROTECTIVE PACKAGING OF THE DEVICE. RESISTANCE WAS NOT NOTED WHILE REMOVING THE DEVICE FROM THE PACKAGING. THE DEVICE WAS INSPECTED AFTER REMOVAL FROM THE PACKAGING WITH NO ISSUES NOTED. RESISTANCE WAS NOTED DURING THE INSERTION/DELIVERY OF THE DEVICE. EXCESSIVE FORCE WAS NOT USED DURING THE DELIVERY OF THE DEVICE. THE DEVICE WAS NOT EXCESSIVELY TORQUED. THE GUIDE CATHETER WAS INSERTED INTO THE RCA VIA A RADIAL APPROACH. IT WAS REPORTED THAT DURING DELIVERY THE CATHETER WAS GENTLY ROTATED AND A TORSION MARK ON THE CATHETER WAS NOTED. UNABLE TO REBOUND AFTER ROTATION, THE LUMEN WAS TOO NARROW, AND THE NON-MEDTRONIC GUIDEWIRE COULD NOT PASS THROUGH THE GUIDE CATHETER. THE GUIDEWIRE HAD NOT YET BEEN USED IN THE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17388811 ↗

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-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-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-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-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-0939-06 · Apr 5, 2006 · Terminated
  CATH. GUIDE 6F AL 1.0 110CM LA CATHETER LA6AL10A LA 6F 110CM AL10 Coronary Guiding catheter designed to provide a pathway through which therapeutic and/or diagnostic devices are i
• Z-0941-06 · Apr 5, 2006 · Terminated
  CATH GUIDE 6F LAUNCHER AL 3.0 CATHETER LA6AL30A LA 6F 110CM AL30 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-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-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-0950-06 · Apr 5, 2006 · Terminated
  CATHETER LA6JL45A 6F 110CM JL4 CATHETER LA6JL45A 6F 110CM JL45 Coronary Guiding catheter designed to provide a pathway through which therapeutic and/or diagnostic devices are intr
• Z-0965-06 · Apr 5, 2006 · Terminated
  CATH. GUIDE 6F SR5.0 LAUNCHER CATHETER LA6SR50 LA 6F 100CM SR50 Coronary Guiding catheter designed to provide a pathway through which therapeutic and/or diagnostic devices are int

…and 37 more.