Launcher LA6JR35SHRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00613994817761), received between Mar 28, 2022 and Jul 17, 2023 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (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.

• MalfunctionJul 17, 2023Difficult to Insert; Difficult to Remove; Detachment of Device or Device Component; Difficult to Advance; Material Deformation; Material Split, Cut or Torn; Difficult to Insert; Difficult to Remove; Detachment of Device or Device Component; Difficult to Advance; Material Deformation; Material Split, Cut or Torn

  AN ATTEMPT WAS MADE TO USE ONE 6F LAUNCHER GUIDE CATHETER TO TREAT A MILDLY TORTUOUS, NON-CALCIFIED LESION WITH 99% STENOSIS IN THE MID RIGHT CORONARY ARTERY (RCA). THE DEVICE WAS INSPECTED WITH NO ISSUES NOTED. THE DEVICE WAS PREPPED PER IFU WITH NO ISSUES NOTED. RESISTANCE WAS ENCOUNTERED WHEN ADVANCING THE DEVICE. EXCESSIVE FORCE WAS NOT USED DURING INSERTION/DELIVERY. A FEMORAL APPROACH WAS USED. IT WAS REPORTED THAT RESISTANCE WAS EXPERIENCED DURING USE. RESISTANCE WAS FELT WHILE INSERTING AND ADVANCING THE NON-MEDTRONIC GUIDEWIRE. RESISTANCE WAS ALSO FELT WHEN REMOVING THE GUIDEWIRE FROM THE LAUNCHER. THE DEVICE WAS NOT EXCESSIVELY TORQUED. THE GUIDEWIRE WAS EXAMINED AND FLUSHED BEFORE USE WITH NO KINKS. FINAL RESULT WAS TIMI 3 FLOW. THE PATIENT IS ALIVE WITH NO INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17332855 ↗
• MalfunctionMar 28, 2022Difficult to Remove; Detachment of Device or Device Component; Material Deformation; Difficult to Remove; Detachment of Device or Device Component; Material Deformation

  DURING A PROCEDURE AN ATTEMPT WAS MADE TO USE ONE 6F LAUNCHER GUIDE CATHETER TO TREAT A LESION. THERE WAS NO DAMAGE TO THE PACKAGING. THE DEVICE WAS REMOVED FROM PACKAGING PER IFU WITH NO ISSUES NOTED. THE DEVICE WAS INSPECTED WITH NO ISSUES NOTED. THE DEVICE WAS PREPPED PER IFU WITH NO ISSUES. EXCESSIVE FORCE WAS NOT USED DURING INSERTION OR DELIVERY. IT WAS REPORTED THAT RESISTANCE WAS EXPERIENCED WHEN REMOVING THE DEVICE, AND THE TIP OF THE GUIDE CATHETER WAS NOTED TO BE PARTIALLY BROKEN. THE PATIENT IS ALIVE WITH NO INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13926274 ↗

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-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-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-0954-06 · Apr 5, 2006 · Terminated
  CATH. GUIDE 6F JR5.0 110CM LAU CATHETER LA6JR50A LA 6F 110CM JR50 Coronary Guiding catheter designed to provide a pathway through which therapeutic and/or diagnostic devices are i
• 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-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-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-0998-06 · Apr 5, 2006 · Terminated
  CATHETER SA6SR35 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-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
• 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-0967-06 · Apr 5, 2006 · Terminated
  CATH. GUIDE 6F SR6.0 LAUNCHER CATHETER LA6SR60 LA 6F 100CM SR60 Coronary Guiding catheter designed to provide a pathway through which therapeutic and/or diagnostic devices are int
• 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

…and 37 more.