Launcher LA6MP1SHRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00613994819130), received between Mar 8, 2023 and Apr 26, 2024 — classified as 1 injury, 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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryApr 26, 2024Device Dislodged or Dislocated; Positioning Problem; Device Dislodged or Dislocated; Positioning Problem

  AN ATTEMPT WAS MADE TO USE ONE ONYX FRONTIER CORONARY DRUG ELUTING STENT (DES) TO TREAT A SEVERELY TORTUOUS, MODERATELY CALCIFIED LESION WITH 70% STENOSIS LOCATED IN THE PROXIMAL RIGHT CORONARY ARTERY (RCA). THE DEVICE WAS INSPECTED WITH NO ISSUES. NEGATIVE PREP WAS PERFORMED WITH NO ISSUES NOTED. THE LESION WAS PRE-DILATED. THE DEVICE DID NOT PASS THROUGH A PREVIOUSLY DEPLOYED STENT. RESISTANCE WAS ENCOUNTERED WHEN ADVANCING THE DEVICE. THE RCA OSTIUM WAS DIFFICULT TO ENGAGE WITH A LAUNCHER GUIDE CATHETER. IT WAS REPORTED THAT STENT DEFORMATION OCCURRED IN VIVO DURING POSITIONING/ADVANCEMENT. THE STENT WAS PARTIALLY ADVANCED INTO THE LESION WITH THE ASSISTANCE OF A NON MEDTRONIC GUIDE EXTENSION CATHETER BUT WAS UNABLE TO FULLY PASS THE LESION. THE DEVICE WOULD NOT DELIVER TO THE CALCIFIED PROXIMAL RCA. THE DEVICE WAS THEN STRETCHED AND PULLED OFF THE BALLOON COMING BACK INTO THE GUIDE CATHETER. ON PULLBACK THE STENT WAS NOTED TO HAVE ELONGATED AND PARTIALLY DISLODGED OFF THE BALLOON. EXCESSIVE FORCE WAS NOT DICTATED IN THIS CASE. THE STENT FELL OFF THE SYSTEM FULLY IN THE FOREARM, AND WAS RETRIEVED THROUGH THE SHEATH. THE PROCEDURE WAS THEN FINISHED. A NON-MEDTRONIC STENT WAS USED

  Patient problems: Insufficient Information

  MAUDE report 19190120 ↗
• MalfunctionMar 8, 2023Deformation Due to Compressive Stress; Deformation Due to Compressive Stress

  AN ATTEMPT WAS MADE TO USE TWO 6F LAUNCHER GUIDE CATHETERS TO TREAT A MILDLY TORTUOUS, MILDLY CALCIFIED LESION IN THE MID SAPHENOUS VEIN GRAFT (SVG). THE DEVICES WERE INSPECTED WITH NO ISSUES NOTED. THE DEVICES WERE PREPPED PER IFU WITH NO ISSUES NOTED. RESISTANCE WAS NOT ENCOUNTERED WHEN ADVANCING THE DEVICES. EXCESSIVE FORCE WAS NOT USED DURING INSERTION/DELIVERY OF THE DEVICES. WHEN THE FIRST CATHETER WAS ADVANCED OVER A 175 J GUIDEWIRE, NO KINK WAS NOTED. HOWEVER, IT WAS REPORTED THAT WHILE TORQUEING THE DEVICE A KINK AT THE PROXIMAL END TOWARDS THE HUB WAS NOTICED. THE DEVICE AS NOT EXCESSIVELY TORQUED. THE DEVICE WAS REPLACED WITH ANOTHER CATHETER WITH THE SAME LOT NUMBER. UPON ADVANCING THE SECOND DEVICE AND WHILE TORQUEING, A KINK WAS SEEN AT THE PROXIMAL END TOWARDS THE HUB. THE DEVICE AS NOT EXCESSIVELY TORQUED. THE DEVICE WAS REPLACED WITH ANOTHER LAUNCHER 6F WITH A DIFFERENT LOT NUMBER AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED. IT IS UNKNOWN IF THERE WERE ANY KINKS BEFORE USE WHICH WERE NOT NOTICED, OR IF THE KINKS OCCURRED WHEN THE DEVICES WERE TORQUED. THE PATIENT IS REPORTED TO BE ALIVE WITH NO INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16501764 ↗

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-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-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-0966-06 · Apr 5, 2006 · Terminated
  CATH. GUIDE 6F SR5.0 W/SH LAUN CATHETER LA6SR50SH LA 6F 100CM SR50 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-0968-06 · Apr 5, 2006 · Terminated
  CATH. GUIDE 6F SR6.0 W/SH LAUN Coronary Guiding catheter designed to provide a pathway through which therapeutic and/or diagnostic devices are introduced into the coronary or peri
• Z-0961-06 · Apr 5, 2006 · Terminated
  CATHETER LA6SR40A 6F 110CM SR4 CATHETER LA6SR40A 6F 110CM SR40 Coronary Guiding catheter designed to provide a pathway through which therapeutic and/or diagnostic devices are intr
• 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-0962-06 · Apr 5, 2006 · Terminated
  CATH. GUIDE 6F SR4.0 W/SH LAUN CATHETER LA6SR40SH LA 6F 100CM SR40 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

…and 37 more.