Launcher LA6IMARecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00613994821089), received between Aug 23, 2019 and Aug 23, 2019 — 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.

• MalfunctionAug 23, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  A LA6IMA LAUNCHER GUIDE CATHETER WAS ATTEMPTED TO BE USED. THERE WAS NO DAMAGE NOTED TO THE DEVICE PACKAGING. IT IS REPORTED THAT THE CATHETER TIP COMPLETELY DETACHED WHEN INSERTING IT INTO THE 6F NON-MDT SHEATH. THE TIP OF A SECOND CATHETER WAS THEN CHECKED AND WHEN GENTLY PRESSED THE TIP COMPLETELY DETACHED FROM THE CATHETER. NO PATIENT INJURY IS REPORTED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED USING ANOTHER LAUNCHER OF THE SAME SIZE. AT THE FACILITY THE CATHETERS ARE STORED IN THE NURSE'S ROOM IN A CLOSED CABINET, HANGING WITH RESTRICTED ACCESS. THERE IS A WINDOW IN THE ROOM BUT THE CATHETERS ARE NOT EXPOSED TO LIGHT SINCE THE CABINET IS CLOSED WITH WOODEN DOORS. THE CATHETERS ARE REMOVED FROM THE BOXES AND LEFT HANGING. THE ROOM TEMPERATURE IS APPROXIMATELY 20 DEGREES. ALTHOUGH IT WAS REPORTED THAT THE DEVICES WERE NOT USED IN THE PATIENT THE DAMAGE OBSERVED INDICATES THAT AN ATTEMPT MAY HAVE BEEN MADE TO INSERT THE DEVICES INTO THE INTRODUCER.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8925864 ↗
• MalfunctionAug 23, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  A LA6IMA LAUNCHER GUIDE CATHETER WAS ATTEMPTED TO BE USED. THERE WAS NO DAMAGE NOTED TO THE DEVICE PACKAGING. IT IS REPORTED THAT THE CATHETER TIP COMPLETELY DETACHED WHEN INSERTING IT INTO THE 6F NON-MDT SHEATH. THE TIP OF A SECOND CATHETER WAS THEN CHECKED AND WHEN GENTLY PRESSED THE TIP COMPLETELY DETACHED FROM THE CATHETER. NO PATIENT INJURY IS REPORTED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED USING ANOTHER LAUNCHER OF THE SAME SIZE. AT THE FACILITY THE CATHETERS ARE STORED IN THE NURSE'S ROOM IN A CLOSED CABINET, HANGING WITH RESTRICTED ACCESS. THERE IS A WINDOW IN THE ROOM BUT THE CATHETERS ARE NOT EXPOSED TO LIGHT SINCE THE CABINET IS CLOSED WITH WOODEN DOORS. THE CATHETERS ARE REMOVED FROM THE BOXES AND LEFT HANGING. THE ROOM TEMPERATURE IS APPROXIMATELY 20 DEGREES. ALTHOUGH IT WAS REPORTED THAT THE DEVICES WERE NOT USED IN THE PATIENT THE DAMAGE OBSERVED INDICATES THAT AN ATTEMPT MAY HAVE BEEN MADE TO INSERT THE DEVICES INTO THE INTRODUCER.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8925700 ↗

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-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-1247-2021 · Jan 15, 2021 · Terminated
  Medtronic 6F Launcher Guide Catheter 100cm EBU 3.75 Model Number: LA6EBU375
• 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-1000-06 · Apr 5, 2006 · Terminated
  CATHETER SA6SR50 SA 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-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-1006-06 · Apr 5, 2006 · Terminated
  CATHETER SB6SR40 SB 6F 100CM S CATHETER SB6SR40 SB 6F 100CM SR40 Coronary Guiding catheter designed to provide a pathway through which therapeutic and/or diagnostic devices are in
• 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-0952-06 · Apr 5, 2006 · Terminated
  CATH. GUIDE 6F JR4.0 110CM LAU CATHETER LA6JR40A LA 6F 110CM JR40 Coronary Guiding catheter designed to provide a pathway through which therapeutic and/or diagnostic devices are i
• 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-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-0957-06 · Apr 5, 2006 · Terminated
  CATH. GUIDE 6F SR3.0 W/SH LAUN CATHETER LA6SR30SH LA 6F 100CM SR30 Coronary Guiding catheter designed to provide a pathway through which therapeutic and/or diagnostic devices are

…and 37 more.