Launcher LA6AR10Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00613994820433), received between Nov 26, 2018 and Jan 31, 2023 — classified as 1 injury, 2 malfunctions.

The most frequently reported specific device problem is “Material Deformation” (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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 31, 2023Material Deformation; Material Deformation

  AN ATTEMPT WAS MADE TO USE TWO RESOLUTE INTEGRITY RX CORONARY DRUG ELUTING STENTS AND ONE 6F LAUNCHER GUIDE CATHETER TO TREAT A MODERATELY TORTUOUS, SEVERELY CALCIFIED LESION WITH 70-80% STENOSIS, IN THE PROXIMAL RIGHT CORONARY ARTERY (RCA). A FEMORAL APPROACH WAS USED. ALL DEVICES WERE INSPECTED WITH NO ISSUES. NEGATIVE PREP WAS PERFORMED ON BOTH RESOLUTE INTEGRITY STENTS WITH NO ISSUES. THE LAUNCHER DEVICE WAS PREPPED PER IFU WITH NO ISSUES. THE LESION WAS PRE-DILATED. THE DEVICES DID NOT PASS THROUGH A PREVIOUSLY-DEPLOYED STENT. RESISTANCE WAS ENCOUNTERED WHEN ADVANCING THE LAUNCHER DEVICE AND THE FIRST RESOLUTE INTEGRITY STENT (RSINT35012X- PLI10). RESISTANCE WAS NOT ENCOUNTERED WHEN ADVANCING THE SECOND RESOLUTE INTEGRITY STENT (RSINT40012X- PL20). EXCESSIVE FORCE WAS NOT USED DURING DELIVERY OF ANY OF THE DEVICES. IT WAS REPORTED THAT STENT DEFORMATION OCCURRED IN VIVO DURING POSITIONING/ADVANCEMENT FOR BOTH STENTS. IT WAS LATER CONFIRMED THAT THE RSINT40012X STENT HAD NOT BEEN ABLE TO PASS THROUGH DUE TO THE LESION AND THE DECISIONWAS MADE TO CHANGE THE STENT BUT ISSUES OCCURRED DURING THE WITHDRAWAL. DIFFICULTIES WERE NOTED WHEN REMOVING THE RSINT40012X FROM THE PATIENT AND

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16271393 ↗
• MalfunctionJun 17, 2021Material Deformation; Material Deformation

  DURING A PROCEDURE, AN ATTEMPT WAS MADE TO USE ONE 6 FRENCH LAUNCHER GUIDE CATHETER TO TREAT A LESION. A FEMORAL PROCEDURAL APPROACH WAS USED. THERE WAS NO DAMAGE EVIDENT TO THE PROTECTIVE PACKAGING OF THE DEVICE. THERE WAS NO RESISTANCE NOTED WHILE REMOVING THE DEVICE FROM PACKAGING. THE DEVICE WAS INSPECTED AFTER REMOVAL FROM PACKAGING. THE DEVICE WAS NOT EXCESSIVELY TORQUED. THERE WAS NO RESISTANCE NOTED DURING THE INSERTION/DELIVERY OF THE DEVICE. IT WAS REPORTED THAT MULTIPLE KINKS IN PROXIMAL, MID AND DISTAL PORTIONS OF THE GUIDE OCCURRED WHILE IN THE PATIENT. IT WAS STATED THAT THE KINKS WERE OBSERVED AS THE TIP WAS BEING ADVANCED INTO THE SHEATH. THE GUIDE CATHETER WAS REMOVED IMMEDIATELY FROM THE BODY. IT WAS STATED THAT THE GUIDE WAS NOT ADVANCED PAST THE AORTIC ARCH. THE PATIENT WAS REPORTED TO BE ALIVE WITH NO INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12015069 ↗
• InjuryNov 26, 2018Detachment of Device or Device Component; Detachment of Device or Device Component

  A LAUNCHER DEVICE WAS INTENDED TO BE USED TO TREAT A LESION IN THE RCA. NO DAMAGE NOTED TO PACKAGING. THE DEVICE WAS REMOVED FROM THE PACKAGING AS PER IFU. THE DEVICE WAS INSPECTED WITH NO ISSUES NOTED. THE DEVICE WAS PREPPED AS PER IFU. THE PATIENT HAD AN UNUSUAL DEPARTURE OF THE CORONARY ARTERY FROM THE AORTA WHICH CAUSED THE GUIDE CATHETER TO BECOME TWISTED DURING INTUBATION. DURING USE, THE CATHETER WAS PARTIALLY TORN IN THE RIGHT ILIAC ARTERTY. THE ATTEMPT TO REMOVE THE CATHETER PART WAS MADE DURING ANOTHER SURGERY, USING FIBEROSCOPES PLIERS.THE ISSUE WAS CONSIDERED TO BE RELATED TO THE PATIENT ANATOMY AND NOT TO THE PRODUCT ITSELF. NO FURTHER PATIENT INJURY REPORTED.

  Patient problems: Patient Problem/Medical Problem

  MAUDE report 8101559 ↗

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-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
• Z-0999-06 · Apr 5, 2006 · Terminated
  CATHETER SA6SR40 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-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-0997-06 · Apr 5, 2006 · Terminated
  CATHETER SA63DRCSH Coronary Guiding catheter designed to provide a pathway through which therapeutic and/or diagnostic devices are introduced into the coronary or peripheral vascu
• 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-0944-06 · Apr 5, 2006 · Terminated
  CATH GUIDE 6F LAUNCHER EBU 4.5 CATHETER LA6EBU45A LA 6F 110CM EB45 Coronary Guiding catheter designed to provide a pathway through which therapeutic and/or diagnostic devices are
• 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-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.