Launcher LA6JR40 (UDI 00613994817778)Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 00613994817778), received between Jul 12, 2017 and Dec 4, 2019 — classified as 5 injuries, 5 malfunctions.

The most frequently reported specific device problem is “Material Deformation” (7 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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 4, 2019Material Deformation; Material Deformation

  A LAUNCHER 6F GUIDE CATHETER WAS USED TO TREAT A MILDLY TORTUOUS LESION WITH 99% STENOSIS IN THE MID RCA. THERE WAS NO DAMAGE NOTED TO THE DEVICE PACKAGING. THE DEVICE WAS REMOVED FROM THE PACKAGING AND PREPPED AS PER IFU. THE DEVICE WAS INSPECTED PRIOR TO USE. RESISTANCE WAS NOT ENCOUNTERED WHEN ADVANCING THE DEVICE AND EXCESSIVE FORCE WAS NOT USED DURING DELIVERY. THE DEVICE WAS NOT EXCESSIVELY TORQUED. IT WAS REPORTED THAT THE DISTAL END OF THE GUIDE CATHETER KINKED WHILE THE DEVICE WAS IN THE ILIAC, JUST PAST THE SHEATH. THE PATIENT IS ALIVE WITH NO INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9408540 ↗
• InjurySep 17, 2019Deformation Due to Compressive Stress; Detachment of Device or Device Component; Material Deformation; Deformation Due to Compressive Stress; Detachment of Device or Device Component; Material Deformation

  A 6FR LAUNCHER GUIDE CATHETER WAS USED DURING A PROCEDURE. IT WAS REPORTED THAT THE DEVICE WAS INSERTED INTO THE PATIENT'S BODY AND THE DEVICE KINKED ON TORQUING. WHEN ATTEMPTED TO BE REMOVED IT SHEARED OFF PRODUCT WAS RETRIEVED VIA SNARE. NO FURTHER PATIENT INJURY REPORTED.

  Patient problems: Injury

  MAUDE report 9074831 ↗
• MalfunctionSep 11, 2019Deformation Due to Compressive Stress; Material Deformation; Deformation Due to Compressive Stress; Material Deformation

  TWO LAUNCHER GUIDE CATHETERS WERE INTENDED TO BE USED DURING A PROCEDURE. NO DAMAGE WAS NOTED TO PACKAGING. THE DEVICE WAS REMOVED FROM THE PACKAGING AS PER IFU WITH ISSUES NOTED. IT WAS REPORTED THAT THE DEVICES WERE KINKED AT THE PROXIMAL END OF THE CATHETER PRIOR TO REMOVAL FROM THE PACKAGING. IT WAS LATER CONFIRMED THAT WHEN THE DEVICES WERE INTRODUCED INTO THE PATIENT THEY DID NOT FLOW NORMALLY AND WHEN REMOVED FROM THE PATIENT THEY WERE NOTED TO BE DAMAGED. NO PATIENT INJURY REPORTED.

  Patient problems: Increased Respiratory Rate; No Consequences Or Impact To Patient

  MAUDE report 8988043 ↗
• MalfunctionSep 11, 2019Deformation Due to Compressive Stress; Material Deformation; Deformation Due to Compressive Stress; Material Deformation

  TWO LAUNCHER GUIDE CATHETERS WERE INTENDED TO BE USED DURING A PROCEDURE. NO DAMAGE WAS NOTED TO PACKAGING. THE DEVICE WAS REMOVED FROM THE PACKAGING AS PER IFU WITH ISSUES NOTED. IT WAS REPORTED THAT THE DEVICES WERE KINKED AT THE PROXIMAL END OF THE CATHETER PRIOR TO REMOVAL FROM THE PACKAGING. IT WAS LATER CONFIRMED THAT WHEN THE DEVICES WERE INTRODUCED INTO THE PATIENT THEY DID NOT FLOW NORMALLY AND WHEN REMOVED FROM THE PATIENT THEY WERE NOTED TO BE DAMAGED. NO PATIENT INJURY REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8988004 ↗
• InjurySep 6, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING A PROCEDURE, A LAUNCHER GUIDE CATHETER WAS USED TO TREAT A MILDLY CALCIFIED, MODERATELY TORTUOUS MID DISTAL LESION EXHIBITING 85% STENOSIS AND A PROXIMAL LESION EXHIBITING 60% STENOSIS IN THE OSTIUM OF THE RIGHT CORONARY ARTERY (RCA). THE LESION WAS PRE-DILATED. IT WAS REPORTED THAT A DISSECTION OCCURRED FROM THE OSTIUM TO MID/DISTAL RCA. THE DISSECTION WAS CAUSED BY THE LAUNCHER GUIDE CATHETER. FOUR RESOLUTE ONYX RX CORONARY, DRUG ELUTING STENTS (RONYX22538X, RONYX35038X, RONYX35038X, RONYX35022X) WERE USED TO TREAT THE DISSECTION. THE DEVICES WERE INSPECTED WITH NO ISSUES. NEGATIVE PREP WAS PERFORMED WITH NO ISSUES. THE DEVICES DID PASS THROUGH A PREVIOUSLY DEPLOYED STENT. RESISTANCE WAS NOT ENCOUNTERED WHEN ADVANCING THE DEVICES AND EXCESSIVE FORCE WAS NOT USED DURING DELIVERY OF THE DEVICES. THE STENT BALLOON WAS USED TO PRE-DILATE THE OVERLAP OF STENTS. IT WAS REPORTED THAT IT WAS DIFFICULT TO REMOVE THE STENT DELIVERY SYSTEMS OF THE TWO 3.50X38 MM DEVICES FROM A NON-MEDTRONIC WIRE FOLLOWING POST-DILATION. THE SAME WIRE HAD BEEN USED THROUGHOUT THE CASE. IT WAS REPORTED THAT A GOOD RESULT WAS ACHIEVED FROM USING THE FOUR RESOLUTE ONYX STENTS TO TREAT THE DISSECTION.

  Patient problems: Vascular Dissection

  MAUDE report 8968626 ↗
• MalfunctionAug 19, 2019Material Puncture/Hole; Gas/Air Leak; Material Deformation

  A JR4 CATHETER WAS USED TO ENGAGED THE RIGHT CORONARY ARTERY FOR A STENT PLACEMENT. THE SITE WAS PREDILATE, STENTED AND POST DILATED WITHOUT COMPLICATION. DURING POST ANGIOGRAM OF THE RIGHT CORONARY ARTERY, BUBBLES WERE SENT DOWN THE VESSEL. ST ELEVATION WAS NOTED ON THE EKG. SLOW FLOW WAS NOTED IN THE VESSEL. INTRACORONARY NITROPRUSSIDE WAS ADMINISTERED. PATIENT WAS STARTED ON A LEVOPHED DRIP. ST ELEVATION RESOLVE WITH IC NIPRIDE. A KINK/HOLE WAS NOTED ON THE CATHETER BY THE PHYSICIAN. THE PHYSICIAN CONCLUDED THAT THE KINK/HOLE ON THE CATHETER COULD OF CAUSE THE BUBBLES. SPOKE WITH CARDIAC CATHETER LAB CLINICAL MANAGER. DURING CATHETERIZATION, THE PROCEDURALIST WAS ATTEMPTING TO MANIPULATE THE CATHETER GUIDE IN A NORMAL FASHION TO MAINTAIN ACCESS. DURING THIS MANIPULATION, THE LINE WAS THOUGHT TO HAVE BECOME KINKED WHICH LED TO THE ABOVE INCIDENT. AFTER NEEDED INTERVENTIONS, THE PATIENT HAD A FAVORABLE OUTCOME. PATIENT REMAINS IN HOUSE FOR OBSERVATION PURPOSES.

  Patient problems: Myocardial Infarction

  MAUDE report 8905820 ↗
• InjuryJul 30, 2019Leak/Splash; Deformation Due to Compressive Stress; Material Deformation; Leak/Splash; Deformation Due to Compressive Stress; Material Deformation

  A LAUNCHER DEVICE WAS ATTEMPTED TO BE USED DURING A PROCEDURE TO TREAT A SEVERELY TORTUOUS, SEVERELY CALCIFIED LESION EXHIBITING 70% STENOSIS IN THE OSTIUM OF THE RIGHT CORONARY ARTERY (RCA). THERE WAS NO DAMAGE NOTED TO THE PACKAGING. THE DEVICE WAS REMOVED FROM THE PACKAGING AS PER IFU WITH NO ISSUES. THE DEVICE WAS INSPECTED AND PREPPED AS PER IFU WITH NO ISSUES. IT WAS REPORTED THAT THE SUBCLAVIAN WAS EXTREMELY TORTUOUS AND CAUSED THE GUIDE CATHETER TO SEVERELY KINK AFTER POST DILATION. IT WAS ALSO REPORTED THAT THERE WAS A SMALL HOLE WHERE THE GUIDE KINKED WHICH CAUSED AN AIR EMBOLI. THE AIR EMBOLI RESULTED IN ST ELEVATION WITH SLOW FLOW, WHICH WAS THEN TREATED WITH NIPRIDE. NO FURTHER PATIENT INJURY WAS REPORTED.

  Patient problems: Air Embolism

  MAUDE report 8840203 ↗
• InjuryJan 9, 2018Component or Accessory Incompatibility; Material Distortion; Component or Accessory Incompatibility; Material Distortion

  THE PHYSICIAN INTENDED TO USE A LAUNCHER GUIDE CATHETER TO TREAT A SEVERELY TORTUOUS, MODERATELY CALCIFIED LESION WITH CHRONIC TOTAL OCCLUSION IN THE PROXIMAL RIGHT CORONARY ARTERY. THERE WAS NO DAMAGE NOTED TO THE DEVICE PACKAGING. THE DEVICE WAS REMOVED FROM THE PACKAGING PER IFU WITH NO ISSUES. THE DEVICE WAS INSPECTED WITH NO ISSUES. THE DEVICE WAS PREPPED PER IFU WITH NO ISSUES. THE DEVICE WAS NOT EXCESSIVELY TORQUED. RESISTANCE WAS NOT ENCOUNTERED WHEN ADVANCING THE DEVICE AND EXCESSIVE FORCE WAS NOT USED DURING INSERTION/DELIVERY. THE COMMON FEMORAL PRESENTED WITH TORTUOSITY AND CALCIUM. THE 6FR NON-MDT SHEATH ANGLE WAS VERY STEEP AND THE SHEATH WAS KINKED DURING THE PROCEDURE AND LOCKED ON TO THE GUIDE CATHETER. THE PHYSICIAN HAD TO REMOVE THE SHEATH AND THE LAUNCHER AT THE SAME TIME AS THEY WERE STUCK TOGETHER. THEN THE GUIDE CATHETER WAS STILL UP OVER THE ARCH. AT THAT TIME THE LAUNCHER WAS CUT (OUTSIDE THE PATIENT BODY) DISTAL TO THE REMOVED SHEATH THAT WAS LOCKED ONTO THE GUIDE CATHETER. A 0.035 NON-MDT WIRE WAS RE-INTRODUCED THROUGH THE CUT PORTION OF THE GUIDE CATHETER, ALONG WHERE THE CUT WAS MADE, TO SAFELY REMOVE IT FROM THE PATIENT. THE LUMEN WAS CRUSHED ON THE GU

  Patient problems: Patient Problem/Medical Problem

  MAUDE report 7174477 ↗
• MalfunctionOct 17, 2017Material Deformation; Material Deformation

  IT WAS REPORTED THAT THE PHYSICIAN USED A LAUNCHER LA6JR40 GUIDE CATHETER (GC) WHEN TREATING A LESION EXHIBITING MODERATE TORTUOSITY AND MODERATE CALCIFICATION, LOCATED IN THE OSTIUM OF THE RCA. THERE WERE NO ABNORMALITIES REPORTED IN RELATION TO ANATOMY. THERE WAS NO DAMAGE NOTED TO PACKAGING. THE DEVICE WAS REMOVED FROM PACKAGING, INSPECTED AND PREPPED AS PER THE IFU WITH NO ISSUES. RESISTANCE WAS ENCOUNTERED WHEN ADVANCING THE DEVICE. THE PHYSICIAN NOTED THAT THE RESISTANCE WAS DUE TO INTERACTION WITH ANOTHER DEVICE. EXCESSIVE FORCE WAS NOT USED DURING INSERTION/DELIVERY. IT WAS NOTED THAT DURING THE PCI PROCEDURE, THE PHYSICIAN OBSERVED THAT THE GUIDING CATHETER LOOKED ABNORMAL. THE DEVICE WAS REMOVED FROM THE PATIENT, AND THE STEEL WIRE BRAID OF THE DEVICE WAS FOUND FRACTURED. NO REPORT OF THE DEVICE BEING TORQUED AT ANY STAGE DURING THE PROCEDURE. THE PHYSICIAN REPLACED THE DEVICE WITH A NEW MDT CATHETER TO COMPLETE THE OPERATION. THERE IS NO PATIENT INJURY REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6954255 ↗
• InjuryJul 12, 2017Detachment of Device or Device Component; Detachment of Device or Device Component

  THE PHYSICIAN USED A LAUNCHER LA6JR40 GUIDE CATHETER WHEN TREATING A 90% STENOTIC LESION IN THE RCA. LESION ALSO EXHIBITED MODERATE CALCIFICATION AND MODERATE TORTUOSITY. NO DAMAGE WAS NOTED TO THE GUIDE CATHETER PACKAGING. THE DEVICE WAS REMOVED FROM PACKAGING AND PREPPED PER IFU WITH NO ISSUES. THE GUIDE CATHETER WAS NOT INSPECTED. THE DEVICE WAS INSERTED DURING AN ATTEMPT TO CANNULATE THE RCA. NO RESISTANCE WAS ENCOUNTERED WHEN ADVANCING THE DEVICE AND EXCESSIVE FORCE WAS NOT USED. A NON-MDT GUIDE WIRE WAS INSERTED AND ADVANCED TO THE END OF THE GUIDE CATHETER. WHILE POSITIONING THE GUIDE CATHETER IT KINKED AND POTENTIALLY FRACTURED. MULTIPLE BALLOONS WERE INSERTED AND INFLATED INSIDE THE KINKED AREA IN AN ATTEMPT TO RETRIEVE THE GUIDE CATHETER BUT WERE UNSUCCESSFUL. THE END OF THE CATHETER CAME LOOSE AND THE CATHETER BROKE APART. THE END OF THE CATHETER WAS REMOVED WHILE MAINTAINING WIRE PLACEMENT INTO THE ASCENDING AORTA. ANOTHER BALLOON WAS USED IN AN ATTEMPT TO RETRIEVE THE GUIDE CATHETER. THE BALLOON WAS REMOVED, AND A 0.025" WIRE WAS INSERTED AND ADVANCED INTO THE ASCENDING AORTA. THE 6FR LONG ARTERIAL SHEATH WAS REMOVED AND EXCHANGED WITH AN 8FR SHEATH. A GOOSENECK 10 MM

  Patient problems: Patient Problem/Medical Problem

  MAUDE report 6705262 ↗

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-1002-06 · Apr 5, 2006 · Terminated
  CATHETER SB63DRCSH 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-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-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-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-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-0938-06 · Apr 5, 2006 · Terminated
  CATH. GUIDE 6F 3DRC W/SH LAUNC CATHETER LA63DRCSH LA 6F 100CM 3DRC Coronary Guiding catheter designed to provide a pathway through which therapeutic and/or diagnostic devices are
• 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-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-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

…and 37 more.