Launcher LA6EBU35 (UDI 00763000389451)Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 00763000389451), received between Mar 24, 2022 and Feb 1, 2023 — classified as 7 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Material Deformation” (3 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 18, 2026.

Most reported problems

Recent adverse event reports

The 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 1, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING THE INDEX PROCEDURE TWO LAUNCHER GUIDE CATHETERS WERE USED. DURING THE PROCEDURE A DISSECTION OCCURRED. IT WAS STATED THAT A MEDTRONIC LAUNCHER DEVICE WAS THE CAUSE OF THE DISSECTION.

  Patient problems: Vascular Dissection

  MAUDE report 16276224 ↗
• InjuryDec 22, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A PATIENT WAS ADMITTED TO HOSPITAL AND CORONARY ANGIOGRAPHY, OPTICAL COHERENCE TOMOGRAPHY (OCT) EXAMINATION AND DRUG BALLOON DILATATION WERE PLANNED TO BE PERFORMED. AN ATTEMPT WAS MADE TO USE ONE LAUNCHER GUIDE CATHETER DURING THE PROCEDURE AT THE LEFT CORONARY OSTIUM. THE REAL PRESSURE IN THE LUMEN COULD NOT BE MONITORED AND THE CATHETER WAS WITHDRAWN. IT WAS REPORTED THAT THE CATHETER WAS FLUSHED OUT WITH NORMAL SALINE AND A LARGE AMOUNT OF THROMBUS CAME OUT OF THE LAUNCHER. IT WAS STATED THAT IF IT HAD NOT BEEN DETECTED ON TIME THE EVENT COULD HAVE LEAD TO BLOOD CLOTS AND INFARCTION IN THE PATIENT. A REPLACEMENT 6F EBU CATHETER WAS USED TO CONTINUE THE TREATMENT AT THE LEFT CORONARY OSTIUM. NO FURTHER INJURY WAS REPORTED.

  Patient problems: Thrombosis/Thrombus

  MAUDE report 16032687 ↗
• InjuryDec 13, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A PATIENT PRESENTED AT THE HOSPITAL DUE TO THROAT PAIN, DISCOMFORT AND SHORTNESS OF BREATH. THE PATIENT WAS DIAGNOSED WITH ACUTE ST-SEGMENT ELEVATION LATERAL WALL MYOCARDIAL INFRACTION. AN EMERGENCY CORONARY ANGIOGRAM (CAG) AND A PERCUTANEOUS CORONARY INTERVENTION (PCI) PROCEDURE WAS PERFORMED. IT WAS REPORTED THAT DURING THE PROCEDURE WHEN A 6F LAUNCHER GUIDE CATHETER WAS REPLACED AND SENT TO THE RIGHT BRACHIAL ARTERY, THE TIP OF THE GUIDE CATHETER ACCIDENTALLY EXPOSED THE TIP OF THE ULTRA SMOOTH, NON MEDTRONIC GUIDEWIRE. THIS RESULTED IN A D-TYPE DISSECTION OF THE RIGHT BRACHIAL ARTERY. IT WAS STATED THAT INTRAOPERATIVE GUIDING CATHETER OPERATION WAS NOT STANDARDIZED, AND THE ULTRA-SMOOTH GUIDE WIRE DID NOT EXPOSE THE TIP OF THE GUIDING CATHETER, RESULTING IN THE BRACHIAL ARTERY INTIMA INJURY AND DISSECTION. THE NON MEDTRONIC GUIDEWIRE WAS TAKEN IMMEDIATELY TO FIND THE TRUE LUMEN THROUGH THE DISSECTION SEGMENT. A 2.0X16MM PRE-EXPANDED BALLOON WAS USED TO INFLATE THE DISSECTION SEGMENT USING A PRESSURE OF 12 ATM FOLLOWED BY A GUIDING CATHETER TO COMPLETE THE IMPLANTATION OF THE LEFT CIRCUMFLEX (LCX) STENT. THE BLOOD FLOW WAS RESTORED AFTER THE BALLOON WAS INFLATED.

  Patient problems: Insufficient Information; Vascular Dissection

  MAUDE report 15968569 ↗
• InjuryJul 28, 2022Material Too Rigid or Stiff; Defective Component; Material Deformation; Material Too Rigid or Stiff; Defective Component; Material Deformation

  DURING A PROCEDURE, AN ATTEMPT WAS MADE TO USE ONE 6F LAUNCHER GUIDE CATHETER TO TREAT A NON TORTUOUS, NON CALCIFIED LESION WITH 0% STENOSIS LOCATED IN THE MID RADIAL ARTERY. THERE WAS NO DAMAGE NOTED TO THE PACKAGING. THE DEVICE WAS REMOVED FROM PACKAGING AND PREPPED PER IFU WITH NO ISSUES NOTED. THE DEVICE WAS INSPECTED WITH ISSUES NOTED. RESISTANCE WAS NOT ENCOUNTERED WHEN ADVANCING THE DEVICE AND EXCESSIVE FORCE WAS NOT USED DURING INSERTION/DELIVERY. IT WAS REPORTED THAT THE LAUNCHER CATHETER FELT STIFFER AND LARGER THAN A 6F AND THAT THE TIP OF THE CATHETER FELT LIKE A RAZOR BLADE. IT WAS ALSO REPORTED THAT A DISSECTION OF THE RIGHT RADIAL OCCURRED BEFORE THE ELBOW. NO FURTHER PATIENT INJURY WAS REPORTED.

  Patient problems: Vascular Dissection

  MAUDE report 15121085 ↗
• InjuryJul 28, 2022Material Too Rigid or Stiff; Defective Component; Material Too Rigid or Stiff; Defective Component

  DURING A PROCEDURE, AN ATTEMPT WAS MADE TO USE ONE 6F LAUNCHER GUIDE CATHETER TO TREAT A NON TORTUOUS, NON CALCIFIED LESION WITH 0% STENOSIS LOCATED IN THE MID RADIAL ARTERY. THERE WAS NO DAMAGE NOTED TO THE PACKAGING. THE DEVICE WAS REMOVED FROM PACKAGING AND PREPPED PER IFU WITH NO ISSUES NOTED. THE DEVICE WAS INSPECTED WITH NO ISSUES NOTED. RESISTANCE WAS NOT ENCOUNTERED WHEN ADVANCING THE DEVICE AND EXCESSIVE FORCE WAS NOT USED DURING INSERTION/DELIVERY. IT WAS REPORTED THAT THE CATHETER SEEMED STIFFER, RIGID AND LARGER THAN THE A 6F CATHETER AND THAT THE TIP OF THE CATHETER FELT LIKE A RAZOR BLADE. IT WAS ALSO REPORTED THAT A DISSECTION OF THE RIGHT RADIAL ARTERY OCCURRED BEFORE THE ELBOW. NO FURTHER PATIENT INJURY WAS REPORTED.

  Patient problems: Vascular Dissection

  MAUDE report 15121039 ↗
• InjuryJun 30, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING THE INDEX PROCEDURE ONE LAUNCHER GUIDE CATHETER, FOUR EUPHORA AND NC EUPHORA BALLOONS, AND TWO RESOLUTE ONYX DRUG ELUTING STENTS WERE USED TO TREAT A LESION IN THE LAD. DURING THE PROCEDURE A PERFORATION/DISSECTION OCCURRED. THE SITE DENIES ANY DEVICE MALFUNCTION OF BALLOONS OR STENTS.

  Patient problems: Perforation; Vascular Dissection

  MAUDE report 14869701 ↗
• MalfunctionMar 29, 2022Material Deformation; Material Deformation

  ONE 6F TELESCOPE GUIDE EXTENSION CATHETER (GEC) (PLI10), TWO EUPHORA RX BALLOON CATHETERS (EUP22512X - PLI20, EUP3015X - PLI30), ONE RESOLUTE ONYX CORONARY DRUG ELUTING STENT (DES) (RONYX2.5X34 - PLI40) AND ONE LAUNCHER GUIDE CATHETER (LA6EBU35 - PLI50) WERE ATTEMPTED TO BE USED TO TREAT A SEVERELY CALCIFIED, MODERATELY TORTUOUS PROXIMAL - MID LEFT ANTERIOR DESCENDING (LAD) ARTERY - DIAGONAL BRANCH - CIRCUMFLEX (CX) ARTERY. THE PROXIMAL - MID LAD HAD 80% STENOSIS INVOLVING A LARGE 1ST DIAGONAL (D1); THE PROXIMAL LCX AND THE OBTUSE MARGINAL (OM2) HAD 80% STENOSIS AND THERE WERE IRREGULARITIES IN THE RIGHT CORONARY ARTERY (RCA). ABNORMALITIES WERE REPORTED IN RELATION TO ANATOMY. THERE WAS NO DAMAGE NOTED TO ANY OF THE DEVICES PACKAGING. THE DEVICES WERE REMOVED FROM THE PACKAGING PER IFU WITH NO ISSUES NOTED. THE DEVICES WERE INSPECTED AND PREPPED PER IFU WITH NO ISSUES NOTED. RESISTANCE WAS NOT ENCOUNTERED WHEN ADVANCING THE TELESCOPE DEVICE AND EXCESSIVE FORCE WAS NOT USED DURING DELIVERY, HOWEVER RESISTANCE WAS EXPERIENCED DURING USE WITH THE RESOLUTE ONYX, WHEN INSERTING THROUGH THE GEC LUMEN, AND THE DEVICES BECAME DAMAGED. THE TELESCOPE DEVICE WAS EXCESSIVELY TORQUED. RESISTAN

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13938802 ↗
• MalfunctionMar 28, 2022Detachment of Device or Device Component; Material Deformation; 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 NOTED TO THE PACKAGING. THE DEVICE WAS REMOVED FROM THE PACKAGING PER IFU WITH NO ISSUES NOTED. THE DEVICE WAS INSPECTED WITH NO ISSUES. THE DEVICE WAS PREPPED PER IFU WITH NO ISSUES NOTED. RESISTANCE WAS NOT ENCOUNTERED WHEN ADVANCING THE DEVICE. EXCESSIVE FORCE WAS NOT USED DURING INSERTION OR DELIVERY. IT WAS REPORTED THAT THE TIP OF THE CATHETER WAS NOTED TO BE BROKEN AFTER THE PROCEDURE WHILE REMOVING THE DEVICE. THE PATIENT IS ALIVE WITH NO INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13926323 ↗
• InjuryMar 24, 2022Device Damaged by Another Device; Device Damaged by Another Device

  ONE IN.PACT FALCON DRUG COATED BALLOON CATHETER WAS ATTEMPTED TO BE USED TO TREAT A LESION WITH 80% STENOSIS IN THE DISTAL LEFT ANTERIOR DESCENDING CORONARY ARTERY (LAD) AND DIAGONAL BRANCHES OF THE LEFT CORONARY ARTERY. THERE WAS NO DAMAGE NOTED TO THE DEVICE PACKAGING. THERE WERE NO ISSUES NOTED WHEN REMOVING THE DEVICE FROM THE HOOP. THERE WERE NO DIFFICULTIES TO REMOVE THE PROTECTIVE SHEATH OR PACKAGING STYLETTE. THE DEVICE WAS INSPECTED PRIOR TO USE WITH NO ISSUES NOTED. NEGATIVE PREP WAS PERFORMED WITH NO ISSUES NOTED. THE LESION WAS PRE-DILATED WITH 3.0 X 30MM AND 3.5 X 15MM BALLOONS AT 20 ATM. THE IN.PACT FALCON DEVICE DID NOT PASS THROUGH A PREVIOUSLY DEPLOYED STENT. RESISTANCE WAS ENCOUNTERED WHEN ADVANCING THE DEVICE. THERE WERE NO DIFFICULTIES NOTED DURING FIRST AND ONLY INFLATION PERFORMED AT 12 ATM. THE DEVICE WAS NOT MOVED OR RE-POSITIONED WHILE INFLATED. THE CONCENTRATION OF SALINE USED WAS 1:2 (50%). IT WAS REPORTED THAT AFTER THE BALLOON WAS INFLATED THE INNER CHANNEL WAS FOUND TO BE BLOCKED AND IT WAS NOT POSSIBLE TO DRAW THE CONTRAST FROM INSIDE THE BALLOON WHICH LED TO UNINTENDED LONG INFLATION TIME, WITH SYMPTOMS OF ISCHEMIA DEVELOPING IN THE PATIENT AND THE N

  Patient problems: Insufficient Information

  MAUDE report 13892609 ↗

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-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-1248-2021 · Jan 15, 2021 · Terminated
  Medtronic 6F Launcher Guide Catheter 100 cm EBU 3.0 Model Number: LA6EBU30
• 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-1008-06 · Apr 5, 2006 · Terminated
  CATHETER SB6SR50 SB 6F 100CM S Coronary Guiding catheter designed to provide a pathway through which therapeutic and/or diagnostic devices are introduced into the coronary or peri
• 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-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-0958-06 · Apr 5, 2006 · Terminated
  CATH. GUIDE 6F SR3.5 LAUNCHER CATHETER LA6SR35 LA 6F 100CM SR35 Coronary Guiding catheter designed to provide a pathway through which therapeutic and/or diagnostic devices are int
• Z-1019-06 · Apr 5, 2006 · Terminated
  CATH, GUIDE 6F JR4.0 SH 110CM Coronary Guiding catheter designed to provide a pathway through which therapeutic and/or diagnostic devices are introduced into the coronary or perip
• 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-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-0945-06 · Apr 5, 2006 · Terminated
  CATHETER LA6HSIA 6F 110CM HSI Coronary Guiding catheter designed to provide a pathway through which therapeutic and/or diagnostic devices are introduced into the coronary or perip
• Z-0948-06 · Apr 5, 2006 · Terminated
  CATH. GUIDE 6F JL4.0 110CM LAU CATHETER LA6JL40A LA 6F 110CM JL40 Coronary Guiding catheter designed to provide a pathway through which therapeutic and/or diagnostic devices are i

…and 37 more.