Launcher LA6JR35 (UDI 00613994817723)Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00613994817723), received between Aug 11, 2017 and Oct 28, 2021 — classified as 1 injury, 3 malfunctions.

The most frequently reported specific device problem is “Component or Accessory Incompatibility” (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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 28, 2021Use of Device Problem; Use of Device Problem

  IT WAS REPORTED THAT ONE 6F LAUNCHER GUIDE CATHETER WAS EXPIRED. NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12710656 ↗
• MalfunctionApr 8, 2021Material Deformation; Material Deformation

  DURING A PROCEDURE, AN ATTEMPT WAS MADE TO USE ONE 6 FRENCH LAUNCHER GUIDE CATHETER TO TREAT A LESION. THERE WAS NO DAMAGE NOTED TO THE PACKAGING. THE DEVICE WAS REMOVED FROM PACKAGING PER IFU WITH NO ISSUES NOTED. EXCESSIVE FORCE WAS NOT USED DURING INSERTION/DELIVERY. IT WAS REPORTED THAT THE CATHETER KINKED WHILE IN THE PATIENT. THE DEVICE WAS NOT EXCESSIVELY TORQUED OR EXCESSIVE FORCE WAS NOT USED. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11633365 ↗
• InjuryJan 31, 2018Component or Accessory Incompatibility; Material Distortion; Component or Accessory Incompatibility; Material Distortion

  THE PHYSICIAN INTENDED TO USE A 6F LAUNCHER GUIDE CATHETER. THERE WAS NO DAMAGE NOTED TO THE DEVICE PACKAGING. THE DEVICE WAS REMOVED FROM THE PACKAGING PER IFU. THE DEVICE WAS INSPECTED WITH NO ISSUES. THE DEVICE WAS PREPPED PER IFU WITH NO ISSUES. THE DEVICE WAS NOT EXCESSIVELY TORQUED. THE PROXIMAL RIGHT RADIAL ARTERY WAS THE ACCESS SITE. THE ARTERY WAS NON-TORTUOUS AND NON-CALCIFIED. NO RESISTANCE WAS NOTED WHEN INSERTING THE INTRODUCER. RESISTANCE WAS EXPERIENCED WHEN INSERTING THE CATHETER THROUGH THE 6F NON-MDT INTRODUCER, WITH ANOTHER DEVICE INSERTED THROUGH THE LUMEN OF THE GUIDE CATHETER. THE CATHETER WAS USED ON A TEFLON GUIDEWIRE AND A UNIDIRECTIONAL VALVE. IT IS REPORTED THAT AT THE MOMENT OF THE TRANSITION FROM THE INTRODUCER TO THE CATHETER THE PHYSICIAN FELT RESISTANCE OF THE PROXIMAL RADIAL ARTERY. EXCESSIVE FORCE WAS NOT USED DURING DELIVERY. THE PHYSICIAN TRIED ONCE TO ROTATE THE LAUNCHER DEVICE TO SEE IF IT WOULD MOVE BETTER, BUT IT DID NOT WORK AND DISSECTION OF THE PROXIMAL THIRD OF THE FOREARM OCCURRED. THE CATHETER WAS REMOVED AND IT WAS NOTED THAT THE TIP WAS DEFORMED- THE TIP WAS IRREGULAR. NO PORTION OF THE CATHETER WAS DETACHED. TO TREAT THE DISSECTION,

  Patient problems: Patient Problem/Medical Problem; Vascular Dissection

  MAUDE report 7232309 ↗
• MalfunctionAug 11, 2017Device Expiration Issue; Device Expiration Issue

  THE LAUNCHER GUIDE CATHETER WAS USED APPROX 5 DAYS PAST ITS EXPIRY DATE. PATIENT IS WELL. DEVICE DISCARDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6787898 ↗

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-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-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-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-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-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
• Z-0964-06 · Apr 5, 2006 · Terminated
  CATH. GUIDE 6F SR4.5 W/SH LAUN CATHETER LA6SR45SH LA 6F 100CM SR45 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-0996-06 · Apr 5, 2006 · Terminated
  CATHETER SA63DRC SA 6F 100CM 3 CATHETER SA63DRC SA 6F 100CM 3DRC Coronary Guiding catheter designed to provide a pathway through which therapeutic and/or diagnostic devices are in
• 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-0951-06 · Apr 5, 2006 · Terminated
  CATH. GUIDE 6F JL5.0 110CM LAU CATHETER LA6JL50A LA 6F 110CM JL50 Coronary Guiding catheter designed to provide a pathway through which therapeutic and/or diagnostic devices are i
• 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

…and 37 more.