Launcher LA6AR20SHRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00613994819772), received between May 15, 2019 and May 15, 2019 — classified as 1 malfunction.

The most frequently reported specific device problem is “Material Deformation” (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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 15, 2019Material Deformation; Material Deformation

  THE PHYSICIAN WAS USING A RESOLUTE INTEGRITY DEVICE AND A LAUNCHER GUIDE CATHETER TO TREAT A LESION IN THE MID RIGHT CORONARY ARTERY (RCA). THE LESION WAS MODERATELY TORTUOUS AND MODERATELY CALCIFIED WITH 80% STENOSIS. THERE WERE NO ABNORMALITIES REPORTED IN RELATION TO THE PATIENT¿S ANATOMY. NO ISSUES WERE NOTED TO THE DEVICE¿S PACKAGING, NO ISSUES WERE NOTED WHEN REMOVING THE RESOLUTE INTEGRITY FROM THE HOOP/TRAY. THE RESOLUTE INTEGRITY DEVICE WAS INSPECTED WITH NO ISSUES. THE LAUNCHER DEVICE WAS NOT INSPECTED. THE LAUNCHER DEVICE WAS REMOVED FROM THE PACKAGING AND PREPPED PER THE IFU. NEGATIVE PREP WAS PERFORMED ON THE RESOLUTE INTEGRITY DEVICE WITH NO ISSUES NOTED. THE LESION WAS PRE-DILATED, THE DEVICE DID NOT PASS THROUGH A PREVIOUSLY DEPLOYED STENT. RESISTANCE WAS NOT ENCOUNTERED HOWEVER EXCESSIVE FORCE WAS USED. IT WAS STATED THAT THE LAUNCHER WAS EXCESSIVELY TORQUED. IT WAS REPORTED THAT THE LAUNCHER BECAME TWISTED WHEN TURNING THE RIGHT SUBCLAVIAN ARTERY AND AS THE RESOLUTE INTEGRITY DEVICE WAS INSIDE THE LAUNCHER IT ALSO BECAME DEFORMED/TWISTED AT THE CATHETER/DELIVERY SYSTEM. IT WAS REPORTED THAT THE PHYSICIAN THINKS THAT THE EVENT WAS DUE TO THE USE OF THE DEVICE¿S IN

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8611670 ↗

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-1247-2021 · Jan 15, 2021 · Terminated
  Medtronic 6F Launcher Guide Catheter 100cm EBU 3.75 Model Number: LA6EBU375
• Z-1248-2021 · Jan 15, 2021 · Terminated
  Medtronic 6F Launcher Guide Catheter 100 cm EBU 3.0 Model Number: LA6EBU30
• 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-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-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-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-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-1005-06 · Apr 5, 2006 · Terminated
  CATHETER SB6SR35SH 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-0956-06 · Apr 5, 2006 · Terminated
  CATH. GUIDE 6F SR3.0 LAUNCHER CATHETER LA6SR30 LA 6F 100CM SR30 Coronary Guiding catheter designed to provide a pathway through which therapeutic and/or diagnostic devices are int
• Z-0942-06 · Apr 5, 2006 · Terminated
  CATH. GUIDE 6F EBU3.5 110CM LA CATHETER LA6EBU35A LA 6F 110CM EB35 Coronary Guiding catheter designed to provide a pathway through which therapeutic and/or diagnostic devices are
• 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-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

…and 37 more.