Launcher LA5JR40Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00613994782687), received between Oct 17, 2018 and Oct 21, 2019 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Deformation Due to Compressive Stress” (1 report).

1 other recall cover devices cleared under the same FDA submission (K103386); 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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 21, 2019Deformation Due to Compressive Stress; Material Deformation; Deformation Due to Compressive Stress; Material Deformation

  A LAUNCHER 5F GUIDE CATHETER WAS USED TO TREAT A MODERATELY TORTUOUS, MODERATELY CALCIFIED LESION IN THE RIGHT CORONARY ARTERY (RCA). THERE WAS NO DAMAGE NOTED TO PACKAGING. THE DEVICE WAS REMOVED FROM PACKAGING AS PER IFU WITH NO ISSUES. THE DEVICE WAS INSPECTED WITH NO ISSUES. THE DEVICE WAS PREPPED AS PER IFU WITH NO ISSUES. RESISTANCE WAS ENCOUNTERED WHEN ADVANCING THE DEVICE. EXCESSIVE FORCE WAS NOT USED DURING DELIVERY. THE DEVICE WAS NOT EXCESSIVELY TORQUED. IT WAS REPORTED THAT RESISTANCE WAS EXPERIENCE DURING DELIVERY TO THE TARGET LESION AND THE CATHETER BUCKLED IN THE MIDDLE OF THE CATHETER AS THEY TRIED TO ENGAGE. IT WAS ALSO REPORTED THAT AFTER SOME STRUGGLE THE CATHETER WAS EXTRACTED FROM THE SHEATH AND ONCE THE SHEATH WAS REMOVED HEMATOMA WAS NOTICED. NO INTERVENTION WAS REQUIRED TO REMOVE THE DEVICE FROM THE SHEATH.

  Patient problems: Hematoma

  MAUDE report 9212731 ↗
• MalfunctionOct 17, 2018Use of Device Problem; Use of Device Problem

  IT IS REPORTED THAT AN EXPIRED LAUNCHER DEVICE WAS USED DURING A PROCEDURE. NO PATIENT INJURY REPORTED. THE PRODUCTS WERE NOT EXPIRED WHEN THE DISTRIBUTOR SENT THE ITEM TO THE HOSPITAL. IT WAS CONFIRMED THAT THE DEVICE WAS EXPIRED BY THE USAGE REPORT PROVIDED BY THE MEDTRONIC REP AND CONFIRMED WITH THE CATH LAB. THE PROCESS FOR CONTROLLING SHORT DATED/EXPIRED PRODUCT AT THE ACCOUNT IS AGING MONITORING OF EXPIRATION DATES AND PULL-OUT OF THE NEAR EXPIRY ITEMS BEFORE 30 DAYS FROM THE EXPIRATION DATE. PRODUCTS ARE MANAGED BY THE HOSPITAL THROUGH CONSIGNMENT AND CURRENT PROCESS IS INVENTORY BEING MONITORED BY THE DISTRIBUTOR AND MEDTRONIC.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7973384 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K103386. One submission often covers many models, so check the product and lot details in each record.

• 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