Launcher LA5ALR12Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00613994783769), received between Oct 11, 2019 and Oct 11, 2019 — classified as 1 injury.

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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryOct 11, 2019Difficult to Remove; Deformation Due to Compressive Stress; Material Deformation; Difficult to Remove; Deformation Due to Compressive Stress; Material Deformation

  A LAUNCHER GUIDE CATHETER WAS USED DURING A PROCEDURE. THERE WAS NO DAMAGE NOTED TO THE DEVICE PACKAGING. THE DEVICE WAS PLACED AND CONTRAST MEDIUM INJECTED. IT WAS DECIDED TO REMOVE THE DEVICE AS PRESSURE WAS UNABLE TO BE ACHIEVED. IT WAS REPORTED THAT THE DEVICE KINKED WHILE IN THE PATIENT AND COULD NOT BE REMOVED. THE PATIENT WAS SENT FOR SURGERY TO REMOVE THE DEVICE. PATIENT STATUS IS UNKNOWN AT THIS TIME.

  Patient problems: Injury

  MAUDE report 9178346 ↗

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