Launcher LA5JR35Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00763000407308), received between Mar 10, 2023 and Mar 10, 2023 — classified as 1 malfunction.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (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.

• MalfunctionMar 10, 2023Entrapment of Device; Device Dislodged or Dislocated; Entrapment of Device; Device Dislodged or Dislocated

  AN ATTEMPT WAS MADE TO USE ONE RESOLUTE ONYX CORONARY DRUG-ELUTING STENT TO TREAT A MODERATELY TORTUOUS, MODERATELY CALCIFIED LESION WITH 75% STENOSIS IN THE MID CIRCUMFLEX (CX) ARTERY. THE DEVICE WAS INSPECTED WITH NO ISSUES NOTED. NEGATIVE PREP WAS PERFORMED WITH NO ISSUES NOTED. THE LESION WAS PREDILATED. THE DEVICE DID NOT PASS THROUGH A PREVIOUSLY DEPLOYED STENT OR CELL OF A STENT. RESISTANCE WAS NOT NOTED WHEN ADVANCING THE DEVICE. DURING THE PROCEDURE A MEDTRONIC GUIDE CATHETER WAS ALSO USED. THE GUIDE CATHETER WAS EXAMINED BEFORE USE WITH NO ISSUES NOTED. THERE WERE NO DIFFICULTIES NOTED WHEN LOADING THE STENT ONTO THE GUIDE CATHETER. IT WAS REPORTED THAT STENT DISLODGEMENT OCCURRED DURING DELIVERY TO THE LESION. IT WAS STATED THAT THE STENT GOT CAUGHT IN THE GUIDE CATHETER. THE DISLODGED STENT STAYED INSIDE THE CATHETER AND DID NOT REACH THE LESION. THE DISLODGED STENT WAS RECOVERED FROM THE PATIENT BY REMOVING THE CATHETER. NO RESISTANCE WAS NOTED DURING THE WITHDRAWAL OF THE DEVICE. THE GUIDE CATHETER WAS USED SUCCESSFULLY WITH OTHER DEVICES PRIOR TO THE DIFFICULTIES OCCURRING. THE PATIENT WAS REPORTED TO BE ALIVE WITH NO INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16519981 ↗

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