Launcher™ LA6AL20Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00763000897987), received between Feb 13, 2026 and Feb 13, 2026 — classified as 1 malfunction.

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

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.

• MalfunctionFeb 13, 2026Difficult to Insert; Difficult to Remove; Deformation Due to Compressive Stress; Material Deformation

  IT WAS REPORTED THAT DURING A PROCEDURE INVOLVING ONE 6F LAUNCHER GUIDE CATHETER, A KINK OCCURRED WHILE IN THE PATIENT APPROXIMATELY 12 INCHES FROM THE HUB AND REMOVAL DIFFICULTIES WERE ENCOUNTERED. THE LESION BEING TREATED WAS MODERATELY TORTUOUS, MILDLY CALCIFIED WITH 90% STENOSIS IN THE MID RIGHT CORONARY ARTERY (RCA). THE DEVICE WAS INSPECTED PRIOR TO USE WITH NO ISSUES NOTED. THE DEVICE WAS PREPPED PER IFU WITH NO ISSUES NOTED. RESISTANCE WAS NOT ENCOUNTERED WHEN ADVANCING THE DEVICE AND EXCESSIVE FORCE WAS NOT USED DURING INSERTION/DELIVERY. NO EXCESSIVE FORCE WAS USED AND THE DEVICE WAS NOT EXCESSIVELY TORQUED. IT WAS NOTED TO BE DIFFICULT TO PASS THE WIRE THROUGH THE LAUNCHER GUIDE CATHETER AND A KINK WAS NOTED ON THE X-RAY. IT WAS REPORTED TO BE DIFFICULT TO REMOVE THE LAUNCHER GUIDE CATHETER FOR APPROXIMATELY 5 MINUTES. IT WAS EVENTUALLY POSSIBLE TO ADVANCE THE SHEATH OVER THE KINK TO REMOVE THE CATHETER FROM THE BODY. THERE WAS NO HARM TO THE PATIENT AND IT WAS POSSIBLE TO RESUME THE CASE WITH ANOTHER LAUNCHER GUIDE CATHETER OF THE SAME MODEL. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24332256 ↗