Launcher LA7AL10Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00613994833877), received between Dec 11, 2018 and Sep 28, 2023 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Material Deformation” (3 reports).

13 other recalls cover devices cleared under the same FDA submission (K022764); 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 28, 2023Difficult to Remove; Material Deformation; Difficult to Remove; Material Deformation

  AN ATTEMPT WAS MADE TO USE ONE LAUNCHER 7F GUIDE CATHETER DURING A PROCEDURE. THE DEVICE WAS INSPECTED WITH NO ISSUES NOTED. THE DEVICE WAS PREPPED AS PER IFU WITH NO ISSUES NOTED. RESISTANCE WAS NOT ENCOUNTERED WHEN ADVANCING THE DEVICE. EXCESSIVE FORCE WAS NOT USED DURING THE DELIVERY. IT WAS REPORTED THAT A KINK OCCURRED WHILE THE GUIDE CATHETER WAS IN THE PATIENT. IT WAS DETAILED THAT THE CATHETER WAS INSERTED BY RADIAL ACCESS AND THE KINK OCCURRED AT THE FIRST TORSION. THE DEVICE DID NOT REACH THE AORTIC ARCH. THE GUIDE CATHETER WAS THEN REMOVED BUT WAS MET WITH MANY DIFFICULTIES. IT WAS NOTED THAT THE GUIDE CATHETER HAD LENGTHENED. EXCESSIVE FORCE WAS NOT USED. THE DEVICE WAS NOT EXCESSIVELY TORQUED. THE PATIENT IS ALIVE WITH NO INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17830916 ↗
• MalfunctionDec 18, 2020Detachment of Device or Device Component; Material Deformation; Detachment of Device or Device Component; Material Deformation

  A 7F LAUNCHER GUIDE CATHETER WAS USED DURING A PROCEDURE. IT WAS REPORTED THAT THE GUIDE CATHETER SEPARATED IN THE PROXIMAL PORTION OF THE CATHETER. THE DEVICE WAS INSPECTED BEFORE USE WITH NO ISSUES NOTED. RESISTANCE WAS NOT NOTED DURING DELIVERY. THE DEVICE WAS NOT KINKED AND RE-STRAIGHTENED DURING USE. BOTH PORTIONS OF THE GUIDE CATHETER WERE REMOVED FROM THE PATIENT WITH NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11036944 ↗
• MalfunctionJul 28, 2020Deformation Due to Compressive Stress; Material Deformation; Deformation Due to Compressive Stress; Material Deformation

  ONE LAUNCHER GUIDE CATHETER WAS ATTEMPTED TO BE USED. THERE WAS NO DAMAGE NOTED TO THE DEVICE PACKAGING. THE DEVICE WAS REMOVED FROM THE PACKAGING PER IFU WITH NO ISSUES. THE DEVICE WAS INSPECTED WITH NO ISSUES. THE DEVICE WAS PREPPED PER IFU WITH NO ISSUES. IT WAS REPORTED THAT THE CATHETER KINKED WHILE IN THE PATIENT. THE PATIENT WAS REPORTED TO BE ALIVE WITH NO INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10331041 ↗
• MalfunctionDec 11, 2018Use of Device Problem; Use of Device Problem

  A LAUNCHER CATHETER WAS USED TO TREAT A NON TORTUOUS, NON CALCIFIED LESION IN THE MID RCA. NO DAMAGE NOTED TO PACKAGING, NO ISSUES REMOVING DEVICE FROM PACKAGING AS PER IFU. THE DEVICE WAS INSPECTED WITH NO ISSUES NOTED. THE DEVICE WAS PREPPED WITH NO ISSUE NOTED, THE APPEARANCE OF THE DEVICE WAS FINE. IT IS REPORTED THAT THE DEVICE WAS USED DURING A ROUTINE INTERVENTION AFTER THE PRODUCT HAD EXPIRED. NO PATIENT INJURY REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8150533 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K022764. One submission often covers many models, so check the product and lot details in each record.

• Z-0979-06 · Apr 5, 2006 · Terminated
  CATH. GUIDE 7F SR4.0 W/SH LAUN CATHETER LA7SR40SH LA 7F 100CM SR40 Coronary Guiding catheter designed to provide a pathway through which therapeutic and/or diagnostic devices are
• Z-0971-06 · Apr 5, 2006 · Terminated
  CATHETER LA7MB1A LA 7F 110CM M CATHETER LA7MB1A LA 7F 110CM MB Coronary Guiding catheter designed to provide a pathway through which therapeutic and/or diagnostic devices are intr
• Z-0975-06 · Apr 5, 2006 · Terminated
  CATH. GUIDE 7F SR3.5 W/SH LAUN CATHETER LA7SR35SH LA 7F 100CM SR35 Coronary Guiding catheter designed to provide a pathway through which therapeutic and/or diagnostic devices are
• Z-1009-06 · Apr 5, 2006 · Terminated
  CATHETER SB73DRCSH SB 7F 100CM Coronary Guiding catheter designed to provide a pathway through which therapeutic and/or diagnostic devices are introduced into the coronary or peri
• Z-0969-06 · Apr 5, 2006 · Terminated
  CATH. GUIDE 7F 3DRCC LAUNCHER CATHETER LA73DRC LA 7F 100CM 3DRC Coronary Guiding catheter designed to provide a pathway through which therapeutic and/or diagnostic devices are int
• Z-0972-06 · Apr 5, 2006 · Terminated
  CATH. GUIDE 7F SR3.0 LAUNCHER CATHETER LA7SR30 LA 7F 100CM SR30 Coronary Guiding catheter designed to provide a pathway through which therapeutic and/or diagnostic devices are i
• Z-0978-06 · Apr 5, 2006 · Terminated
  CATH. GUIDE 7F SR4.0 LAUNCHER CATHETER LA7SR40 LA 7F 100CM SR40 Coronary Guiding catheter designed to provide a pathway through which therapeutic and/or diagnostic devices are int
• Z-0976-06 · Apr 5, 2006 · Terminated
  CATH. GUIDE 7F SR4.0 LAUNCHER CATHETER LA7SR40 LA 7F 100CM SR40 Coronary Guiding catheter designed to provide a pathway through which therapeutic and/or diagnostic devices are int
• Z-0977-06 · Apr 5, 2006 · Terminated
  CATH. GUIDE 7F SR4.0 W/SH LAUN CATHETER LA7SR40SH LA 7F 100CM SR40 Coronary Guiding catheter designed to provide a pathway through which therapeutic and/or diagnostic devices are
• Z-0973-06 · Apr 5, 2006 · Terminated
  CATH. GUIDE 7F SR3.0 W/SH LAUN CATHETER LA7SR30SH LA 7F 100CM SR30 Coronary Guiding catheter designed to provide a pathway through which therapeutic and/or diagnostic devices are
• Z-0974-06 · Apr 5, 2006 · Terminated
  CATH. GUIDE 7F SR3.5 LAUNCHER CATHETER LA7SR35 LA 7F 100CM SR35 Coronary Guiding catheter designed to provide a pathway through which therapeutic and/or diagnostic devices are int
• Z-0970-06 · Apr 5, 2006 · Terminated
  CATHETER LA7IMAA LA 7F 110CM I CATHETER LA7IMAA LA 7F 110CM IMA Coronary Guiding catheter designed to provide a pathway through which therapeutic and/or diagnostic devices are int
• Z-0980-06 · Apr 5, 2006 · Terminated
  CATH. GUIDE 7F SR5.0 LAUNCHER CATHETER LA7SR50 LA 7F 100CM SR50 Coronary Guiding catheter designed to provide a pathway through which therapeutic and/or diagnostic devices are int