Launcher LA7EBU30Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00613994834782), received between Feb 6, 2019 and Apr 11, 2024 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Use of Device Problem” (2 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 11, 2024Use of Device Problem; Use of Device Problem

  AN ATTEMPT WAS MADE TO USE ONE 7F LAUNCHER GUIDE CATHETER DURING A PROCEDURE. THE DEVICE WAS INSPECTED WITH NO ISSUES. THE DEVICE WAS  PREPPED PER IFU WITH NO ISSUES. IT WAS REPORTED THAT THE LAUNCHER GUIDE CATHETER WAS EXPIRED WHEN USED. THE PATIENT IS ALIVE WITH NO INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19085849 ↗
• MalfunctionOct 27, 2021Use of Device Problem; Use of Device Problem

  AN ATTEMPT WAS MADE TO USE A LAUNCHER GUIDE CATHETER. IT WAS REPORTED THAT THE DEVICE HAD EXPIRED DURING THE TIME OF USAGE. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12703865 ↗
• MalfunctionFeb 6, 2019Material Deformation; Material Deformation

  A LA7EBU30 LAUNCHER GUIDE CATHETER WAS USED FOR A PHYSICIAN-EVALUATED CADAVER STUDY AS PART OF A PRE-CLINICAL STUDY. THE UNIT WAS REMOVED FROM PACKAGING WITH NO ISSUES NOTED. THE PHYSICIAN INSERTED THE GUIDE CATHETER THROUGH AN INTRODUCER INTO THE RIGHT FEMORAL ARTERY. THE PHYSICIAN TRACKED THE DEVICE INTO THE CORONARY OSTIUM AND SPENT APPROX. 10 MINUTES ATTEMPTING TO CANNULATE THE LEFT CORONARY ARTERY. THE PHYSICIAN WAS UNABLE TO PLACE THE GUIDE CATHETER TIP WITHIN THE CORONARY ARTERY. THEY ATTEMPTED TO INJECT SOME CONTRAST THROUGH THE GUIDE AND NOTED THAT THEY COULD NOT INJECT. THERE WAS SOME OBSTRUCTION AND THEY THOUGHT THE GUIDE MIGHT BE KINKED. THE UNIT WAS REMOVED FROM THE CADAVER MODEL. ON REMOVAL, IT WAS NOTED THAT FLATTENING AND TORSIONAL KINKING OF THE UNIT HAD TAKEN PLACE. IT IS INDICATED THAT THE DEVICE WAS NOT EXCESSIVELY TORQUED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8310163 ↗

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-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
• 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-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-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-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-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-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-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-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-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-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-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