Launcher LA7EBU35Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00613994834713), received between Jan 21, 2019 and Jan 4, 2022 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Material Deformation” (1 report).

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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryJan 4, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AN ATTEMPT WAS MADE TO USE TWO LAUNCHER GUIDE CATHETERS TO TREAT A SEVERELY TORTUOUS, MODERATELY CALCIFIED LESION WITH 100% CTO (CHRONIC TOTAL OCCLUSION) IN THE MID LEFT ANTERIOR DESCENDING (LAD) ARTERY AND CIRCUMFLEX (CX) ARTERY. THE DEVICE WAS INSPECTED WITH NO ISSUES NOTED. (B)(6) PREP WAS PERFORMED WITH NO ISSUES. RESISTANCE WAS ENCOUNTERED WHEN ADVANCING THE DEVICE. EXCESSIVE FORCE WAS USED DURING DELIVERY. THE LESION WAS ALSO TREATED WITH THREE NON-MEDTRONIC GUIDEWIRES, A NON-MEDTRONIC BALLOON AND A NON-MEDTRONIC CUTTING BALLOON. A NON-MEDTRONIC MICRO CATHETER WAS ALSO USED DURING THE PROCEDURE. IT WAS REPORTED THAT A VESSEL OCCLUSION OCCURRED DUE TO A DEVICE COMPONENT. IT WAS ALSO REPORTED THAT THROMBOSIS/CLOTS OCCURRED AFTER THE PROCEDURE IN THE LAD. THE PHYSICIAN SUGGESTED THE ADVERSE EVENT IS DEVICE RELATED, AS CLOT HAS OCCURRED AFTER THE USE OF THE LAUNCHER DURING THE PROCEDURE. THE PATIENT WAS ON DAPT AT THE TIME OF THE EVENT. THE EVENT WAS TREATED WITH ANTI THROMBOLYTIC AGENTS. NO FURTHER PATIENT INJURY AS REPORTED.

  Patient problems: Obstruction/Occlusion; Perforation; Thrombosis/Thrombus; Vascular Dissection

  MAUDE report 13151538 ↗
• MalfunctionJan 21, 2019Material Deformation; Material Deformation

  A 7F LAUNCHER GUIDE CATHETER WAS USED IN A PROCEDURE TO TREAT A LESION IN THE LAD. 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. MILD RESISTANCE WAS ENCOUNTERED WHEN ADVANCING THE DEVICE. EXCESSIVE FORCE WAS NOT USED DURING DELIVERY. IT IS REPORTED THAT THE CATHETER KINKED WHILE ADVANCING IN THE ARTERY. NO PATIENT INJURY IS REPORTED. THE PROCEDURE WAS COMPLETED USING ANOTHER 7F LAUNCHER DEVICE. ANALYSIS OF THE RETURNED DEVICE REVEALED A TORSIONAL KINK ON THE DEVICE, 25CM FROM THE PROXIMAL HUB.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8264089 ↗

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-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-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-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-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-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-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-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-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-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-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-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-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