Launcher LA7AL75Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00613994834065), received between Nov 6, 2017 and Nov 6, 2017 — classified as 1 injury.

The most frequently reported specific device problem is “Material Distortion” (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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryNov 6, 2017Material Distortion; Material Torqued; Material Distortion; Material Torqued

  THE PHYSICIAN USED A 7F LAUNCHER GUIDE CATHETER TO TREAT A MODERATELY TORTUOUS, MODERATELY CALCIFIED LESION IN THE PROXIMAL-MID RCA. THE PATIENT HAD PERIPHERAL ARTERY DISEASE (PAD) AND AN OCCLUDED SUPERFICIAL FEMORAL ARTERY (SFA). THERE WAS NO DAMAGE NOTED TO PACKAGING. THE DEVICE WAS REMOVED FROM PACKAGING PER IFU WITH NO ISSUES. THE DEVICE WAS INSPECTED WITH NO ISSUES. THE DEVICE WAS PREPPED PER IFU WITH NO ISSUES. RESISTANCE WAS NOT ENCOUNTERED WHEN ADVANCING THE DEVICE. EXCESSIVE FORCE WAS USED AND THE DEVICE WAS EXCESSIVELY TORQUED. IT IS REPORTED THAT THE PROXIMAL END OF THE CATHETER KINKED WHILE IN THE PATIENT. THE ILIAC ARTERY WAS DISSECTED AS A RESULT. PRESSURE WAS APPLIED TO THE GROIN SITE AND A LONG SHEATH WAS LEFT IN PLACE AND SEWN IN AT THE ACCESS SITE FOR TAMPONADE. NO BREAKAGE OF THE DEVICE OCCURRED. NO PORTION OF THE DEVICE DETACHED. IT IS REPORTED THAT A DEVICE MALFUNCTION IS NOT SUSPECTED - RATHER THAT THE ISSUE WAS A RESULT OF EXCESSIVE TORQUE.

  Patient problems: Vascular Dissection

  MAUDE report 7003391 ↗

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-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-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-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-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-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-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-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-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-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