Launcher LA7JL40Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00613994832030), received between Jul 15, 2025 and Dec 1, 2025 — classified as 1 injury, 2 malfunctions.

The most frequently reported specific device problem is “Difficult to Remove” (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.

• MalfunctionDec 1, 2025Use of Device Problem; Use of Device Problem

  IT WAS REPORTED THAT AN EXPIRED 7F LAUNCHER GUIDING CATHETER WAS USED DURING AN ANGIOPLASTY PROCEDURE. THE DEVICE HAD EXPIRED PRIOR TO THE PROCEDURE, AND THIS WAS DISCOVERED WHEN THE BATCH NUMBER WAS TRACED FOR BILLING PURPOSES. THE CATHETER REMOVED FROM PACKAGING PER INSTRUCTIONS FOR USE WITH NO ISSUES, AND IT WAS PREPPED ACCORDING TO INSTRUCTIONS WITH NO ISSUES. NO RESISTANCE WAS ENCOUNTERED DURING ADVANCEMENT, AND NO EXCESSIVE FORCE WAS USED DURING INSERTION. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23687064 ↗
• InjuryAug 6, 2025Difficult to Remove; Deformation Due to Compressive Stress; Detachment of Device or Device Component; Material Deformation; Material Split, Cut or Torn; Difficult to Remove; Deformation Due to Compressive Stress; Detachment of Device or Device Component; Material Deformation; Material Split, Cut or Torn

  IT WAS REPORTED THAT DURING A PERCUTANEOUS CORONARY INTERVENTION (PCI) PROCEDURE INVOLVING ONE 7F LAUNCHER GUIDE CATHETER, THE CATHETER KINKED IN THE RADIAL ARTERY WHEN CLOCKING FOR THE PROCEDURE. THE LESION BEING TREATED WAS LOCATED IN THE OSTIAL/PROXIMAL LEFT ANTERIOR DESCENDING (LAD) LESION. THE PATIENT HAD AN INTRA-AORTIC BALLOON PUMP ALREADY IN PLACE RIGHT FEMORAL BUT NO WIRE WAS ADVANCED IN THE CORONARY ARTERY YET. THE PCI WAS ABORTED AFTER THE LAUNCHER GUIDE CATHETER BECAME ENTRAPPED IN THE RIGHT FOREARM DUE TO CATHETER MANIPULATION. ATTEMPTS WERE MADE TO STRAIGHTEN OUT THE CATHETER BUT FAILED DESPITE THE USE OF MULTIPLE WIRES. AN ATTEMPT WAS MADE TO ADVANCE A 7F AND A 8F DILATOR OVER THE GUIDE CATHETER WITHOUT SUCCESS. VASCULAR SURGERY WAS REQUESTED TO ASSIST WITH RETRIEVAL OF THE DEVICE. A RADIAL CUT-DOWN WAS PERFORMED AND REMOVED THE CATHETER IN TWO PIECES. THE RADIAL ARTERY WAS SUTURED. AN ARTERIAL DOPPLER CONFIRMED ROBUST ULNAR ARTERIAL PULSATION. NO FURTHER INTERVENTION WAS PERFORMED. THE LAD PCI WAS COMPLETED THE FOLLOWING DAY. IT WAS BELIEVED THAT THIS EVENT COULD BE DUE TO THE RADIAL ACCESS BEING MORE TORTUROUS AND GUIDE CATHETERS BEING THINNER WALLED THAN OTHER CAT

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22725760 ↗
• MalfunctionJul 15, 2025Positioning Failure; Difficult to Remove; Failure to Advance; Malposition of Device

  FROM STAFF: A GUIDE CATHETER KINKED IN THE RADIAL ARTERY WHEN CLOCKING FOR THE PROCEDURE. THIS ULTIMATELY REQUIRED A VASCULAR DOCTOR TO COME AND DO A CUT-DOWN AND LIGATION OF THE RADIAL ARTERY. THIS WAS DURING A PCI [PERCUTANEOUS CORONARY INTERVENTION] ATTEMPT FOR AN OSTIAL LEFT ANTERIOR DESCENDING LESION, ON A PATIENT WITH AN INTRA-AORTIC BALLOON PUMP ALREADY IN PLACE RIGHT FEMORAL. WE HAD NOT YET GOTTEN VERY FAR IN THE ATTEMPT; NO WIRE WAS ADVANCED INTO THE CORONARY ARTERY YET. I THINK THIS EVENT HAPPENED BECAUSE OF RADIAL ACCESS BEING MORE TORTUROUS, GUIDE CATHETERS BEING THINNER WALLED THAN OTHER CATHETERS, POSSIBLE EQUIPMENT FAILURE (GUIDE CATHETER). THIS IS SOMEWHAT UNAVOIDABLE, ALTHOUGH IT COULD BE MITIGATED BY PREFERENTIALLY USING FEMORAL ACCESS IN CASES LIKE THIS, ALTHOUGH THAT WOULD INCREASE THE RISK OF LIFE-THREATENING HEMATOMA OR RETROPERITONEAL BLEED, SO IT MAY NOT BE BENEFICIAL TO PREFER FEMORAL ACCESS. FROM OPERATIVE REPORT: ABORTED PCI ATTEMPT OF PROXIMAL LAD [LEFT ANTERIOR DESCENDING] AFTER GUIDE CATHETER BECAME ENTRAPPED IN THE RIGHT FOREARM DUE TO CATHETER MANIPULATION. ATTEMPTS TO STRAIGHTEN OUT THE CATHETER FAILED DESPITE USE OF MULTIPLE WIRES. WE ALSO TRIED AD

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22505857 ↗

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-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-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-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-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-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-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-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-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-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-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-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