Fast-Cath™ 406124Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 05414734014052), received between Jun 16, 2018 and May 19, 2022 — classified as 1 death, 3 malfunctions.

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

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.

• MalfunctionMay 19, 2022Fracture; Fracture

  FOLLOWING THE ATRIAL FIBRILLATION PROCEDURE, WHEN THE SHEATH WAS REMOVED FROM THE PATIENT, IT WAS NOTED THAT THERE WAS A SERRATION TYPE APPEARANCE AT THE EDGE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14437654 ↗
• MalfunctionMay 3, 2019Fluid/Blood Leak; Fluid/Blood Leak

  DURING THE PROCEDURE, THE VALVE ON THE INTRODUCER WAS LEAKING BLOOD. ANOTHER INTRODUCER WAS USED TO COMPLETE THE PROCEDURE WITH NO PATIENT CONSEQUENCES.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8579714 ↗
• DeathJan 10, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  RELATED MANUFACTURER REFERENCE NUMBER: 9680001-2018-00129, 9680001-2019-00004, 2182269-2019-00004, 3005334138-2019-00020, 3005334138-2019-00021, 3005334138-2019-00023. FOLLOWING AN ABLATION PROCEDURE, THE PATIENT EXPERIENCED A CEREBRAL INFARCTION AND EXPIRED. DURING THE PROCEDURE THE PATIENT WAS ANTICOAGULATED WITH HEPARIN AND THE ACT MONITORING WAS MADE IN 30-MINUTE INTERVALS. AFTER THE PROCEDURE THE PATIENT DID NOT WAKE UP FROM ANESTHESIA AND SUBSEQUENTLY EXPIRED. THERE WERE NO PERFORMANCE ISSUE WITH THE DEVICE. FURTHER INFORMATION HAS BEEN REQUESTED REGARDING THE CVA.

  Patient problems: Death; Myocardial Infarction; Stroke/CVA

  MAUDE report 8237255 ↗
• MalfunctionJun 16, 2018Disconnection; Disconnection

  WHILE REMOVING THE CATHETERS POST PROCEDURE FROM THE GROIN, THE FAST-CATH HEMOSTASIS INTRODUCER RIPPED. PART OF THE DEVICE WAS STILL IN THE PATIENT BUT ABLE TO BE REMOVED BECAUSE THE CATHETER WAS STILL IN THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7608457 ↗