Fast-Cath™ 406962Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 05414734204040), received between Apr 1, 2020 and Apr 23, 2024 — classified as 1 injury, 6 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (3 reports).

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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 23, 2024Material Separation; Material Separation

  DURING A PAROXYSMAL SUPRAVENTRICULAR TACHYCARDIA PROCEDURE, THE TRIO ADAPTER WAS DETACHED WHEN THE SHEATH WAS CONNECTED AND FLUSHED BEFORE INSERTION INTO THE PATIENT. AFTER RECONNECTING AND INSERTING THE SHEATH INTO THE VEIN, THE TRIO ADAPTER DETACHED AGAIN WHILE INSERTING THE INQUIRY CATHETER (IBI-81251). THE SHEATH WAS REPLACED AND THE PROCEDURE WAS COMPLETED WITH NO ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19168889 ↗
• MalfunctionMay 17, 2023Fluid/Blood Leak; Fluid/Blood Leak

  DURING THE PAROXYSMAL SUPRAVENTRICULAR TACHYCARDIA PROCEDURE, A BLOOD LEAK WAS NOTED FROM THE HEMOSTASIS VALVE OF THE WHITE HEMOSTASIS VALVE HUB. THE INTRODUCER WAS REPLACED, AND THE PROCEDURE WAS COMPLETED WITH NO ADVERSE CONSEQUENCES TO THE PATIENT. NO ADDITIONAL VENIPUNCTURE WAS PERFORMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16947725 ↗
• MalfunctionAug 31, 2021Gas/Air Leak; Gas/Air Leak

  RELATED MANUFACTURING REF: 3005334138-2021-00562. DURING A PAROXYSMAL SUPRAVENTRICULAR TACHYCARDIA (PSVT) ABLATION PROCEDURE, AN AIR LEAK OCCURRED. FOLLOWING INSERTION OF THE SHEATH INTO THE PATIENT AND PRIOR TO INSERTING CATHETERS INTO THE SHEATH, AIR WAS ASPIRATED INTO THE SYRINGE THAT CONNECTED TO THE EXTENSION PORT OF THE SHEATH. SEVERAL ASPIRATIONS WERE ATTEMPTED BUT THE AIR REMAINED. THE SHEATH SET WAS REPLACED WITH A DEVICE FROM THE SAME LOT NUMBER, AND THE SAME ISSUE OCCURRED. A THIRD SHEATH WAS USED TO COMPLETE THE PROCEDURE WITH NO CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12391885 ↗
• MalfunctionAug 31, 2021Fluid/Blood Leak; Gas/Air Leak; Fluid/Blood Leak; Gas/Air Leak

  RELATED MANUFACTURING REF: 3005334138-2021-00563. DURING A PAROXYSMAL SUPRAVENTRICULAR TACHYCARDIA (PSVT) ABLATION PROCEDURE, AN AIR LEAK OCCURRED. AFTER PLACING THE SHEATH INTO THE PATIENT AND PRIOR TO INSERTING CATHETERS INTO THE SHEATH, AIR WAS ASPIRATED INTO THE SYRINGE THAT CONNECTED TO THE EXTENSION PORT OF THE SHEATH. SEVERAL ASPIRATIONS WERE ATTEMPTED BUT THE AIR REMAINED. THE SHEATH SET WAS REPLACED WITH A DEVICE FROM THE SAME LOT NUMBER, AND THE SAME ISSUE OCCURRED. THE SECOND SHEATH WAS REPLACED AND THE PROCEDURE WAS COMPLETED WITH NO ADVERSE CONSEQUENCES TO THE PATIENT. NO ADDITIONAL FEMORAL VEIN PUNCTURE WAS REQUIRED FOR REPLACING THE SHEATH.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12391873 ↗
• MalfunctionSep 15, 2020Fluid/Blood Leak; Fluid/Blood Leak

  DURING AN ATRIAL TACHYCARDIA ABLATION PROCEDURE, BLOOD WAS LEAKING FROM THE HEMOSTASIS VALVE OF THE GREEN CAPPED PORT. THE INTRODUCER WAS REPLACED AND THE PROCEDURE WAS COMPLETED WITH NO ADVERSE CONSEQUENCES TO THE PATIENT. NO ADDITIONAL PUNCTURE WAS REQUIRED FOR THIS REPLACEMENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10537393 ↗
• InjuryJun 23, 2020Connection Problem; Connection Problem

  DURING THE PROCEDURE AFTER THE PUNCTURE, THE TRIPLE-HEMOSTASIS VALVES AND SHEATH WERE NOT CONNECTED PROPERLY, IT WAS NOT STRAIGHT. THREE 5FR SHEATHS WERE USED TO COMPLETE THE PROCEDURE INSTEAD AND THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. THREE ADDITIONAL ACCESS SITES WERE REQUIRED FOR THE REPLACEMENT DEVICES DUE TO THE MALFUNCTION. FURTHER INFORMATION REGARDING THE EVENT IS PENDING.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10184503 ↗
• MalfunctionApr 1, 2020Material Separation; Material Separation

  DURING DEVICE PREPARATION, THE SIDEPORT WAS DETACHED FROM THE HUB. THE INTRODUCER WAS REPLACED AND THE PROCEDURE WAS COMPLETED WITH NO ADVERSE CONSEQUENCES TO THE PATIENT. THE HOSPITAL DISCARDED THE REPORTED DEVICE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9909965 ↗