Fast-Cath™ 406137Recalls & reported problems

Summary

The FDA's MAUDE database contains 22 adverse event reports that list this exact device (DI 05414734012751), received between Jun 22, 2018 and Dec 8, 2025 — classified as 3 injuries, 19 malfunctions.

The most frequently reported specific device problem is “Material Separation” (14 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 22 most recent of 22 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 8, 2025Material Separation; Material Separation

  THIS REPORT INCLUDES AN UPDATED ANALYSIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23749986 ↗
• InjuryOct 15, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT AFTER BEING POSITIONED IN THE PATIENT FOR A FEW HOURS, THE SIDEPORT TUBING DETACHED FROM THE INTRODUCER. THE INTRODUCER WAS REPLACED WHICH RESOLVED THE ISSUE. THE PATIENT EXPERIENCED BLOOD LOSS ACCOMPANIED BY A DROP IN HEMOGLOBIN LEVEL WHICH DID NOT REQUIRE ANY INTERVENTION.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 23303397 ↗
• MalfunctionSep 10, 2025Fluid/Blood Leak; Material Separation; Fluid/Blood Leak; Material Separation

  DURING THE PROCEDURE, IT WAS NOTED THAT THE FLUSHING AND INFUSION LINE WAS DETACHED FROM THE SHEATH CAUSING A FLUID LEAK. THE DEVICE FUNCTIONED AS INTENDED DURING THE PROCEDURE AND TRANSFER. ONCE IN THE ICU, IT BECAME EVIDENT THAT THE DEVICE WAS LOOSE. THE DEVICE WAS REMOVED AND EXCHANGED WITH NO CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23015863 ↗
• MalfunctionJul 1, 2025Material Separation; Material Separation

  WHILE GENTLE ROUTINE CLEANING OF THE TUBING WITH COMPRESSES FOR DEVICE BANDAGE REPLACEMENT, THE TUBING BECAME DETACHED. THE TUBING WAS PUT BACK ON AND THE DEVICE WAS REMOVED BY THE PHYSICIAN LATER THAT DAY. THERE WERE NO REPORTED ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22376322 ↗
• MalfunctionJun 12, 2025Gas/Air Leak; Gas/Air Leak

  DURING A PROCEDURE, IT WAS NOTED THAT THE INTRODUCER WAS LEAKING AIR. THE INTRODUCER WAS REPLACED AND THE PROCEDURE WAS COMPLETED WITH NO ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22194579 ↗
• MalfunctionJun 9, 2025Material Separation; Material Separation

  THE PATIENT UNDERWENT A BENTALL PROCEDURE DURING WHICH THE INTRODUCER WAS PLACED IN THE PATIENT. DURING ROUTINE MANIPULATION OF THE INTRODUCER, THE SIDEPORT SEPARATED FROM THE DEVICE. NO EXTRA FORCE WAS USED AND NO ANTISEPTIC WAS USED ON THE DEVICE. STERILE GLOVES AND A STERILE COMPRESS WERE INITIALLY USED TO BLOCK THE HOLE AT THE POINT OF SEPARATION, THEN A 3-WAY EXTENSION WAS FORCIBLY CONNECTED TO PREVENT AIR INTRUSION. THE INTRODUCER WAS REPLACED WHICH RESOLVED THE ISSUE AND THE PROCEDURE WAS COMPLETED WITH NO ADVERSE CONSEQUENCES TO THE PATIENT. IT IS UNKNOWN HOW LONG THE INTRODUCER WAS INSIDE THE PATIENT PRIOR TO THE REPORTED SIDEPORT DETACHMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22168185 ↗
• MalfunctionJun 7, 2025Material Separation; Material Separation

  THERE HAVE BEEN MULTIPLE SIDEPORT DETACHMENTS REPORTED BY THE CUSTOMER. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22162243 ↗
• MalfunctionJun 7, 2025Material Separation; Material Separation

  DURING THE PROCEDURE, THE SIDEPORT DETACHED FROM THE SHEATH. ANOTHER CATHETER WAS USED TO COMPLETED THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22162172 ↗
• MalfunctionJun 7, 2025Material Separation; Material Separation

  DURING THE PROCEDURE, THE SIDEPORT DETACHED FROM THE SHEATH. ANOTHER CATHETER WAS USED TO COMPLETED THE PROCEDURE. PER-(B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22162126 ↗
• InjuryJun 10, 2024Fracture; Fracture

  WHEN STARTING A PULMONARY VASOREACTIVITY TEST WITH DOSE ESCALATION OF NITROPRUSSIDE, WHICH IS ADMINISTERED THROUGH THE LUMEN OF A SWARTZ INTRODUCER, THE PATIENT REPORTED PAIN AT THE INSERTION SITE OF THE INTRODUCER, AT THE RIGHT JUGULAR. INFILTRATION OF MEDICATION WAS EVIDENT. MEASUREMENTS WERE SUSPENDED AND WHEN REMOVING THE INTRODUCER, A CRACK WAS OBSERVED IN THE MEDICAL DEVICE.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 19507016 ↗
• InjuryApr 8, 2022Material Separation; Material Separation

  DURING AN ATRIAL FIBRILLATION PROCEDURE, RESISTANCE WAS NOTED AND THE SHEATH TUBE DETACHED APPROXIMATELY 9CM PROXIMAL TO THE TIP DURING INSERTION INTO RIGHT FEMORAL VEIN. A BALLOON CATHETER WAS INSERTED INTO THE SHEATH AND INFLATED TO REMOVE THE DETACHED PORTION OF THE FROM THE PATIENT. A NON ABBOTT SHEATH WAS THEN INSERTED FROM THE LEFT FEMORAL VEIN AND THE PROCEDURE WAS COMPLETED WITH NO ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: Foreign Body Embolism; Foreign Body In Patient

  MAUDE report 14052518 ↗
• MalfunctionNov 4, 2021Gas/Air Leak; Gas/Air Leak

  DURING ATRIAL FIBRILLATION PROCEDURE, AN AIR LEAK OCCURRED. AFTER PLACING THE SHEATH, PRIOR TO INSERTING CATHETERS, AIR WAS ASPIRATED INTO A SYRINGE THAT CONNECTED TO THE EXTENSION PORT OF THE SHEATH. SEVERAL ASPIRATIONS WERE ATTEMPTED BUT THE AIR WAS STILL ASPIRATED. THE SHEATH SET WAS REPLACED AND THE PROCEDURE WAS COMPLETED WITH NO ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12752404 ↗
• MalfunctionFeb 24, 2021Material Separation; Material Separation

  DURING DEVICE PREPARATION, THE SIDEPORT OF THE INTRODUCER DETACHED. THE DEVICE WAS REPLACED AND THE ISSUE WAS RESOLVED. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11375948 ↗
• MalfunctionFeb 24, 2021Material Separation; Material Separation

  DURING THE PROCEDURE, THE SIDEPORT OF THE INTRODUCER DETACHED. THE DEVICE WAS EXCHANGED AND THE ISSUE WAS RESOLVED. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11375938 ↗
• MalfunctionFeb 10, 2021Material Separation; Material Separation

  FOLLOWING THE PROCEDURE, IT WAS NOTED THAT THE SIDEPORT DETACHED. DURING THE PROCEDURE, A CATHETER WAS PLACED PRIOR TO RECEIVING AN LVAD. THE CATHETER WAS REMOVED AND THE INTRODUCER WAS LEFT IN PLACE. FOLLOWING THE PROCEDURE, BLEEDING WAS NOTED, THE DRESSING WAS REMOVED AND THE SIDEPORT OF THE INTRODUCER WAS NOTED TO BE BROKEN. NO TREATMENT WAS NECESSARY TO STOP THE BLEEDING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11311525 ↗
• MalfunctionJan 5, 2021Material Separation; Material Separation

  DURING LONG-TERM IN-PATIENT USE OF THE INTRODUCER, A SIDEPORT DETACHMENT WAS NOTED. THE CONNECTION OF THE SIDEPORT TO THE INTRODUCER SHEATH CRACKED CAUSING THE CATHETER TO SEPARATE FROM THE INTRODUCER. A CAP WAS PLACED ON THE SITE OF THE BREAK. THE PATIENT EXPERIENCED NO ADVERSE CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 11121040 ↗
• MalfunctionJun 23, 2020Material Puncture/Hole; Material Puncture/Hole

  DURING THE PROCEDURE, A HOLE WAS NOTED AT THE SHAFT 1CM DISTAL TO THE BASAL OF THE EXTENSION TUBING OF THE INTRODUCER WHEN INSERTING THE INTRODUCER INTO A PATIENT. THE INTRODUCER WAS REPLACED AND THE PROCEDURE WAS COMPLETED WITH NO ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10184862 ↗
• MalfunctionApr 19, 2019Fracture; Detachment of Device or Device Component; Fracture; Detachment of Device or Device Component

  WHILE IN THE PATIENT ANATOMY, THE IRRIGATION PORT DETACHED FROM SHEATH. THE PATIENT COMPLAINED OF THEIR "IV LEAKING", IT WAS NOTED THE IRRIGATION PORT WAS DETACHED FROM THE SHEATH. PRESSURE WAS APPLIED TO THE SITE AND THE SHEATH WAS REMOVED WITH NO PATIENT CONSEQUENCES. THE SIDEPORT OF THE SHEATH WAS ALSO NOTED TO BE CRACKED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8532819 ↗
• MalfunctionApr 19, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  THE TUBING OF THE INTRODUCER WAS FOUND DETACHED AT THE IRRIGATION PORT OF THE SHEATH WHILE IN THE PATIENT. THE PATIENT COMPLAINED OF FEELING "WET" AND THE NURSE FOUND THE DETACHED IRRIGATION PORT. PRESSURE WAS APPLIED OVER THE DRESSING, THE PATIENT WAS PLACED IN TRENDELENBERG AND THE INTRODUCER WAS REMOVED WITH NO CONSEQUENCES TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8532804 ↗
• MalfunctionMar 5, 2019Material Separation; Material Separation

  DURING A PROCEDURE THE SIDEPORT WAS NOTED TO BE DETACHED FROM THE INTRODUCER. THE SHEATH WAS REPLACED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8391294 ↗
• MalfunctionOct 2, 2018Detachment of Device or Device Component; Detachment of Device or Device Component

  THE TUBING OF THE FAST-CATH HEMOSTASIS INTRODUCER DETACHED. THE DEVICE WAS EASILY REMOVED. ADMINISTRATION OF CORDARONE AND LOXEN MEDICATION WAS STOPPED AND A SLIGHT INCREASE OF PRESSURE IN THE PATIENT WAS NOTICED. AN EMERGENCY PERIPHERAL LINE WAS PLACED TO RESTORE MEDICATION ADMINISTRATION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7927257 ↗
• MalfunctionJun 22, 2018Detachment Of Device Component; Detachment Of Device Component

  THE FAST-CATH HEMOSTASIS INTRODUCER BECAME DETACHED AT THE SIDE TUBING. THE PATIENT REPORTED LIQUID FLOWING IN AND ON THEIR NECK RIGHT AWAY. THE FAST-CATH HEMOSTASIS INTRODUCER WAS REMOVED WITHOUT ANY INTERVENTIONS. ANOTHER FAST-CATH HEMOSTASIS CATHETER WAS USED. PATIENT IDENTIFIERS COULD NOT BE COLLECTED DUE TO (B)(6) LOCAL REGULATION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7630837 ↗