Fast-Cath™ 406306Recalls & reported problems

Summary

The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 05414734203920), received between Jun 28, 2018 and Dec 4, 2024 — classified as 2 injuries, 13 malfunctions.

The most frequently reported specific device problem is “Material Separation” (7 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 15 most recent of 15 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 4, 2024Gas/Air Leak; Gas/Air Leak

  DURING THE SUPRAVENTRICULAR TACHYCARDIA PROCEDURE, AIR WAS ASPIRATED WHEN FLUSHING THE INSIDE OF THE SHEATH. THE SHEATH WAS REPLACED AND THE PROCEDURE WAS COMPLETED WITH NO ADVERSE CONSEQUENCES TO THE PATIENT. THE HOSPITAL DISCARDED THE REPORTED SHEATH. AIR CONTAMINATION TO THE PATIENT HAS NOT BEEN CONFIRMED. NO ADDITIONAL PUNCTURE WAS PERFORMED DUE TO REPLACING THE INTRODUCER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20842725 ↗
• InjuryDec 20, 2022Material Separation; Material Separation

  DURING THE ATRIAL FLUTTER AND IMPLANTATION OF INTERNAL CARDIAC DEFIBRILLATOR SYSTEM, UPON REMOVAL OF THE RIGHT FEMORAL VENOUS SHEATH SIZE 12FR, THE DISTAL PORTION TORE FROM THE PROXIMAL HALF. THE DISTAL PORTION OF THE SHEATH WAS RETAINED WITHIN THE FEMORAL VEIN. THE SURGEON REPORTED THAT HE UTILIZED THE 3 PORT SHEATH SYSTEM IN THE SAME FASHION THAT HE NORMALLY DID. THIS TIME, WHEN ATTEMPTING TO REMOVE THE SHEATH, IT SEPARATED INSIDE THE VEIN. HE HAD THE TEAM HOLD PRESSURE AT THE SITE TO KEEP THE BROKEN SHEATH PIECE FROM MIGRATING. VASCULAR SURGERY CAME AND REMOVED THE SHEATH IN ONE PIECE AND CLOSED THE VEIN. THE PATIENT TOLERATED THE PROCEDURE WITHOUT FURTHER COMPLICATION.

  Patient problems: Foreign Body In Patient; Hematoma

  MAUDE report 16016182 ↗
• MalfunctionMar 25, 2022Gas/Air Leak; Gas/Air Leak

  DURING A PAROXYSMAL SUPRAVENTRICULAR TACHYCARDIA PROCEDURE, AIR WAS ASPIRATED FROM THE HEMOSTASIS VALVE. 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 13897383 ↗
• MalfunctionJan 24, 2022Fluid/Blood Leak; Fluid/Blood Leak

  DURING THE ATRIAL FLUTTER ABLATION PROCEDURE, BLOOD WAS LEAKING FROM THE HEMOSTASIS VALVE. 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 13338828 ↗
• MalfunctionApr 21, 2021Difficult to Insert; Difficult to Insert

  DURING A SUPRAVENTRICULAR TACHYCARDIA ABLATION PROCEDURE, THE NON ABBOTT CATHETER WAS DIFFICULT TO INSERTION INTO THE HEMOSTASIS VALVE FOLLOWING INSERTION INTO THE PATIENT WHICH CAUSED A DELAY. AN ATTEMPT TO INSERT ANOTHER NON-ABBOTT CATHETER DID NOT RESOLVE THE ISSUE. THE SHEATH SET 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 11702850 ↗
• MalfunctionMar 15, 2021Material Separation; Material Separation

  DURING THE PROCEDURE, THE HUB OF THE INTRODUCER SEPARATED FROM THE SHAFT UPON REMOVAL FROM THE PATIENT. THE DISLODGEMENT OCCURRED AFTER THE CONCLUSION OF THE PROCEDURE WITH NO EXCESS FORCE UTILIZED. THERE WERE NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11483587 ↗
• MalfunctionSep 21, 2020Material Frayed; Material Frayed

  DURING THE PROCEDURE, THE SHEATH COULD NOT BE INSERTED INTO THE BLOOD VESSEL. WHEN THE INTRODUCER WAS REMOVED FROM THE PATIENT, THE TIP OF THE SHEATH WAS FOUND TO BE FRAYED. THE INTRODUCER WAS REPLACED VIA A SECOND ACCESS SITE AND THE PROCEDURE WAS COMPLETED WITH NO ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10559938 ↗
• MalfunctionJul 9, 2020Material Separation; Material Separation

  DURING THE PROCEDURE, THE SHEATH OF THE INTRODUCER DISLODGED FROM THE HUB. THE PROCEDURE HAD FINISHED AND THE DETACHMENT WAS NOTED AFTER WITHDRAWING THE SHEATH FROM THE PATIENT. THERE WERE NO PATIENT CONSEQUENCES.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10254510 ↗
• MalfunctionJun 30, 2020Material Separation; Material Separation

  A DEVICE INCIDENT REPORT (DIR 63898) WAS REPORTED TO TGA BY AN UNKNOWN HCP/USER. DURING A CRYO-ABLATION PROCEDURE, THE INTRODUCER WAS DEPLOYED INTO THE LEFT FEMORAL VEIN. UPON REMOVAL OF THE SHEATH FROM THE ACCESS SITE, IT WAS NOTED THAT THE 12.5 CM SHAFT HAD BECOME DETACHED FROM THE HUB OF THE SHEATH.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10215018 ↗
• InjuryMay 7, 2020Material Separation; Material Separation

  DURING A PROCEDURE, WHEN REMOVING THE INTRODUCER, THE SHAFT BECAME SEPARATED FROM THE HUB OF THE SHEATH AND REMAINED INSIDE THE PATIENT'S VEIN. SURGICAL INTERVENTION, ALONG WITH FLUOROSCOPY, WAS REQUIRED TO REMOVE THE DETACHED PORTION OF THE SHEATH. THE PATIENT REMAINED IN STABLE CONDITION.

  Patient problems: Foreign Body In Patient

  MAUDE report 10032114 ↗
• MalfunctionMar 6, 2020Material Separation; Material Separation

  DURING DEVICE PREPARATION, THE IRRIGATION TUBE BECAME DETACHED FROM THE INTRODUCER. 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 9799938 ↗
• MalfunctionFeb 14, 2020Material Separation; Material Separation

  WHEN REMOVING THE INTRODUCER FROM THE PATIENT AFTER THE PROCEDURE, THE SHEATH HUB DETACHED ABOVE THE THREE VALVES. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9712120 ↗
• MalfunctionMay 3, 2019Fluid/Blood Leak; Fluid/Blood Leak

  DURING A PAROXYSMAL SUPRAVENTRICULAR TACHYCARDIA PROCEDURE, WHEN THE SHEATH WAS REMOVED FROM THE PATIENT, A BLOOD LEAK WAS NOTED FROM THE MIDDLE OF THE SHEATH. THE SHEATH WAS INSPECTED AND A SMALL CRACK WAS FOUND ON THE SHEATH TUBING. THE PROCEDURE WAS COMPLETED WITHOUT REPLACING THE INTRODUCER AND THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8577283 ↗
• MalfunctionMar 12, 2019Fluid/Blood Leak; Fluid/Blood Leak

  DURING THE PROCEDURE, A BLOOD LEAK WAS NOTED FROM THE HEMOSTASIS VALVE. THE DEVICE WAS REPLACED TO A NON-ABBOTT SHEATH AND THE PROCEDURE WAS COMPLETED WITH NO ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8412004 ↗
• MalfunctionJun 28, 2018Gas/Air Leak; Gas/Air Leak

  DURING A VENTRICULAR TACHYCARDIA PROCEDURE AN AIR LEAK OCCURRED. FOLLOWING SHEATH INSERTION, AIR WAS ASPIRATED INTO THE SYRINGE CONNECTED TO THE EXTENSION PORT OF THE SHEATH. ASPIRATION ATTEMPTS TO REMOVE THE AIR PROVIDED NO RESOLUTION. A NEW SHEATH SET WAS USED TO CONTINUE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7645369 ↗