Fast-Cath™ 406702Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 05414734216951), received between Sep 19, 2019 and Mar 19, 2025 — classified as 5 injuries, 5 malfunctions.

The most frequently reported specific device problem is “Material Separation” (8 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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 19, 2025Material Separation; Material Separation

  AFTER AN ATYPICAL FLUTTER IN THE RIGHT ATRIUM, AFTER THE PHYSICIAN TAKE OUT ALL THE CATHETERS FROM THE PATIENT, HE TRIED TO TAKE OUT THE INTRODUCER BUT NOTED IT WAS DAMAGED. THE INTRODUCER WAS SPLIT IN TWO PIECES. THERE ARE NO PICTURES AVAILABLE. THERE WAS NO ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21645864 ↗
• MalfunctionJun 18, 2024Fracture; Fracture

  DURING THE PREMATURE VENTRICULAR CONTRACTION PROCEDURE, WHILE PERFORMING THE GROIN PUNCTURE IT WAS DISCOVERED THAT THE SHEATH WAS DAMAGED, IT LOOKED AS IF THE DILATOR HAD SLIT IT OPEN FROM THE INSIDE. 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 19558630 ↗
• InjuryJun 12, 2024Material Separation; Material Separation

  DURING THE PROCEDURE, WHILE CLOSING USING THE FIGURE 8 STITCH AS USUAL, THE SHEATH BROKE AND REQUIRED INTERVENTION TO SUCCESSFULLY RETRIEVE FROM THE PATIENT. THE PATIENT IS STABLE.

  Patient problems: Foreign Body In Patient

  MAUDE report 19524770 ↗
• MalfunctionJun 26, 2023Material Separation; Material Separation

  DURING AN ATRIAL FIBRILLATION PROCEDURE, STENOSIS WAS OBSERVED WITH THE 1ST FAST-CATH HEMOSTASIS INTRODUCER INSERTION AT THE RIGHT FEMORAL VEIN. BEFORE INSERTING THE 2ND FAST-CATH HEMOSTASIS INTRODUCER, IT WAS FOUND THAT THE TRANSSEPTAL NEEDLE HAD INADVERTENTLY PUNCTURED AND FRACTURED THE FIRST SHEATH. THE BROKEN SHEATH WAS REMOVED WITH A SNARE AND REPLACED WITH A NON-ABBOTT SHEATH TO COMPLETE THE PROCEDURE WITH NO ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: Foreign Body In Patient

  MAUDE report 17206299 ↗
• InjuryDec 21, 2022Material Separation; Material Separation

  DURING THE PROCEDURE, A PORTION OF SHEATH DETACHED IN THE PATIENT. THE PATIENT IS STABLE.

  Patient problems: Foreign Body Embolism; Foreign Body In Patient

  MAUDE report 16023005 ↗
• MalfunctionMay 11, 2022Fluid/Blood Leak; Material Twisted/Bent; Fluid/Blood Leak; Material Twisted/Bent

  DURING THE PROCEDURE, IT WAS NOTED THAT THERE WAS BLOOD FLOW BACK IN THE SHEATH AND THE FLUSH PORT WAS WARPED. THE PORT WAS CLAMPED WITH A PAIR OF HEMOSTATS TO STOP THE BACK FLOW AND THE CASE WAS COMPLETED WITH NO CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14359571 ↗
• InjuryApr 13, 2021Material Separation; Material Separation

  DURING AN ATRIAL FIBRILLATION ABLATION PROCEDURE UTILIZING A FEMORAL ACCESS SITE, WHEN ATTEMPTING TO REMOVE THE SHEATH RESISTANCE WAS NOTED AND WHEN FULLY REMOVED FROM THE PATIENT, A PART OF THE SHEATH WAS LEFT IN THE PATIENT. A SNARE WAS USED TO REMOVE THE BROKEN OFF PIECE AND THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. THE PROCEDURE WAS STILL NOTED TO HAVE BEEN COMPLETED. ALL OF THE PIECES WERE ACCOUNTED FOR WITH BOTH FLUOROSCOPY AND ECHOCARDIOGRAM. NO INSERTION DIFFICULTIES OR ANATOMICAL ISSUES WERE NOTICED WHEN INTRODUCING THE INTRODUCER.

  Patient problems: Foreign Body Embolism

  MAUDE report 11657799 ↗
• MalfunctionJan 14, 2021Material Separation; Material Separation

  DURING A VENTRICULAR TACHYCARDIA ABLATION, WHEN THE SHEATHS WERE PULLED FROM THE RIGHT FEMORAL VEIN WHILE HOLDING PRESSURE, IT WAS NOTED UNDER FLUOROSCOPY THAT THE INTRODUCER HAD SHEARED OFF AND THE LOWER HALF WAS RETAINED IN THE PATIENT. THE SHEATH PORTION WAS RETRIEVED AND REMOVED UNDER FLUOROSCOPY.

  Patient problems: Foreign Body Embolism; No Consequences Or Impact To Patient

  MAUDE report 11169929 ↗
• InjurySep 19, 2019Material Separation; Material Separation

  MANUFACTURER RELATED REF: 3005334138-2019-00511. DURING THE PROCEDURE, THE SHEATH BROKE INSIDE THE FEMORAL VEIN. A VASCULAR SURGEON WAS ABLE TO REMOVE THE SHEATH. A SECOND SHEATH WAS USED AND THE DEVICE KINKED AND FORMED IN THE DEVICE.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 9086474 ↗
• InjurySep 19, 2019Material Separation; Material Separation

  MANUFACTURER RELATED REF: 3005334138-2019-00512. DURING THE PROCEDURE, THE SHEATH BROKE INSIDE THE FEMORAL VEIN. A VASCULAR SURGEON WAS ABLE TO REMOVE THE SHEATH. A SECOND SHEATH WAS USED AND THE DEVICE KINKED AND FORMED IN THE DEVICE.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 9086461 ↗