Fast-Cath™ 406701Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 05414734216944), received between Mar 6, 2019 and Sep 12, 2025 — classified as 4 injuries, 5 malfunctions.

The most frequently reported specific device problem is “Material Separation” (4 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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• InjurySep 12, 2025Material Separation; Material Separation

  DURING AN ATRIAL FIBRILLATION PROCEDURE, A PORTION OF THE FAST-CATH INTRODUCER DETACHED AND REMAINED IN THE PATIENT. WHEN REMOVING A NON-ABBOTT (BOSTONSCIENTIFIC) FARADRIVE INTRODUCER & FARAWAVE CATHETER, AND FAST CATH INTRODUCER FROM THE RIGHT FEMORAL VEIN, THE FAST CATH INTRODUCER SNAPPED AND WAS LEFT WITHIN THE BODY. A VASCULAR SURGEON WAS REQUIRED TO PERFORM A CUT DOWN AT THE FEMORAL VEIN TO ATTEMPT TO RETRIEVE THE SEPARATED SHEATH. THIS WAS UNSUCCESSFUL. THE INTRODUCER WAS THEN RETRIEVED USING A SNARE AND REMOVED THROUGH THE NON-ABBOTT (BOSTONSCIENTIFIC) FARADRIVE INTRODUCER. THE PATIENT IS STABLE. IT IS ALLEGED BY THE PHYSICIAN THAT THE CAUSE WAS EITHER DUE TO THE PUNCTURES BEING TWO CLOSE AND THE NON-ABBOTT (BOSTONSCIENTIFIC) FARADRIVE INTRODUCER SQUISHED THE FAST CATH INTRODUCER OR THE INTRODUCER WAS SUTURED TOO TIGHTLY AND SNAGGED UPON REMOVAL. THE PHYSICIAN DID NOT ALLEGE AN PERFORMANCE ISSUES WITH THE ABBOTT INTRODUCER.

  Patient problems: Foreign Body In Patient

  MAUDE report 23043183 ↗
• InjuryOct 20, 2023Material Separation; Material Separation

  DURING A PROCEDURE, WHILE EXCHANGING ONE SHEATH FOR ANOTHER, THE PROXIMAL PART BECAME SEPARATED FROM THE SHEATH, REMAINING IN THE RIGHT FEMORAL VEIN. A SNARE WAS USED TO REMOVE FROM THE PATIENT. FLUOROSCOPY WAS USED TO CONFIRM ALL PIECES WERE ACCOUNTED FOR. THE DEVICE WAS EXCHANGED TO COMPLETE THE PROCEDURE. NO ADDITIONAL PUNCTURE SITE WAS NEEDED.

  Patient problems: Foreign Body In Patient

  MAUDE report 17976959 ↗
• InjuryOct 5, 2022Material Separation; Material Separation

  UPON REMOVAL OF THE INTRODUCER, A PORTION OF THE DEVICE DETACHED AND REMAINED IN THE PATIENT WHEN SUTURING THE INSERTION SITE. THE DETACHED PORTION OF SHEATH WAS NOTED ON FLUOROSCOPY. THE SITE WAS RE-ACCESSED TO ALLOW FOR SNARE INSERTION AND RETRIEVAL OF THE SHEATH PORTION WHICH HAD MIGRATED TOWARD THE RIGHT VENTRICULAR REGION. THE SNARE WAS USED TO RETRIEVE THE DETACHED PORTION WITH NO APPARENT INJURY TO THE PATIENT.

  Patient problems: Foreign Body In Patient

  MAUDE report 15542651 ↗
• MalfunctionSep 7, 2022Fracture; Material Frayed; Fracture; Material Frayed

  THIS REPORT IS TO ADVISE OF A INTRODUCER FRACTURE FOUND DURING ANALYSIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15373375 ↗
• MalfunctionJul 21, 2022Material Separation; Material Separation

  DURING A PULMONARY VEIN ISOLATION PROCEDURE FOR ATRIAL FIBRILLATION, THE SHEATH BROKE AND DETACHED DURING THE Z-SUTURE AND REMAINED IN THE GROIN. THE PATIENT WAS TRANSFERRED TO VASCULAR SURGERY WHERE THE DETACHED PORTION WAS REMOVED UNDER FLUOROSCOPY. PER THE SURGEON, THERE WERE NO FURTHER CONSEQUENCES TO THE PATIENT.

  Patient problems: Foreign Body In Patient

  MAUDE report 15074592 ↗
• MalfunctionJun 19, 2019Gas/Air Leak; Gas/Air Leak

  DURING A PROCEDURE AIR WAS NOTED TO LEAK FROM THE INTRODUCER HEMOSTASIS VALVE. THE SHEATH WAS REPLACED AND THE PROCEDURE WAS COMPLETED WITH NO ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8711294 ↗
• MalfunctionJun 18, 2019Fluid/Blood Leak; Fluid/Blood Leak

  DURING THE PROCEDURE, A BLOOD LEAK WAS NOTED IN THE SHEATH. ANOTHER SHEATH WAS USED TO CONTINUE THE PROCEDURE WITH NO CONSEQUENCES TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8707264 ↗
• MalfunctionMar 29, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  FOLLOWING AN ATRIAL FIBRILLATION PROCEDURE, THE DISTAL PORTION OF THE INTRODUCER DETACHED. UPON REMOVAL OF THE INTRODUCER, THE DISTAL PORTION OF THE DEVICE REMAINED IN THE PATIENT. THE DISTAL PORTION WAS REMOVED USING A PINCETTE WITH NO CONSEQUENCES TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8463521 ↗
• InjuryMar 6, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  VOLUNTARY MEDWATCH NUMBER: MW5082982. DURING AN ELECTIVE VENTRICULAR TACHYCARDIA PROCEDURE, THE DISTAL PORTION OF THE SHEATH DETACHED BELOW THE SKIN SURFACE. THE SHEATH WAS KINKED BEFORE INSERTING THE CATHETER. THE CATHETER WAS INSERTED BUT APPROACHED THE KINK. WHEN THE CATHETER WAS BEING REMOVED, THE DISTAL TIP OF THE INTRODUCER HAD DETACHED BELOW THE SURFACE OF THE SKIN. THE PROCEDURE WAS STOPPED AND THE INTRODUCER TIP REQUIRED SURGICAL INTERVENTION TO REMOVE. THE PATIENT WAS TRANSFERRED TO ANOTHER FACILITY FOR THE ABLATION PROCEDURE IN STABLE CONDITION.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 8396617 ↗