Fast-Cath™ 406804Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 05414734203302), received between Dec 27, 2018 and May 23, 2022 — classified as 1 injury, 6 malfunctions.

The most frequently reported specific device problem is “Material Puncture/Hole” (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. How this data works · Data updated Oct 13, 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.

• MalfunctionMay 23, 2022Material Puncture/Hole; Material Puncture/Hole

  DURING AN ATRIAL FIBRILLATION ABLATION PROCEDURE, WHILE INSERTING DILATOR INTO INTRODUCER, DILATOR HAD PUNCTURED THE INTRODUCER AT THE SHEATH TIP. A NEW DEVICE WAS USED TO CONTINUE THE PROCEDURE WITH NO ADVERSE PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14475852 ↗
• MalfunctionApr 5, 2022Fluid/Blood Leak; Fluid/Blood Leak

  DURING THE PROCEDURE, A FLUID LEAK WAS NOTED AT THE LEVEL OF THE NON-RETURN VALVE OF THE SHEATH RESULTING IN A LIQUID ENTRY INTO THE STEREOTAXIS SYSTEMR. THE PROCEDURE CONTINUED WITH NO CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14016016 ↗
• MalfunctionOct 4, 2021Material Puncture/Hole; Material Puncture/Hole

  DURING AN ATRIAL FIBRILLATION PROCEDURE, THE SHEATH BECAME PUNCTURED. THE DEVICE WAS REPLACED AND THE PROCEDURE WAS COMPLETED WITH NO ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12569091 ↗
• MalfunctionMar 9, 2021Material Protrusion/Extrusion

  DILATOR SHEATH "POKING" THROUGH SHEATH, DID NOT ENTER THE PATIENT'S BODY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11444265 ↗
• MalfunctionAug 21, 2020Material Deformation

  INCIDENT DESCRIPTION: PRODUCT NEVER WENT IN PATIENT. THE SHEATH WAS FLUSHED AND WHILE ADVANCING THE DILATOR CARDIOVASCULAR TECHNOLOGIST (CVT) NOTED THE DILATOR WAS DEFORMING THE CURVE AND POKING THROUGH THE BACK-END. REPLACED WITH ANOTHER OF SAME. ZERO PROBLEM ADVANCING THE DILATOR. NOTES FROM THE EP PROCEDURE: THREE SHEATHS WERE INSERTED INTO THE RIGHT FEMORAL VEIN (RFV) (9,8,7FR) USING ULTRASOUND GUIDANCE. AN 8FR INTRACARDIAC ECHOCARDIOGRAPHY CATHETER WAS INSERTED AND ADVANCED INTO THE RIGHT ATRIUM. INTRACARDIAC ECHOCARDIOGRAPHY WAS PERFORMED WHICH REVEALED NORMAL LV FUNCTION AND NO BASELINE PERICARDIAL EFFUSION AND WAS LATER USED TO GUIDE THE TRANSSEPTAL PUNCTURE. NOTABLY THE CAVOTRICUSPID ISTHMUS (CTI) ANATOMY WAS VERY CURVILINEAR WITH A BIG POUCH. A DECAPOLAR DIAGNOSTIC CATHETER WAS ADVANCED TO THE CORONARY SINUS FOR LEFT ATRIAL PACING AND RECORDING. THE CS WAS ENGAGED BUT THERE WAS A PROMINENT VALVE OF VIEUSSENS AND SO A 4FR INQUIRY WAS TRIED. THIS TOO WAS UNSUCCESSFUL. AN 8.5FR MULLENS SHEATH WAS USED FOR SUPPORT AND WITH THE ORIGINAL BOS SCI DECAPOLAR THROUGH THE MULLENS THE VALVE OR FENESTRATION WAS CROSSED. CATHETERS/WIRES WERE ADVANCED TO THE HEART UNDER FLUOROSCOPIC GUI

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10436023 ↗
• InjuryFeb 5, 2019Material Puncture/Hole; Material Puncture/Hole

  DURING A PROCEDURE THE NEEDLE PERFORATED THE SIDE OF THE SHEATH WHEN BEING INSERTED. 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 8304860 ↗
• MalfunctionDec 27, 2018Flaked; Flaked

  DURING TRANSSEPTAL PUNCTURE, RESISTANCE WAS NOTED WHEN THE NEEDLE, WITHOUT THE STYLET, WAS ADVANCED THROUGH THE SHEATH. THE NEEDLE WAS REMOVED AND A SMALL PIECE OF PLASTIC WAS NOTED ON THE NEEDLE. A NEW NEEDLE AND SHEATH WERE USED TO COMPLETE THE PROCEDURE WITH NO CONSEQUENCES TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8199328 ↗