Fast-Cath™ 406114Recalls & reported problems

Summary

The FDA's MAUDE database contains 18 adverse event reports that list this exact device (DI 05414734013932), received between Dec 3, 2018 and Mar 3, 2025 — classified as 2 injuries, 16 malfunctions.

The most frequently reported specific device problem is “Material Separation” (16 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 18 most recent of 18 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 3, 2025Material Separation; Material Separation

  THIS REPORT IS TO ADVISE OF A SIDEPORT DETACHMENT THAT OCCURRED DURING TESTING OF RETURNED UNUSED STERILE DEVICES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21504611 ↗
• InjuryFeb 26, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT FOLLOWING A TRANSCATHETER AORTIC VALVE REPLACEMENT (TAVR) PROCEDURE THAT INCLUDED TEMPORARY TRANSVENOUS PACING (TVP) VIA RIGHT FEMORAL VEIN, THE TVP DISLODGED. CODE BLUE WAS CALLED BUT NO COMPRESSIONS WERE DONE. A TVP WAS PLACED VIA RIGHT IJ (INTERNAL JUGULAR) VEIN AT BEDSIDE BUT DISLODGED AGAIN. THE PATIENT WAS EMERGENTLY TRANSFERRED TO THE CATH LAB FOR TVP. IT WAS NOTED THAT THE SIDEPORT OF THE SHEATH CAME OUT WHICH RESULTED IN BLEEDING.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 21471442 ↗
• MalfunctionFeb 11, 2025Material Separation; Material Separation

  DURING A PROCEDURE, AFTER INSERTION IN THE PATIENT, THE SIDE PORT DISCONNECTED FROM THE SHEATH CAUSING MINOR BLEEDING WITH NO INTERVENTION REQUIRED. THERE WERE NO ADVERSE PATIENT CONSEQUENCES.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; No Clinical Signs, Symptoms or Conditions

  MAUDE report 21361274 ↗
• MalfunctionFeb 11, 2025Material Separation; Material Separation

  DURING A PROCEDURE, AFTER INSERTION IN THE PATIENT, THE SIDE PORT DISCONNECTED FROM THE SHEATH CAUSING MINOR BLEEDING WITH NO INTERVENTION REQUIRED. THERE WERE NO ADVERSE PATIENT CONSEQUENCES.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; No Clinical Signs, Symptoms or Conditions

  MAUDE report 21361271 ↗
• MalfunctionDec 6, 2024Material Separation; Material Separation

  DURING A HEART CATHETERIZATION, THE INTRODUCER WAS PLACED IN THE PATIENT'S RIGHT INTERNAL JUGULAR VEIN. TWO DAYS POST PROCEDURE, THE PATIENT COMPLAINED OF LEAKING IV FLUIDS FROM THE SITE. THE NURSE FOUND THAT THE SIDE-PORT OF THE INTRODUCER WAS NO LONGER ATTACHED AND BLEEDING WAS NOTED FROM OUTLET HOLE. THE SITE WAS COVERED AND THE INTRODUCER WAS REMOVED WITH NO HARM TO THE PATIENT.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; No Clinical Signs, Symptoms or Conditions

  MAUDE report 20865779 ↗
• MalfunctionNov 19, 2024Material Separation; Material Separation

  THIS REPORT INCLUDES AN UPDATED HEALTH IMPACT CODE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20723324 ↗
• MalfunctionNov 8, 2024Material Separation; Material Separation

  DURING A HEART CATHETERIZATION, THE SHEATH WAS PLACED IN THE RIGHT INTERNAL JUGULAR VEIN. TWO DAYS POST PROCEDURE, THE PATIENT COMPLAINED OF LEAKING IV FLUIDS FROM THE SITE. IT WAS FOUND THAT A PORTION OF THE INTRODUCER WAS NO LONGER ATTACHED AND BLEEDING WAS NOTED FROM THE OUTLET HOLE. THE SITE WAS COVERED AND THE CATHETER AND INTRODUCER WERE REMOVED FROM THE PATIENT.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; No Clinical Signs, Symptoms or Conditions

  MAUDE report 20645597 ↗
• MalfunctionOct 30, 2024Material Separation; Material Separation

  DURING A RIGHT HEART PASS USING THE INTERNAL JUGULAR VEIN, A SIDE-PORT DETACHMENT OCCURRED. 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 20570490 ↗
• MalfunctionOct 30, 2024Material Separation; Material Separation

  DURING A RIGHT HEART PASS USING THE INTERNAL JUGULAR VEIN, A SIDE-PORT DETACHMENT OCCURRED. 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 20570375 ↗
• MalfunctionOct 29, 2024Material Separation; Material Separation

  DURING A PROCEDURE, THE SIDE PORT OF THE SHEATH DETACHED. THERE IS NO ADDITIONAL INFORMATION AVAILABLE AT THIS TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20561701 ↗
• MalfunctionOct 29, 2024Material Separation; Material Separation

  FOLLOWING A PROCEDURE, THE SIDE PORT OF THE SHEATH DETACHED. THERE WERE NO ADVERSE PATIENT CONSEQUENCES. THERE IS NO FURTHER INFORMATION AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20561679 ↗
• MalfunctionOct 23, 2024Material Separation; Material Separation

  RELATED MANUFACTURING REF: 3005334138-2024-00446, 3005334138-2024-00447. DURING THE PROCEDURE IT WAS NOTED THAT THE SIDE PORT OF THREE INTRODUCERS CAME LOOSE. TWO OF THE THREE INTRODUCERS WERE IN THE PATIENT. A FOURTH WAS USED TO COMPLETE THE PROCEDURE WITH NO ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20515422 ↗
• MalfunctionOct 15, 2024Material Separation; Material Separation

  FOLLOWING THE PROCEDURE, WHILE IN THE CCU, THE PATIENT FELT SOMETHING ¿WET¿ ON THEIR NECK AT THE DRESSING SITE. UPON INVESTIGATION IT WAS NOTED THAT THE SIDEPORT OF THE SHEATH HAD BROKEN OFF AND HAD TO BE REPLACED.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; No Clinical Signs, Symptoms or Conditions

  MAUDE report 20455303 ↗
• MalfunctionOct 15, 2024Material Separation; Material Separation

  THE INTRODUCER DETACHED AT THE SIDEPORT, WHERE PA CATHETER WAS INSERTED THROUGH. NO ADDITIONAL INFORMATION IS AVAILABLE. DATE OF EVENT WAS SEPTEMBER OF 2024.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; No Clinical Signs, Symptoms or Conditions

  MAUDE report 20451780 ↗
• MalfunctionJul 2, 2024Material Separation; Material Separation

  WHILE DISCONTINUING THE NON-ABBOTT CATHETER (SWAN GANZ CATHETER BY EDWARDS LIFESCIENCES) AND SHEATH, IT WAS OBSERVED THAT THE SIDEPORT WAS DISCONNECTED. SINCE THE PLAN WAS FOR THERAPY TO BE DISCONTINUED, NO CHANGES OR INTERVENTIONS WERE NEEDED AS A RESULT OF THE DETACHMENT. THERE WERE NO REPORTED ADVERSE CONSEQUENCES FOR THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19658060 ↗
• MalfunctionJul 2, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT WHILE THE NURSE WAS PREPARING TO PULL THE NON-ABBOTT CATHETER (SWAN GANZ CATHETER BY EDWARDS LIFESCIENCES), IT WAS OBSERVED THAT THE SIDEPORT DISCONNECTED. THE ORIGINAL TREATMENT PLAN WAS TO PULL THE NON-ABBOTT CATHETER (SWAN GANZ CATHETER) AND LEAVE THE SHEATH IN PLACE TO USE AS AN INFUSION PORT BUT DUE TO THE DETACHMENT, THE SHEATH NEEDED TO BE DISCONTINUED AS WELL. THERE WERE NO REPORTED ADVERSE CONSEQUENCES FOR THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19658046 ↗
• MalfunctionDec 12, 2019Material Puncture/Hole; Material Puncture/Hole

  DURING THE PROCEDURE, A HOLE WAS NOTICED IN THE SHEATH. THE PROCEDURE WAS COMPLETED USING THE SWAN-GANZ FOR CATHETER INSERTION TO CONTINUE ABLATION WITH NO ADVERSE PATIENT CONSEQUENCES.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9458572 ↗
• InjuryDec 3, 2018Gas/Air Leak; Gas/Air Leak

  DURING AN IABP (INTRAAORTIC BALLOON PUMP) PROCEDURE, AN AIR LEAK WAS NOTED. FOLLOWING INSERTION INTO THE PATIENT, AIR WAS ASPIRATED INTO THE SYRINGE CONNECTED TO THE EXTENSION PORT OF THE SHEATH. SEVERAL ASPIRATIONS WERE ATTEMPTED WITH NO RESOLUTION. THE SHEATH SET WAS REPLACED AND THE PROCEDURE WAS COMPLETED WITH NO ADVERSE CONSEQUENCES TO THE PATIENT. PATIENT'S INFORMATION (E.G. AGE, WEIGHT, GENDER, ETHNICITY, RACE, PATIENT'S INITIALS) CANNOT BE HANDLED BY ABBOTT IN ABSENCE OF PATIENT'S WRITTEN CONSENT AS REQUIRED BY THE PERSONAL DATA PROTECTION NATIONAL LEGISLATION. NATIONAL LEGISLATION PREVENTS THE RECORDING OF SUCH INFORMATION. A WRITTEN CONSENT HAS NOT BEEN OBTAINED IN THIS CASE; THEREFORE, THIS INFORMATION IS NOT AVAILABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8126302 ↗