Fast-Cath™ 406128Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 05414734008280), received between Oct 23, 2018 and Jan 22, 2025 — classified as 1 injury, 4 malfunctions.

The most frequently reported specific device problem is “Material Puncture/Hole” (2 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 22, 2025Difficult to Remove; Difficult to Remove

  DURING CARDIOMEMS IMPLANT PROCEDURE, THE PHYSICIAN WAS UNABLE TO REMOVE THE SHEATH WHICH CAUSED A DELAY. THE PHYSICIAN COULD NOT SEPARATE THE SHEATH, WIRE, AND CARDIOMEMS DEVICES FROM EACH OTHER. DURING THE CARDIOMEMS IMPLANT, THE WIRE DID NOT HAVE THE SUPPORT TO BRING THE CARDIOMEMS SENSOR TO THE PULMONARY ARTERY. THE PHYSICIAN TRIED TO PULL THE DEVICE BACK THROUGH THE SHEATH, BUT IT FOLDED ONTO ITSELF. THE PHYSICIAN DETERMINED THAT THE SHEATH AND DEVICE COULD NOT BE SAFELY REMOVED. A SIGNIFICANT DELAY WAS REPORTED WHILE THE PHYSICIAN WAS DECIDING AN ACTION PLAN AND WAITING FOR VASCULAR SURGERY TO ARRIVE. VASCULAR SURGERY WAS CALLED AND THEY WERE ABLE TO PULL THE SHEATH OUT, BUT THE CMEMS DEVICE REMAINED IN THE SOFT TISSUE. VASCULAR SURGERY WAS ABLE TO DO A SMALL CUT DOWN AND REMOVED THE CARDIOMEMS DEVICE. THE PATIENT HAD A PERCLOSE IN PLACE AND THAT WAS UTILIZED. PATIENT REMAINED STABLE THROUGHOUT THE ENTIRE PROCEDURE. THE PATIENT REMAINED STABLE THROUGHOUT THE ENTIRE PROCEDURE. THE PATIENT WAS DISCHARGED AND NOT HOSPITALIZED FOLLOWING THE PROCEDURE. THERE WERE NO POST-PROCEDURE COMPLICATIONS, BUT THE PHYSICIAN REPORTED THERE TO BE A SIGNIFICANT DELAY DUE TO DECIDING THE PLAN OF

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21211058 ↗
• MalfunctionJun 13, 2024Material Puncture/Hole; Material Puncture/Hole

  AT THE END OF A SUCCESSFUL IMPLANT PROCEDURE, IT WAS REPORTED THAT WHEN THE INTRODUCER WAS REMOVED FROM THE PATIENT, A HOLE WAS OBSERVED NEAR THE END OF THE SHEATH. THE PROCEDURE HAD GONE FINE AND WITH NO ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19528302 ↗
• MalfunctionFeb 28, 2023Material Puncture/Hole; Material Puncture/Hole

  DURING THE RIGHT HEART CATHETERIZATION PROCEDURE, THE SHEATH WENT IN SMOOTH ON INSERTION, HOWEVER, AFTER REMOVAL FROM THE PATIENT, THE SHEATH WAS NOTED TO BE KINKED AND PUNCTURED. THE INTRODUCER WAS NOT EXCHANGED AND THE PROCEDURE WAS COMPLETED WITH NO ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16453678 ↗
• MalfunctionDec 12, 2019Fluid/Blood Leak; Fluid/Blood Leak

  WHILE USING THE INTRODUCER, THERE WAS BLOOD LEAKING FROM THE DEVICE AFTER THE DILATOR WAS INSERTED. THE SHEATH WAS REPLACED AND THE PROCEDURE WAS COMPLETED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9457394 ↗
• InjuryOct 23, 2018Material Separation; Material Separation

  DURING A PROCEDURE THE INTRODUCER WAS BEING USED TO INSERT AND ADVANCE THE CARDIOMEMS DELIVERY CATHETER SYSTEM. AT THE END OF A PROCEDURE, UPON REMOVAL OF THE SHEATH FROM THE PATIENT'S RIGHT FEMORAL VEIN, THE DISTAL PORTION OF THE SHEATH REMAINED IN THE VESSEL WHILE THE PROXIMAL PORTION WAS RETRACTED AND REMOVED. A SNARE WAS USED TO REMOVE THE REMAINDER OF THE DEVICE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 7995642 ↗