Impress® 00884450038192Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00884450038192), received between May 30, 2023 and Jul 29, 2025 — classified as 3 injuries.

The most frequently reported specific device problem is “Fracture” (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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryJul 29, 2025Fracture; Material Separation; Fracture; Material Separation

  THE ACCOUNT ALLEGES FOR BLEEDING IN THE RIGHT ILIAC A CATHETER WAS USED IN THE LEFT FEMORAL VIA A 6F INTRODUCER. ONCE THE CATHETER WAS IN THE PATIENT A SMALL PART OF THE TIP CAME OFF THE CATHETER. AN ATTEMPT TO REMOVE THE TIP WITH A SNARE WAS UNSUCCESSFUL AND TIP REMAINED IN THE PATIENT. A SECOND DEVICE FROM THE SAME LOT WAS OPENED. THIS TIME THE ENTIRE TIP DETACHED IN THE PATIENT. DURING A REMOVAL ATTEMPT THE TIP FRAGMENTED AND ONLY SMALL AMOUNTS OF THE TIP WERE ABLE TO BE REMOVED. SMALLER PIECES OF THE TIP REMAINED IN THE PATIENT. A DIFFERENT CATHETER WAS USED TO COMPLETE THE PROCEDURE.

  Patient problems: Foreign Body In Patient

  MAUDE report 22660712 ↗
• InjuryJul 29, 2025Fracture; Material Separation; Fracture; Material Separation

  THE ACCOUNT ALLEGES THAT A VASCULAR SURGEON WAS PERFORMING A LEG ANGIOGRAM; WHILE REMOVING THE CATHETER FROM THE FEMORAL ARTERY, THE TIP OF THE CATHETER BROKE OFF. A SNARE DEVICE WAS USED TO RETRIEVE AND REMOVE THE CATHETER TIP FROM THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22660600 ↗
• InjuryMay 30, 2023Fracture; Material Separation; Fracture; Material Separation

  THE ACCOUNT ALLEGES THAT DURING A TACE PROCEDURE, THE CATHETER FRACTURED AND LODGED IN THE LEFT FEMORAL ARTERY. THE PHYSICIAN ATTEMPTED TO SNARE THE FRAGMENT OUT WITH A SNARE, BUT THE FRAGMENT FRACTURED FURTHER. PROVIDER PLANS TO PERFORM A THROMBECTOMY PROCEDURE TO REMOVE THE FOUR FRAGMENTS.

  Patient problems: Foreign Body In Patient

  MAUDE report 17027369 ↗