Impress® 00884450661529Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00884450661529), received between May 21, 2025 and Aug 27, 2025 — classified as 2 injuries, 1 malfunction.

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.

• InjuryAug 27, 2025Break; Fracture; Material Integrity Problem; Break; Fracture; Material Integrity Problem

  THE ACCOUNT ALLEGES THAT DURING A UTERINE FIBROID EMBOLIZATION PROCEDURE, WHILE PERFORMING SELECTIVE CATHETERIZATION OF THE INTERNAL BRANCH OF THE RIGHT UTERINE ARTERY, THE DISTAL PART OF THE CATHETER DETACHED. THE DISTAL FRAGMENT THEN MIGRATED TOWARD THE FEMORAL SEGMENT, MAKING IT NECESSARY TO PERFORM ARTERIAL DISSECTION TO REMOVE THE FOREIGN BODY. ENDOVASCULAR REMOVAL WITH THE DEVICE IN A LOOP WAS NOT POSSIBLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22909976 ↗
• MalfunctionJul 16, 2025Break; Fracture; Break; Fracture

  THE ACCOUNT ALLEGES THAT THE CATHETER WAS BROKEN PRIOR TO OPENING THE PACKAGE. NO PATIENT HARM OR INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22522717 ↗
• InjuryMay 21, 2025Fracture; Fracture

  THE ACCOUNT ALLEGES THE BLACK TIP PORTION OF THE CATHETER CAME APART FROM THE PURPLE CATHETER BODY IN A PATIENT. THE PORTION THAT BROKE OFF WAS ABLE TO BE RETRIEVED FROM THE PATIENT.

  Patient problems: Foreign Body In Patient

  MAUDE report 22061189 ↗