Impress® 00884450646595Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00884450646595), received between Mar 15, 2023 and Sep 4, 2023 — classified as 2 injuries.

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

• InjurySep 4, 2023Fracture; Material Separation; Fracture; Material Separation

  THE ACCOUNT ALLEGES THAT DURING A PERCUTANEOUS NEPHROLITHOTOMY PROCEDURE, THE TIP OF THE CATHETER DETACHED. THE TIP WAS RETRIEVED FROM THE PATIENT VIA A SMALL BALLOON AND THE PROCEDURE WAS COMPLETED USING A DIFFERENT CATHETER. NO ADDITIONAL PATIENT CONSEQUENCES TO REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17680501 ↗
• InjuryMar 15, 2023Fracture; Material Separation; Fracture; Material Separation

  THE ACCOUNT ALLEGES THAT DURING A PROCEDURE THE CLINICIAN NOTED THE GUIDEWIRE PROTRUDING FROM THE CATHETER. ATTEMPTED REMOVAL OF THE WIRE FROM THE CATHETER RESULTED IN THE TIP OF THE CATHETER DETACHING WITHIN THE PATIENT. THE TIP WAS SUCCESSFULLY RETRIEVED FROM THE PATIENT. NO ADDITIONAL PATIENT CONSEQUENCES TO REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16549610 ↗