Impress® 00884450042564Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00884450042564), received between May 10, 2023 and May 10, 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 18, 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.

• InjuryMay 10, 2023Fracture; Material Separation; Fracture; Material Separation

  THE PHYSICIAN ALLEGES THAT DURING A DIAGNOSTIC CONTRAST MEDIUM INJECTION ON AN INFANT PATIENT, THE PHYSICIAN NOTICED THE CATHETER WAS LEAKING FLUID AT THE HUB. THE PHYSICIAN EXCHANGED THE CATHETER FOR A NEW ONE, BUT UPON ENTRY OF THE SECOND CATHETER, THE CATHETER DETACHED WITHIN THE PATIENT. THE PHYSICIAN SUCCESSFULLY EXTERNALIZED THE FOREIGN BODY WITH A VASCULAR SNARE DEVICE LIBERATING THE VESSEL. NO ADDITIONAL PATIENT CONSEQUENCES TO REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16907341 ↗
• InjuryMay 10, 2023Fracture; Material Separation; Fracture; Material Separation

  THE ACCOUNT ALLEGES THAT DURING AN AV FISTULAGRAM THROMBECTOMY ON (B)(6) 2023, THE TIP OF THE CATHETER DETACHED WITHIN THE PATIENT'S FISTULA. THE SURGEON USED A VASCULAR SNARE DEVICE TO SUCCESSFULLY EXTERNALIZE THE FOREIGN BODY LIBERATING THE FISTULA. THE PATIENT TOLERATED THE PROCEDURE WELL, NO ADDITIONAL CONSEQUENCES TO REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16907340 ↗