Impress® 00884450009321Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00884450009321), received between May 14, 2020 and May 14, 2020 — classified as 1 injury.

The most frequently reported specific device problem is “Fracture” (1 report).

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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryMay 14, 2020Fracture; Material Separation; Fracture; Material Separation

  THE ACCOUNT ALLEGES THAT DURING A PERIPHERAL PERCUTANEOUS TRANSLUMINAL REVASCULARIZATION PROCEDURE, THE CATHETER TIP DETACHED WITHIN THE PATIENT. THE CLINICIAN HAD ACQUIRED RIGHT RETROGRADE ARTERIAL ACCESS AND HAD NEGOTIATED THE PATIENT'S RIGHT COMMON ILIAC BIFURCATION WITH A GUIDEWIRE AND 5F CATHETER. DURING CATHETER MANIPULATIONS WITHIN THE RIGHT COMMON ILIAC ARTERY, THE CATHETER TIP DETACHED. THE PHYSICIAN USED A VASCULAR SNARE DEVICE TO SUCCESSFULLY RETRIEVE THE FOREIGN BODY FROM THE PATIENT. THE REVASCULARIZATION PROCEDURE WAS RE-SCHEDULED DUE TO EXTENSIVE RADIATION EXPOSURE AND DELAY IN PROCEDURE DUE TO THE ADDITIONAL [FOREIGN BODY RETRIEVAL] PROCEDURE. THE PATIENT TOLERATED THE PROCEDURE WELL AND RESCHEDULED FOR REVASCULARIZATION OF THE LEFT LOWER LIMB.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10059724 ↗