Impress® 00884450009109Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00884450009109), received between Jul 20, 2022 and Jul 20, 2022 — 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.

• InjuryJul 20, 2022Fracture; Material Separation; Fracture; Material Separation

  THE ACCOUNT ALLEGES THAT DURING A PERIPHERAL VASCULAR INTERVENTIONAL PROCEDURE, THE CATHETER TIP DETACHED WITHIN THE PATIENT. THE PHYSICIAN HAD ACQUIRED RETROGRADE ARTERIAL ACCESS AND HAD NEGOTIATED THE PATIENT'S ILIO-FEMORAL CONDUIT WITH A GUIDEWIRE AND THE 5F CATHETER UNDER FLUOROSCOPY. DURING CATHETER MANIPULATIONS OVER AN INTERVENTIONAL GUIDEWIRE, THE CATHETER TIP DETACHED. THE PHYSICIAN SUCCESSFULLY EXTERNALIZED PART OF THE FOREIGN BODY WITH A VASCULAR SNARE DEVICE. THE REMAINING FOREIGN BODY COULD NOT BE RETRIEVED. THE PHYSICIAN ALSO DEPLOYED SOME PERIPHERAL SCAFFOLDING TO SUCCESSFULLY PIN THE FOREIGN BODY WITHIN THE PATIENT'S ILIAC CONDUIT RESULTING IN NO ADDITIONAL CONSEQUENCES TO REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15070176 ↗