Impress® 00884450717950Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00884450717950), received between May 3, 2023 and May 3, 2023 — 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 18, 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 3, 2023Fracture; Material Separation; Fracture; Material Separation

  THE ACCOUNT ALLEGES THAT DURING A LEG ANGIOGRAM THE TIP OF THE CATHETER CAME OFF THE AND FELL OFF IN THE PATIENT'S ARTERY. THIS OCCURRED WHEN THE PHYSICIAN INSERTED THE CATHETER THROUGH THE SHEATH WITH A GLIDE WIRE ON THE RIGHT GROIN SIDE, OVER THE BIFURCATION AND DOWN INTO THE LEFT SFA. THE PHYSICIAN THEN WANTED TO SWITCH THE WIRE OUT AND WHEN HE PULLED BACK THE WIRE, THE TIP OF THE CATHETER BECAME DISLODGED AND WAS FLOATING IN THE SFA. HE WAS ABLE TO SNARE THE BROKEN PIECE OUT OF THE PATIENT AND ON THE BLACK PORTION OF THE CATHETER THEY OBSERVED A KINK. THERE WAS NO HARM TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16860440 ↗