Impress® 00884450295922Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00884450295922), received between Sep 24, 2018 and Sep 24, 2018 — classified as 1 injury.

The most frequently reported specific device problem is “Activation, Positioning or Separation Problem” (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.

• InjurySep 24, 2018Migration or Expulsion of Device; Activation, Positioning or Separation Problem

  PATIENT CAME TO HOSPITAL FOR A PROCEDURE TO COIL AN ENDOLEAK OF AN ENDOVASCULAR ABDOMINAL AORTIC ANEURYSM. THE PATIENT HAD FEMORAL ACCESS. THE SURGEON INTRODUCED THE VANSCHIE 5 CATHETER OVER A WIRE AND WAS POSITIONING THE CATHETER TO REACH THE LEAKING POINT. UNDER FLUOROSCOPY HE NOTICED THE WIRE WAS NOT OUT THE END OF THE CATHETER. HE PULLED CATHETER AND WIRE OUT OF THE PATIENT AND THE TIP OF THE CATHETER SAILED DOWNSTREAM AND RESTED ON THE SHEATH THAT WAS IN THE LEFT GROIN. THE PATIENT THEN REQUIRED GENERAL ANESTHESIA AND A FEMORAL CUTDOWN TO RETRIEVE THE CATHETER TIP. THE TIP WAS RETRIEVED. THE PATIENT REMAINED IN THE ICU FOR 48 HOURS FOR OBSERVATION. THE INTENDED PROCEDURE WAS ABORTED.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 7901397 ↗