Impress® 00884450023181Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00884450023181), received between Jul 1, 2020 and Sep 2, 2020 — classified as 1 injury, 1 malfunction.

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 16, 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.

• MalfunctionSep 2, 2020Fracture; Material Separation; Fracture; Material Separation

  THE ACCOUNT ALLEGES THAT DURING AN AORTIC [AAA] [EVAR] REPAIR THE TIP DETACHED. THE UNIT WAS USED FOR A STENT-GRAFT PROCEDURE. AFTER THE USE OF THE CATHETER, IT WAS PULLED OUT FROM THE PATIENT. HOWEVER, THE BLACK TIP IMMEDIATELY DETACHED AFTER WITHDRAWAL FROM THE PATIENT OUTSIDE THE BODY. NO FRAGMENT REMAINED IN THE PATIENT. NO PATIENT INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10483305 ↗
• InjuryJul 1, 2020Fracture; Material Separation; Fracture; Material Separation

  THE ACCOUNT ALLEGES THAT DURING AN INTERVENTIONAL PERIPHERAL VASCULAR PROCEDURE, THE CATHETER TIP DETACHED WITHIN THE PATIENT. THE PHYSICIAN HAD SUCCESSFULLY ACQUIRED LEFT RETROGRADE FEMORAL ARTERY ACCESS WITH THE 4F 100CM CATHETER. DURING CATHETER MANIPULATIONS UNDER FLUOROSCOPY, OVER A STIFF GUIDEWIRE AT THE PATIENT'S AORTIC BIFURCATION, THE CATHETER TIP DETACHED. SECONDARY ACCESS FROM THE PATIENT'S RIGHT FEMORAL ARTERY WITH A 6F SHEATH WAS ACQUIRED. THE PHYSICIAN WAS ABLE TO SUCCESSFULLY REMOVE THE FOREIGN BODY FROM THE PATIENT'S AORTIC BIFURCATION VIA THE RIGHT FEMORAL ARTERY WITH A VASCULAR SNARE DEVICE. NO ADDITIONAL CONSEQUENCES TO REPORT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10221202 ↗