Impress® 00884450029558Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00884450029558), received between Apr 3, 2020 and Jan 27, 2022 — classified as 2 injuries, 1 malfunction.

The most frequently reported specific device problem is “Material Separation” (3 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 27, 2022Material Separation; Material Separation

  THE ACCOUNT ALLEGES THAT DURING A VASCULAR PROCEDURE INVOLVING A SNARE DEVICE, WHEN RETRIEVING THE VASCULAR SNARE FROM WITHIN THE CATHETER, THEY ALSO RETRIEVED SOME TYPE OF TRANSPARENT FOREIGN MATERIAL AS WELL. IT IS CURRENTLY UNKNOWN IF ANY OF THE FOREIGN MATERIAL HAD BEEN INADVERTENTLY INTRODUCED INTO THE PATIENT DURING USE. THE MATERIAL IN QUESTION IS NOT RADIOPAQUE. THE PATIENT WAS CLOSELY OBSERVED AND DISCHARGED AS EXPECTED WITH NO ADDITIONAL CONSEQUENCES TO REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13370313 ↗
• InjuryJan 27, 2022Fracture; Material Separation; Fracture; Material Separation

  THE ACCOUNT ALLEGES THAT DURING AN ENDOVASCULAR PROCEDURE, THE TIP OF THE 4F CATHETER DETACHED WITHIN THE PATIENT. THE PHYSICIAN USED A VASCULAR SNARE DEVICE TO EXTERNALIZE THE FOREIGN BODY LIBERATING THE VESSEL. NO ADDITIONAL PATIENT CONSEQUENCES TO REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13370296 ↗
• InjuryApr 3, 2020Fracture; Material Separation; Fracture; Material Separation

  THE ACCOUNT ALLEGES THAT DURING A PERIPHERAL VASCULAR INTERVENTION PROCEDURE, THE CATHETER TIP DETACHED WITHIN THE PATIENT. THE PHYSICIAN HAD ACQUIRED RETROGRADE FEMORAL ARTERY ACCESS AND HAD NEGOTIATED THE PATIENT'S COMMON ILIAC BIFURCATION WITH A GUIDEWIRE AND THE 4F 90CM DIAGNOSTIC CATHETER. DURING CATHETER MANIPULATIONS OVER THE WIRE, WITHIN THE PATIENT'S AORTIC BIFURCATION FROM A RIGHT TO LEFT ILIAC CROSS-OVER, RESISTANCE WAS EXPERIENCED, AND THE TIP DETACHED WITHIN THE COMMON ILIAC ARTERY. A CONTRALATERAL FEMORAL RETROGRADE PUNCTURE THAT WASN'T PLANNED WAS NEEDED TO RETRIEVE THE DETACHED TIP WITH A VASCULAR SNARE DEVICE. THE SECONDARY ACCESS SITE RESULTED IN A FALSE ANEURYSM WHICH MADE A SECONDARY PROCEDURAL INTERVENTION NECESSARY WITHIN THE SURGICAL ARENA UNDER GENERAL ANESTHESIA.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9920871 ↗