Impress® 00884450020098Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00884450020098), received between May 12, 2021 and Feb 21, 2023 — classified as 3 injuries, 1 malfunction.

The most frequently reported specific device problem is “Fracture” (4 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 21, 2023Fracture; Material Separation; Fracture; Material Separation

  THE ACCOUNT ALLEGES THAT THE BLACK PORTION AT THE TIP OF THE CATHETER GOT DETACHED WITHIN THE VESSEL. AS THE TIP WAS ALONG A GUIDEWIRE, IT COULD BE SUCCESSFULLY WITHDRAWN OUT FROM THE VESSEL. NO FRAGMENT IS REMAINING IN THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16415038 ↗
• InjuryDec 20, 2022Fracture; Material Separation; Fracture; Material Separation

  THE ACCOUNT ALLEGES THAT WHILE USING THE ANGIOGRAPHY CATHETER, IT FRACTURED WITHIN THE PATIENT'S CAROTID ARTERY. THE PHYSICIAN CUT DOWN THE ARTERY TO REMOVE THE FOREIGN BODY.

  Patient problems: Foreign Body In Patient

  MAUDE report 16018634 ↗
• InjuryAug 9, 2022Fracture; Material Separation; Fracture; Material Separation

  THE ACCOUNT ALLEGES THAT DURING A SELECTIVE PERIPHERAL ANGIOGRAM PROCEDURE, THE CATHETER TIP DETACHED WITHIN THE PATIENT'S SUPERFICIAL FEMORAL ARTERY [SFA]. THE PHYSICIAN HAD ACQUIRED RETROGRADE FEMORAL ARTERY ACCESS AND HAD NEGOTIATED THE PATIENT ILIAC BIFURCATION TO ACCESS THE PATIENTS CONTRALATERAL SFA. WHILE MANIPULATING THE GUIDE CATHETER OVER AN INTERVENTIONAL GUIDEWIRE, UNDER FLUOROSCOPY, THE CATHETER TIP DETACHED WITHIN THE PATIENTS SFA. SOME VASCULAR CALCIFICATION WAS APPRECIATED. THE PHYSICIAN USED A VASCULAR SNARE DEVICE TO SUCCESSFULLY EXTERNALIZE THE FOREIGN BODY LIBERATING THE VESSEL. NO ADDITIONAL PATIENT CONSEQUENCES TO REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15196295 ↗
• InjuryMay 12, 2021Fracture; Material Separation; Fracture; Material Separation

  THE ACCOUNT ALLEGES THAT DURING A PERIPHERAL VASCULAR PROCEDURE, THE CATHETER TIP DETACHED WITHIN THE PATIENT. THE PHYSICIAN HAD SUCCESSFULLY ACQUIRED RETROGRADE ARTERIAL ACCESS AND DURING CATHETER MANIPULATIONS WITHIN THE VASCULATURE, OVER A GUIDE WIRE, UNDER FLUOROSCOPY THE CATHETER TIP DETACHED. THE FOREIGN BODY WAS SUCCESSFULLY RETRIEVED FORM THE PATIENT WITH VASCULAR SNARE DEVICES. A NEW CATHETER WAS USED TO COMPLETE THE PROCEDURE FOR THE PATIENT. NO ADDITIONAL CONSEQUENCES TO REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11813232 ↗