Impress® 00884450043769Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00884450043769), received between Apr 4, 2023 and May 23, 2023 — classified as 2 injuries.

The most frequently reported specific device problem is “Material Separation” (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.

• InjuryMay 23, 2023Break; Material Separation; Break; Material Separation

  THE ACCOUNT ALLEGES THAT DURING A SURGICAL ABDOMINAL AORTIC STENT IMPLANT PROCEDURE [AAA] ON A FEMALE PATIENT, THE PROXIMAL HYDROPHILIC SEGMENT OF THE 5F CATHETER DETACHED WITHIN THE PATIENT. THE PHYSICIAN HAD ACQUIRED RETROGRADE FEMORAL ARTERY ACCESS TO DELIVER A COIL-TYPE EMBOLIC DEVICES, DURING CATHETER MANIPULATIONS OVER A GUIDEWIRE UNDER FLUOROSCOPY, THE CATHETER TIP DETACHED WITHIN THE PATIENT'S COMMON ILIAC ARTERY. THE PHYSICIAN USED A VASCULAR SNARE DEVICE TO SUCCESSFULLY EXTERNALIZE THE FRAGMENTED FOREIGN BODIES, BUT THE FOREIGN BODY AGAIN WAS FRAGMENTED. A THROMBECTOMY CATHETER WAS EVENTUALLY USED TO REMOVE ALL FRAGMENTED PARTS LIBERATING THE PATIENT'S VESSEL. NO ADDITIONAL PATIENT CONSEQUENCES TO REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16986522 ↗
• InjuryApr 4, 2023Fracture; Material Separation; Fracture; Material Separation

  THE ACCOUNT ALLEGES THAT AT THE BEGINNING OF THE PROCEDURE, THE DOCTOR REQUESTED A PUNCTURE NEEDLE AND 5F INTRODUCER, LATER HE REQUESTED A HYDROPHILIC GUIDEWIRE AND A 5F CATHETER. AS IT WAS A FIBROID EMBOLIZATION, THE DOCTOR SUGGESTED USING A UAC CATHETER, BUT HE REJECTED IT. AFTER INTRODUCING THE 5F CATHETER INTO THE PATIENT, DURING ITS MANIPULATION BY THE DOCTOR, THE HYDROPHILIC TIP DISLODGED, THE DOCTOR REMOVED IT WITH AN ENDOVASCULAR LOOP, THE DOCTOR MANAGED TO REMOVE THE FRAGMENTS LODGED INSIDE THE PATIENT AND THE INTERVENTION ENDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16675233 ↗