Impress® 00884450668771Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00884450668771), received between May 10, 2023 and Jun 4, 2024 — classified as 4 injuries.

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.

• InjuryJun 4, 2024Fracture; Fracture

  THE CUSTOMER REPORTS DURING AN AORTOGRAM THE CATHETER BROKE OFF IN AORTA ON A PATIENT. THE DEVICE WAS SUCCESSFULLY SNARED. THE ENTIRE BLACK TIP CAME OFF AS HE WAS PULLING CATHETER BACK OVER BIFURCATION. THERE WAS VESSEL TORTUOSITY, AND SOME CALCIFICATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19464358 ↗
• InjuryMay 30, 2023Fracture; Material Separation; Fracture; Material Separation

  THE ACCOUNT ALLEGES A LOWER LEG/SFA ARTERIAL ANGIOGRAM PROCEDURES, THE BLACK TIP OF THE CATHETER SEPARATED WITHIN THE PATIENT. TIP SEPARATION OCCURRED DURING [AO RUN-OFF] POWER INJECTIONS OF THE LOWER PERIPHERY. THE PHYSICIAN USED A RETRIEVAL BASKET TO SUCCESSFULLY LIBERATE THE FOREIGN BODIES FROM THE PATIENT'S VESSELS. NO ADDITIONAL INTERVENTIONS OR PATIENT CONSEQUENCES TO REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17027411 ↗
• InjuryMay 30, 2023Fracture; Material Separation; Fracture; Material Separation

  THE ACCOUNT ALLEGES A LOWER LEG/SFA ARTERIAL ANGIOGRAM PROCEDURES, THE BLACK TIP OF THE CATHETER SEPARATED WITHIN THE PATIENT. TIP SEPARATION OCCURRED DURING [AO RUN-OFF] POWER INJECTIONS OF THE LOWER PERIPHERY. THE PHYSICIAN USED A RETRIEVAL BASKET TO SUCCESSFULLY LIBERATE THE FOREIGN BODIES FROM THE PATIENT'S VESSELS. NO ADDITIONAL INTERVENTIONS OR PATIENT CONSEQUENCES TO REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17027368 ↗
• InjuryMay 10, 2023Fracture; Material Separation; Fracture; Material Separation

  MED WATCH RECEIVED MW5116899 - THE ACCOUNT ALLEGES THAT DURING A PERCUTANEOUS TRANSLUMINAL INTERVENTIONAL PROCEDURE, THE TIP OF THE 4F CATHETER TIP DETACHED DURING MANIPULATIONS, RESULTING IN A FREE-FLOATING FOREIGN BODY WITHIN THE AORTIC BIFURCATION. A SECONDARY ACCESS POINT WAS NECESSARY TO SUCCESSFULLY EXTERNALIZE THE FOREIGN BODY WITH A VASCULAR SNARE DEVICE LIBERATING THE VESSEL. NO ADDITIONAL PATIENT CONSEQUENCES TO REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16907342 ↗