Impress® 00884450687567Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00884450687567), received between Jan 30, 2024 and Jul 24, 2024 — classified as 2 injuries.

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.

• InjuryJul 24, 2024Fracture; Fracture

  THE ACCOUNT ALLEGES THAT DURING AN ARTERIOVENOUS FISTULA ANGIOGRAPHY THE CATHETER BROKE DISTALLY INTO 2 PIECES. THE SURGEON DID NOT FORCE THE PROBE OR FLEXIBLE TERUM GUIDE. ONE PIECE COULD BE RECOVERED AND THE SECOND REMAINED STUCK IN THE PATIENT'S ARM.

  Patient problems: Foreign Body In Patient

  MAUDE report 19816798 ↗
• InjuryJan 30, 2024Fracture; Material Separation; Fracture; Material Separation

  THE ACCOUNT ALLEGES THAT DURING AN AO RUN-OFF PROCEDURE IN RADIOLOGY DEPARTMENT, THE CATHETER TIP DETACHED WITHIN THE PATIENT. THE PHYSICIAN HAD ACQUIRED RETROGRADE RIGHT FEMORAL ARTERY ACCESS AND HAD NEGOTIATED THE PATIENT'S ILIO-FEMORAL CONDUIT PLACING A STIFF SUPRA CORE .035 GUIDE WIRE AND THE 4F PIGTAIL CATHETER JUST INFERIOR TO THE RENAL ARTERIES WITHIN THE AO FOR IMAGING AND MASKING OF THE BILATERAL ARTERIAL CONDUIT OF THE PATIENT'S LOWER PERIPHERY. WHILE ATTEMPTING TO REMOVE THE CATHETER OVER THE GUIDEWIRE, A QUICK TUG WAS EXECUTED BY THE PHYSICIAN. THIS IS WHEN THE TIP DETACHED BUT REMAINED ON THE GUIDEWIRE WITHIN A CALCIFIED AND DISEASED COMMON ILIAC ARTERY. THE FOREIGN BODY WAS PULLED BACK TO THE PRIMARY ACCESS SITE ALONG WITH THE ACCESS GUIDEWIRE. DUE TO THE POSSIBLE IFB MIGRATION, A SECONDARY ACCESS POINT FROM THE LEFT FEMORAL ARTERY WAS SUCCESSFULLY ACQUIRED. THE PHYSICIAN USED A VASCULAR SNARE DEVICE TO SUCCESSFULLY EXTERNALIZE THE FOREIGN BODY FROM THE PATIENT'S SECONDARY ACCESS SITE, LIBERATING THE VESSEL. THE PATIENT TOLERATED THE PROCEDURE WELL WITH NO ADDITIONAL CONSEQUENCES TO REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18607560 ↗