Impress® 00884450038093Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00884450038093), received between Oct 31, 2023 and Jun 25, 2024 — classified as 5 injuries.

The most frequently reported specific device problem is “Fracture” (5 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryJun 25, 2024Fracture; Material Separation; Fracture; Material Separation

  THE ACCOUNT ALLEGES THAT DURING THE USE OF THE UAC CATHETER, THE BLACK HYDROPHILIC PORTION OF THE DEVICE DISCONNECTED FROM THE REST OF THE CATHETER. AN ATTEMPT WAS MADE TO REMOVE IT WITH A SNARE, BUT THE DISCONNECTED PART FRAGMENTED FURTHER. THE FRAGMENTS BECAME LODGED WITHIN THE RIGHT HYPOGASTRIC AND RIGHT POPLITEAL ARTERIES. NO ADDITIONAL INFORMATION AVAILABLE.

  Patient problems: Foreign Body In Patient

  MAUDE report 19605870 ↗
• InjuryFeb 19, 2024Fracture; Material Separation; Fracture; Material Separation

  THE ACCOUNT ALLEGES THAT DURING THE BENDING MANEUVER IN THE AORTA FOR CONTRALATERAL CATHETERIZATION OF THE LEFT INTERNAL ILIAC ARTERY, THE CATHETER DETACHED. IN AN ATTEMPT TO CAPTURE THE COMPONENTS WITH A SNARE LOOP, THEY FRAGMENTED AND WERE THEN STABILIZED IN THE INTERNAL ILIAC ARTERIES, LEFT DEEP FEMORAL ARTERY, AND LEFT PERONEAL ARTERY. NO ADDITIONAL INFORMATION AVAILABLE.

  Patient problems: Foreign Body In Patient

  MAUDE report 18736019 ↗
• InjuryNov 20, 2023Fracture; Material Separation; Fracture; Material Separation

  THE ACCOUNT ALLEGES THAT TIP OF THE CATHETER GOT DETACHED WHEN IT WAS PULLED INTO A SHEATH DURING TEVAR PROCEDURE. NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18172750 ↗
• InjuryNov 20, 2023Fracture; Material Separation; Fracture; Material Separation

  THE ACCOUNT ALLEGES THAT DURING AN ABDOMINAL STENTGRAFT PLACEMENT PROCEDURE (EVAR), THE TIP OF THE CATHETER BROKE OFF. THIS OCCURRED DURING MANIPULATION WITHIN THE DEPLOYED STENTGRAFT. WHEN BRINGING THE CATHETER TO THE RIGHT INTERNAL ILIAC ARTERY, IT WAS THEN BROUGHT TO THE AORTA AND THE CATHETER TIP WAS RETURNED TO A MODIFIED HOOK. WHEN THE CATHETER WAS MOVED DOWN WITHIN THE LOWER EXTREMITY, THAT IS WHEN THE TIP DETACHED. THE TIP WAS NOT ABLE TO BE REMOVED FROM THE PATIENT AND WAS LEFT WITHIN THE PATIENT'S VESSEL. THE GRAFT WAS DEPLOYED AND THE TIP OF THE CATHETER REMAINS BETWEEN THE GRAFT AND THE VESSEL.

  Patient problems: Foreign Body In Patient

  MAUDE report 18172747 ↗
• InjuryOct 31, 2023Fracture; Material Separation; Fracture; Material Separation

  THE ACCOUNT ALLEGES THAT THE DISTAL END OF THE CATHETER BROKE OFF WITHIN THE PATIENT DURING THE PROCEDURE. NO ADDITIONAL INFORMATION AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18038422 ↗