Impress® 00884450009116Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00884450009116), received between Oct 3, 2019 and Mar 19, 2022 — classified as 3 injuries.

The most frequently reported specific device problem is “Fracture” (3 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryMar 19, 2022Fracture; Fracture

  THE CUSTOMER REPORTS THAT THEY HAD A TIP DETACHMENT DURING STENTGRAFT FOR AN ABDOMINAL EVAR PROCEDURE. WHEN AN IMPRESS CATHETER WAS ATTEMPTED TO BE WITHDRAWN FROM A PATIENT, THE OPERATOR FELT PHYSICAL RESISTANCE, AND UPON REMOVAL, THE TIP OF THE CATHETER BROKE OFF, AT THE LEG OF THE STENTGRAFT, WITHIN ABDOMINAL AORTA. THE SEPARATION WAS AT THE BORDER BETWEEN THE BLACK AND PURPLE PORTIONS AT THE TIP, AND ITS CROSS SECTION WAS FOUND TO BE SMOOTH. THE DETACHED TIP WAS SUCCESSFULLY RETRIEVED BY ENDOVASCULAR PROCEDURE WITH A SNARE CATHETER. NO ADDITIONAL ADVERSE EVENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13825555 ↗
• InjuryJan 12, 2022Fracture; Material Separation; Fracture; Material Separation

  THE ACCOUNT ALLEGES THAT DURING AN STENTGRAFT FOR AN ABDOMINAL EVAR PROCEDURE THE CATHETER TIP DETACHED. THE CATHETER WAS ATTEMPTED TO BE WITHDRAWN FROM A PATIENT, THE OPERATOR FELT PHYSICAL RESISTANCE, AND UPON REMOVAL, THE TIP OF THE CATHETER DETACHED AT THE LEG OF THE STENTGRAFT WITHIN ABDOMINAL AORTA. THE SEPARATION WAS AT THE BORDER BETWEEN THE BLACK AND PURPLE PORTIONS AT THE TIP, AND ITS CROSS SECTION WAS FOUND TO BE SMOOTH. THE DETACHED TIP WAS SUCCESSFULLY RETRIEVED BY ENDOVASCULAR SNARE DEVICE. NO ADDITIONAL ADVERSE EVENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13241047 ↗
• InjuryOct 3, 2019Fracture; Material Separation; Fracture; Material Separation

  THE ACCOUNT ALLEGES THAT FOLLOW-UP SURGERY WAS PERFORMED ON THIS PATIENT (B)(6) 2019. THE PHYSICIAN STATES THAT SOME FOREIGN BODY REMAIN WITHIN THE PATIENT AND DUE THE PATIENT'S AGE, PHYSICAL CONDITION AND FAMILY CONCERNS, THE DECISION WAS MADE NOT TO CONTINUE WITH ADDITIONAL REMOVAL ATTEMPTS.

  Patient problems: Foreign Body In Patient

  MAUDE report 9151972 ↗