Impress® 00884450011485Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00884450011485), received between Apr 10, 2017 and Feb 11, 2026 — classified as 1 injury, 3 malfunctions.

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 18, 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.

• MalfunctionFeb 11, 2026Fracture

  ACCOUNT REPORT THAT DURING TREATMENT OF AN ENDOLEAK IN A STENT-GRAFT, THE BLACK TIP OF THE IMPRESS CATHETER DETACHED. THE OPERATOR HANDLED THE IMPRESS CAREFULLY IN THIS CASE AND DID NOT PERFORM ANY EXCESSIVE MANIPULATION. HE ALSO REPORTED THAT THE IMPRESS DID NOT GET CAUGHT ON THE STENT GRAFT OR OTHERWISE EXERT EXCESSIVE PRESSURE. THE TIP WAS RETRIEVED WITH A CUT-DOWN AND A 14FR COOK CHECK-FLO. IT WAS FOUND THAT THE COMPLAINT PRODUCT HAD PASSED ITS EXPIRATION DATE.

  Patient problems: Foreign Body In Patient

  MAUDE report 24312515 ↗
• MalfunctionJul 8, 2025Incomplete or Missing Packaging; Manufacturing, Packaging or Shipping Problem; Packaging Problem; Incomplete or Missing Packaging; Manufacturing, Packaging or Shipping Problem; Packaging Problem

  THE ACCOUNT ALLEGES THAT THERE WAS A DEFECT IN THE PACKAGING RESULTING IN INCOMPLETE STERILIZATION OF THE CONTENTS. THE DEFECT WAS IDENTIFIED DURING PREPARATIONS FOR A MEDICAL PROCEDURE. NO PATIENT INTERACTION OR INJURY TO REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22445425 ↗
• InjuryNov 1, 2019Fracture; Material Separation; Fracture; Material Separation

  THE ACCOUNT ALLEGES THAT DURING AN ENDOVASCULAR AORTIC ANEURYSM REPAIR PROCEDURE, A CATHETER TIP DETACHED WITHIN THE PATIENT. THE PHYSICIAN HAD ACQUIRED RETROGRADE FEMORAL ARTERY ACCESS. DURING CATHETER MANIPULATIONS OVER A STIFF GUIDEWIRE, THE CATHETER KINKED AND DETACHED WITHIN THE PATIENT'S IPSILATERAL COMMON ILIAC ARTERY. THE PHYSICIAN WAS ABLE TO SUCCESSFULLY REMOVE THE CATHETER TIP FROM THE PATIENT WITH A VASCULAR SNARE DEVICE. NO ADDITIONAL PATIENT CONSEQUENCES TO REPORT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9266964 ↗
• MalfunctionApr 10, 2017Detachment Of Device Component

  TIP CAME APART FROM MAIN CATHETER.

  Patient problems: No Information

  MAUDE report 6485416 ↗