Impress® 00884450018897Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00884450018897), received between May 11, 2021 and May 25, 2022 — classified as 2 injuries, 1 malfunction.

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.

• InjuryMay 25, 2022Fracture; Material Separation; Fracture; Material Separation

  THE ACCOUNT ALLEGES THAT DURING A PERIPHERAL VASCULAR INTERVENTION, THE CATHETER TIP DETACHED WITHIN THE PATIENT'S LOWER PERIPHERY. THE PHYSICIAN HAD ACQUIRED VASCULAR ACCESS AND DURING CATHETER MANIPULATIONS WITHIN THE IVC THE CATHETER DETACHED. THE PHYSICIAN WAS ABLE TO SUCCESSFULLY EXTERNALIZED THE FOREIGN BODY FROM THE PATIENT THUS LIBERATING THE VESSEL. NO ADDITIONAL PATIENT CONSEQUENCES TO REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14501644 ↗
• MalfunctionMay 19, 2021Fracture; Material Separation; Fracture; Material Separation

  THE ACCOUNT ALLEGES THE DEVICE WAS USED TO COMPLETE A TEVAR PROCEDURE. WHEN WITHDRAWING THE DEVICE AFTER THE PROCEDURE THE TIP DETACHED FROM THE REST OF THE CATHETER. THE DETACHED PORTION WAS FOUND WITHIN THE SHEATH AND REMOVED WITH THE SHEATH FROM THE PATIENT. NO ADDITIONAL PATIENT CONSEQUENCES TO REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11852004 ↗
• InjuryMay 11, 2021Fracture; Material Separation; Fracture; Material Separation

  THE ACCOUNT ALLEGES THAT DURING A PROCEDURE THE DISTAL END OF THE STIFF GUIDEWIRE CATHETER RUPTURED WHILE IN THE LEFT SUPERFICIAL FEMORAL CROSSOVER. REMOVAL OF THE LEAD WAS DIFFICULT AND THE RUPTURE OCCURRED WHEN CROSSING THE AORTOFEMORAL BIFURCATION. THE DEVICE WAS REMOVED USING A LASSO.

  Patient problems: Foreign Body In Patient

  MAUDE report 11809244 ↗