Impress® 00884450042366Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00884450042366), received between Jul 16, 2020 and Jun 9, 2021 — classified as 1 injury, 1 malfunction.

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.

• InjuryJun 9, 2021Fracture; Material Separation; Fracture; Material Separation

  THE ACCOUNT ALLEGES THAT DURING A PERIPHERAL VASCULAR INTERVENTIONAL PROCEDURE, A DIAGNOSTIC CATHETER TIP DETACHED WITHIN THE PATIENT. THE PHYSICIAN HAD ACQUIRED RETROGRADE ARTERIAL ACCESS AND HAD NEGOTIATED THE PATIENT'S ILIAC BIFURCATION UNDER FLUOROSCOPY OVER A GUIDEWIRE WITH THE 4F CATHETER. DURING CATHETER MANIPULATIONS WITHIN THE PATIENT'S TIBIAL ARTERY, THE CATHETER TIP DETACHED. THE PHYSICIAN SUCCESSFULLY USED A VASCULAR SNARE DEVICE TO RETRIEVE THE FOREIGN BODY FROM THE PATIENT. THE PATIENT TOLERATED THE PROCEDURE WELL WITH NO ADDITIONAL CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11972056 ↗
• MalfunctionJul 16, 2020Fracture; Material Separation; Fracture; Material Separation

  THE ACCOUNT ALLEGES THAT DURING A VASCULAR SURGERY PROCEDURE, THE CATHETER TIP DETACHED WITHIN THE PATIENT. THE PHYSICIAN HAD ACQUIRED RETROGRADE ARTERIAL ACCESS AND DURING CATHETER REMOVAL -OVER THE WIRE- THE CATHETER TIP STARTED TO DETACH WITHIN THE PATIENT'S BRACHIAL ARTERY. THE CATHETER WAS SAFELY REMOVED FROM THE PATIENT WHEN THE TIP FINALLY DETACHED FROM THE CATHETER. NO FOREIGN BODY RETRIEVAL WAS NECESSARY. NO PATIENT INJURY TO REPORT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10283492 ↗