Impress® 00884450668122Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00884450668122), received between Jun 27, 2023 and Aug 6, 2025 — classified as 5 injuries, 1 malfunction.

The most frequently reported specific device problem is “Fracture” (6 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 6, 2025Fracture; Fracture

  A RADIOLOGIST WAS PERFORMING AN ILIAC ANGIOPLASTY. WHILE ATTEMPTING TO PASS CATHETER THROUGH STENOSED ILIAC ARTERY, AROUND 5CM OF TIP OF CATHETER BROKE OFF AND HAD TO BE RETRIEVED. THE RADIOLOGIST WAS ABLE TO RETRIEVE THE TIP BY USING AN ANGIOPLASTY BALLOON AND STENT TO OPEN VESSELS AROUND FRAGMENT. NO REPORTED INJURY OR ADDITIONAL PATIENT DETAILS WERE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22731505 ↗
• InjuryMay 27, 2025Fracture; Material Separation; Fracture; Material Separation

  THE ACCOUNT ALLEGES AFTER INSERTING THE DEVICES INTO THE PATIENT AND ATTEMPTING TO REMOVE THE RIM PROBE FROM THE INTRODUCER, IT FRACTURED, LEAVING THE BASE IN THE ILIAC ARTERY. THE FOREIGN BODY WAS SUCCESSFULLY REMOVED. NO ADDITIONAL PATIENT CONSEQUENCE TO REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22091829 ↗
• InjuryNov 19, 2024Fracture; Material Separation; Fracture; Material Separation

  THE ACCOUNT ALLEGES THAT DURING THE PROCEDURE THE BLACK TIP OF THE CATHETER SNAPPED WHILST TRYING TO REMOVE THE CATHETER OVER AN AMPLTAZ GUIDEWIRE. THE TIP WAS SUCCESSFULLY RETRIEVED. NO ADDITIONAL PATIENT CONSEQUENCES TO REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20726829 ↗
• InjurySep 18, 2024Fracture; Material Separation; Fracture; Material Separation

  THE ACCOUNT ALLEGES THAT DURING ARTERIAL ACCESS FOR A PERIPHERAL VASCULAR INTERVENTION, THE CATHETER TIP DETACHED AT THE BLACK DISTAL TIP. THE DETACHED DEVICE WAS SUCCESSFULLY RECOVERED USING AN ENDOVASCULAR SNARE REMOVAL. NO ADDITIONAL PATIENT CONSEQUENCE TO REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20248170 ↗
• InjuryAug 27, 2024Fracture; Material Separation; Fracture; Material Separation

  THE ACCOUNT ALLEGES THE TIP OF A RIM CATHETER BROKE OFF IN A PATIENT'S VESSEL DURING A ROUTINE AV FISTULOGRAM. IT WAS RETRIEVED WITH A SNARE DEVICE AND THE PATIENT WAS NOT HARMED. NO ADDITIONAL PATIENT CONSEQUENCE TO REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20081833 ↗
• InjuryJun 27, 2023Fracture; Material Separation; Fracture; Material Separation

  THE ACCOUNT ALLEGES THAT DURING AN ANGIOGRAM PROCEDURE THE TIP OF THE CATHETER DETACHED WITHIN THE PATIENT. WHILE ATTEMPTING TO CROSS THROUGH THE COMMON ILIAC ARTERY, THE TIP OF THE DEVICE GOT STUCK WITHIN THE HIGHLY CALCIFIED VESSEL AND DETACHED WITHIN THE PATIENT. THERE WAS AN ATTEMPT TO REMOVE THE FOREIGN BODY USING A SNARE, AND WAS UNSUCCESSFUL. THE PATIENT WAS SENT TO SURGERY TO REMOVE THE DETACHED TIP. NO ADDITIONAL PATIENT CONSEQUENCE TO REPORT.

  Patient problems: Foreign Body In Patient

  MAUDE report 17213892 ↗