Impress® 00884450009437Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00884450009437), received between May 6, 2021 and Jun 1, 2022 — 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.

• InjuryJun 1, 2022Fracture; Material Separation; Fracture; Material Separation

  THE ACCOUNT ALLEGES THAT DURING AN ENDOVASCULAR PROCEDURE, THE CATHETER TIP DETACHED WITHIN THE PATIENT. THE PHYSICIAN HAD ACQUIRED VASCULAR ACCESS AND DURING CATHETER MANIPULATIONS OVER A GUIDEWIRE UNDER FLUOROSCOPY THE CATHETER TIP DETACHED. THE PHYSICIAN WAS ABLE TO SUCCESSFULLY EXTERNALIZED THE FOREIGN BODY FROM THE PATIENT WITH A VASCULAR SNARE DEVICE THUS LIBERATING THE VESSEL. THE PATIENT TOLERATED THE PROCEDURE WELL. NO ADDITIONAL PATIENT CONSEQUENCES TO REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14569837 ↗
• InjuryJun 1, 2022Fracture; Material Separation; Fracture; Material Separation

  THE ACCOUNT ALLEGES THAT DURING AN ENDOVASCULAR PROCEDURE, THE CATHETER TIP DETACHED WITHIN THE PATIENT. THE PHYSICIAN HAD ACQUIRED VASCULAR ACCESS AND DURING CATHETER MANIPULATIONS UNDER FLUOROSCOPY THE CATHETER TIP DETACHED AND MIGRATED INTO THE PATIENTS LUNG. THE PATIENT WAS TRANSFERRED TO IR DEPARTMENT FOR FOREIGN BODY REMOVAL. THE PATIENT TOLERATED THE PROCEDURE WELL. NO ADDITIONAL PATIENT CONSEQUENCES TO REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14569801 ↗
• InjuryJul 13, 2021Fracture; Material Separation; Fracture; Material Separation

  THE ACCOUNT ALLEGES THAT DURING THE PROCEDURE THE TIP OF THE IMPRESS CATHETER BROKE OFF. THE TIP HAD TO BE RETRIEVED USING A SNARE DEVICE.

  Patient problems: Foreign Body In Patient

  MAUDE report 12160296 ↗
• InjuryJul 13, 2021Fracture; Material Separation; Fracture; Material Separation

  THE ACCOUNT ALLEGES THAT DURING THE PROCEDURE THE TIP OF THE IMPRESS CATHETER BROKE OFF. NO PATIENT INJURY TO REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12160294 ↗
• MalfunctionMay 13, 2021Fracture; Fracture

  THE ACCOUNT ALLEGES WHILE MANIPULATING THE CATHETER WITHIN THE PATIENT'S BLADDER, THE TIP OF THE DEVICE STARTED TO SHEAR AWAY FROM THE REST OF THE DEVICE. THE CATHETER WAS REMOVED COMPLETELY WITHOUT AN ADDITIONAL PROCEDURE OR INTERVENTIONAL DEVICE REQUIRED. NO PATIENT INJURY TO REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11816073 ↗
• InjuryMay 6, 2021Fracture; Fracture

  THE ACCOUNT ALLEGES DURING A PROCEDURE THE BLACK RADIOPAQUE TIP OF THE CATHETER DETACHED FROM THE REST OF THE DEVICE. THE PHYSICIAN USED AN ENSNARE DEVICE TO RETRIEVE THE DETACHED TIP. THE PROCEDURE WAS SUCCESSFUL AND THERE ARE NO ADDITIONAL PATIENT CONSEQUENCES TO REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11787812 ↗