Impress® 00884450023204Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00884450023204), received between Mar 24, 2021 and Aug 17, 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.

• InjuryAug 17, 2022Fracture; Material Separation; Fracture; Material Separation

  THE ACCOUNT ALLEGES THAT DURING THE PROCEDURE, THE CATHETER TIP DETACHED WITHIN THE PATIENT. THE DETACHED PIECE WAS SUCCESSFULLY REMOVED. NO ADDITIONAL PATIENT CONSEQUENCE TO REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15246760 ↗
• MalfunctionOct 13, 2021Fracture; Material Separation; Fracture; Material Separation

  THE ACCOUNT ALLEGES THAT DURING A VASCULAR PROCEDURE THE CATHETER TIP DETACHED WITHIN THE PATIENT. THE FOREIGN BODY WAS SUCCESSFULLY EXTERNALIZED BY THE ATTENDING CLINICIAN. NO ADDITIONAL CONSEQUENCES TO REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12626081 ↗
• InjuryMar 24, 2021Fracture; Difficult to Remove; Material Separation; Fracture; Difficult to Remove; Material Separation

  THE ACCOUNT ALLEGES THAT DURING A PERIPHERAL VASCULAR INTERVENTIONAL PROCEDURE ON (B)(6) 2021, THE CATHETER TIP DETACHED WITHIN THE PATIENT. THE PHYSICIAN HAD ACQUIRED RETROGRADE ARTERIAL ACCESS AND HAD SUCCESSFULLY NEGOTIATED THE PATIENT'S ABDOMINAL AORTIC BIFURCATION WITH AN .038 GUIDEWIRE AND GUIDE CATHETER UNDER FLUOROSCOPY. THE PHYSICIAN WAS ATTEMPTING TO REMOVE THE GUIDE CATHETER WHEN HE FELT THE CATHETER TIP DETACH WITHIN THE PATIENT'S ABDOMINAL AORTIC ARCH. THE PHYSICIAN SUCCESSFULLY REMOVED THE FOREIGN BODY FROM THE PATIENT WITH A VASCULAR SNARE DEVICE. THE PATIENT TOLERATED THE PROCEDURE WELL. NO ADDITIONAL CONSEQUENCES TO REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11562426 ↗