Impress® 00884450009376Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00884450009376), received between Dec 15, 2020 and Dec 20, 2021 — classified as 3 injuries.

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.

• InjuryDec 20, 2021Fracture; Material Separation; Fracture; Material Separation

  THE ACCOUNT ALLEGES DURING A DIAGNOSTIC PROCEDURE THE IMPRESS CATHETER BROKE INTO 2 PIECES WHILE WITHIN THE PATIENT. BOTH PIECES WERE SUCCESSFULLY RETRIEVED FROM THE PATIENT. NO ADDITIONAL PATIENT CONSEQUENCE TO REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13048259 ↗
• InjuryDec 16, 2020Fracture; Material Separation; Fracture; Material Separation

  THE ACCOUNT ALLEGES THAT DURING A UTERINE ARTERY EMBOLIZATION [UAE] PROCEDURE, THE CATHETER TIP DETACHED WITHIN THE PATIENT. THE PHYSICIAN HAD ACQUIRED RETROGRADE ARTERIAL ACCESS AND DURING CATHETER MANIPULATIONS UNDER FLUOROSCOPY, OVER A GUIDE WIRE THE CATHETER TIP DETACHED. THE PHYSICIAN SUCCESSFULLY RETRIEVED THE FOREIGN BODY FROM THE PATIENT. THE PATIENT TOLERATED THE PROCEDURE WELL AND WAS DISCHARGED TO HOME WITH NO ADDITIONAL CONSEQUENCES TO REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11020459 ↗
• InjuryDec 15, 2020Fracture; Material Separation; Fracture; Material Separation

  THE ACCOUNT ALLEGES THAT DURING A UTERINE ARTERY EMBOLIZATION [UAE] PROCEDURE, THE CATHETER TIP DETACHED WITHIN THE PATIENT. THE PHYSICIAN HAD ACQUIRED RETROGRADE ARTERIAL ACCESS AND DURING CATHETER MANIPULATIONS UNDER FLUOROSCOPY, OVER A GUIDE WIRE THE CATHETER TIP DETACHED. THE PHYSICIAN SUCCESSFULLY RETRIEVED THE FOREIGN BODY FROM THE PATIENT. THE PATIENT TOLERATED THE PROCEDURE WELL AND WAS DISCHARGED TO HOME WITH NO ADDITIONAL CONSEQUENCES TO REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11013379 ↗