Impress® 00884450043509Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00884450043509), received between May 11, 2021 and Mar 28, 2023 — classified as 2 injuries.

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 18, 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.

• InjuryMar 28, 2023Fracture; Material Separation; Fracture; Material Separation

  THE ACCOUNT ALLEGES THAT DURING AN ANGIOPLASTY PROCEDURE ON A CHILD, THE TIP OF THE 5F BRAIDED CATHETER DETACHED IN THE PATIENT. THE PHYSICIAN SUCCESSFULLY EXTERNALIZED THE FOREIGN BODY FROM THE PATIENT LIBERATING THE VESSEL. AN ADDITIONAL CATHETER WAS USED TO COMPLETE THE PROCEDURE, NO ADDITIONAL PATIENT CONSEQUENCES TO REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16633135 ↗
• InjuryMay 11, 2021Fracture; Material Separation; Fracture; Material Separation

  ACCOUNT ALLEGES THAT AN IMPRESS CATHETER TIP BROKE OFF INSIDE A PATIENT. CATHETER WAS INSERTED OVER THE WIRE AND ADVANCED INTO THE KIDNEY. WIRE WAS REMOVED AND THEY NOTICED THE BLACK TIP OF THE CATHETER WAS NO LONGER ON THE END OF CATHETER. CATHETER TIP WAS REMOVED VIA SNARE AND USED ANOTHER CATHETER AND PROCEEDED WITHOUT INCIDENT. NO PATIENT HARM.

  Patient problems: Foreign Body In Patient

  MAUDE report 11809228 ↗