Impress® 00884450038048Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00884450038048), received between Jan 10, 2020 and Jul 5, 2023 — classified as 4 injuries, 1 malfunction.

The most frequently reported specific device problem is “Fracture” (5 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryJul 5, 2023Fracture; Material Separation; Fracture; Material Separation

  THE ACCOUNT ALLEGES THAT DURING A PERCUTANEOUS TRANSLUMINAL RENAL ARTERY INTERVENTION, THE CATHETER TIP DETACHED WITHIN THE PATIENT. THE PHYSICIAN HAD ACQUIRED ARTERIAL ACCESS WITH A GUIDEWIRE AND THE 4F CATHETER. DURING OVER-THE-WIRE CATHETER MANIPULATIONS WITHIN THE RENAL ARTERY, UNDER FLUOROSCOPY, THE TIP DETACHED. THE PHYSICIAN USED A RETRIEVAL BASKET TO SUCCESSFULLY EXTERNALIZE THE FOREIGN BODY LIBERATING THE VESSEL. THE PATIENT TOLERATED THE PROCEDURE WELL WITH NO OTHER CONSEQUENCES TO REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17263192 ↗
• InjuryOct 25, 2022Fracture; Material Separation; Fracture; Material Separation

  THE ACCOUNT ALLEGES THAT DURING USE, THE CATHETER FRACTURED. NO PATIENT INJURY TO REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15671056 ↗
• InjuryMay 19, 2022Fracture; Material Separation; Fracture; Material Separation

  THE ACCOUNT ALLEGES THAT DURING THE PROCEDURE, THE TIP OF THE CATHETER DETACHED WITHIN THE PATIENT'S VESSEL. THE DETACHED PIECE WAS SUCCESSFULLY REMOVED A SNARE SYSTEM. NO ADDITIONAL PATIENT CONSEQUENCE TO REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14439289 ↗
• MalfunctionSep 15, 2021Fracture; Fracture

  THE ACCOUNT ALLEGES THAT DURING A TACE PROCEDURE, RADIAL APPROACH, THE CATHETER TIP DETACHED WITHIN THE PATIENT AFTER INJECTING WITH LIPIODOL MIXTURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12478465 ↗
• InjuryJan 10, 2020Fracture; Material Separation; Fracture; Material Separation

  THE ACCOUNT ALLEGES THAT THE TIP OF THE CATHETER DETACHED WITHIN THE PATIENT. THE PHYSICIAN WAS ABLE TO REMOVE THE DETACHED PORTION WITH ANOTHER CATHETER USING A "STOVEPIPE" METHOD TO ENCAPSULATE THE TIP WITHIN A NEW CATHETER. NO PATIENT INJURY WAS REPORTED.

  Patient problems: Foreign Body In Patient

  MAUDE report 9575031 ↗