Impress® 00884450043363Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00884450043363), received between Aug 29, 2023 and Oct 18, 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. How this data works · Data updated Oct 13, 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.

• InjuryOct 18, 2023Fracture; Material Separation; Fracture; Material Separation

  THE ACCOUNT ALLEGES THAT DURING THE ILIAC ARTERIOGRAPHY PROCEDURE, THE CATHETER TIP CRACKED AND SEPARATED WITHIN THE PATIENT. THE CLINICIAN SUCCESSFULLY REMOVED THE DETACHED PIECES USING A CAPTURE DEVICE. NO ADDITIONAL PATIENT CONSEQUENCE TO REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17959201 ↗
• InjuryAug 29, 2023Fracture; Material Separation; Fracture; Material Separation

  THE ACCOUNT ALLEGES THAT DURING A PERCUTANEOUS TRANSLUMINAL PAN ANGIOGRAPHY CATHETERIZATION PROCEDURE, THE CATHETER TIP DETACHED. THE PHYSICIAN HAD ACQUIRED RETROGRADE ARTERIAL VASCULAR ACCESS AND HAD NEGOTIATED THE PATIENT'S LEFT CAROTID ARTERY FOR VARIOUS SELECTED ANGIOGRAMS OF THE PATIENT'S CEREBRAL VASCULAR SYSTEM. A 5F CATHETER AND INTERVENTIONAL GUIDEWIRE WERE USED TO SUCCESSFULLY NAVIGATE UNDER FLUOROSCOPY THE VASCULAR ANATOMY. DURING PRIMARY CATHETER MANIPULATIONS, THE TIP OF THE 5F CATHETER DETACHED AND MIGRATED TO THE PATIENT'S LEFT CAROTID ARTERY, FINALLY LODGING WITHIN A BRANCH OF THE PATIENT'S PARIETAL ARTERY. THE ATTENDING PHYSICIAN ATTEMPTED TO EXCISE THE IATROGENIC FOREIGN BODY [IFB] FROM THE PATIENT WITH NO SUCCESS. THE DECISION WAS MADE TO LEAVE THE IFB IN VIVO AT THIS TIME. THE PATIENT REQUIRED AN ADDITIONAL MEDICAL INTERVENTION TO PREVENT PERMANENT CEREBRAL VASCULAR DAMAGE.

  Patient problems: Foreign Body In Patient

  MAUDE report 17643156 ↗