Impress® 00884450024928Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00884450024928), received between Sep 26, 2023 and Nov 20, 2023 — classified as 4 injuries.

The most frequently reported specific device problem is “Fracture” (4 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryNov 20, 2023Fracture; Material Separation; Fracture; Material Separation

  THE ACCOUNT ALLEGES THAT TWO CATHETER TIPS DETACHED WITHIN THE PATIENT'S COMMON ILIAC ARTERIES DURING CATHETER EXCHANGES. THE PROCEDURE WAS AN INFRARENAL AORTIC ANEURYSM REPAIR WITH NOTED TORTUOUS LEFT COMMON ILIAC ARTERY AND CALCIFIED RIGHT CFA BILATERAL ACCESS SITE. THE RIGHT ACCESS WIRE WAS EXCHANGED [OTW] FOR A STIFF GUIDEWIRE DURING THE PROCEDURE AND WHEN THE CATHETER WAS WITHDRAWN, THE CATHETER TIP BECAME STUCK AND DETACHED. THE LEFT GUIDEWIRE WAS ALSO EXCHANGED [OTW] FOR A STIFF HYDROPHILIC WIRE DURING THE PROCEDURE AND WHEN THE SECOND CATHETER WAS WITHDRAWN, THE CATHETER TIP BECAME STUCK AND DETACHED AS WELL. BOTH FOREIGN BODIES WERE SUCCESSFULLY SNARED AND REMOVED FROM THE PATIENT WITH NO ADDITIONAL CONSEQUENCES TO REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18178464 ↗
• InjuryNov 20, 2023Fracture; Material Separation; Fracture; Material Separation

  THE ACCOUNT ALLEGES THAT TWO CATHETER TIPS DETACHED WITHIN THE PATIENT'S COMMON ILIAC ARTERIES DURING CATHETER EXCHANGES. THE PROCEDURE WAS AN INFRARENAL AORTIC ANEURYSM REPAIR WITH NOTED TORTUOUS LEFT COMMON ILIAC ARTERY AND CALCIFIED RIGHT CFA BILATERAL ACCESS SITE. THE RIGHT ACCESS WIRE WAS EXCHANGED [OTW] FOR A STIFF GUIDEWIRE DURING THE PROCEDURE AND WHEN THE CATHETER WAS WITHDRAWN, THE CATHETER TIP BECAME STUCK AND DETACHED. THE LEFT GUIDEWIRE WAS ALSO EXCHANGED [OTW] FOR A STIFF HYDROPHILIC WIRE DURING THE PROCEDURE AND WHEN THE SECOND CATHETER WAS WITHDRAWN, THE CATHETER TIP BECAME STUCK AND DETACHED AS WELL. BOTH FOREIGN BODIES WERE SUCCESSFULLY SNARED AND REMOVED FROM THE PATIENT WITH NO ADDITIONAL CONSEQUENCES TO REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18178463 ↗
• InjuryNov 15, 2023Fracture; Material Separation; Fracture; Material Separation

  THE ACCOUNT ALLEGES THAT DURING AN INTERVENTIONAL PERIPHERAL VASCULAR PROCEDURE, A CATHETER TIP DETACHED WITHIN THE PATIENT. THE PHYSICIAN USED A VASCULAR SNARE DEVICE TO SUCCESSFULLY EXTERNALIZE THE FOREIGN BODY LIBERATING THE PATIENT'S VESSEL. NO ADDITIONAL PATIENT CONSEQUENCES TO REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18143017 ↗
• InjurySep 26, 2023Fracture; Material Separation; Fracture; Material Separation

  THE ACCOUNT ALLEGES THAT DURING AN INTERVENTIONAL PERIPHERIAL VASCULAR PROCEDURE, THE CATHETER TIP DETACHED AND REMAINED ON THE GUIDEWIRE.THE GIODEWORE AND CATHETER WERE REMOVED TOGETHER WITHOUT CONCEQUENCE TO THE PATIENT. A NEW CATHETER WAS USED TO COMPLETE THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17821691 ↗