Impress® 00884450023198Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00884450023198), received between Nov 30, 2021 and Jun 29, 2022 — classified as 5 injuries.

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 18, 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.

• InjuryJun 29, 2022Fracture; Material Separation; Fracture; Material Separation

  THE ACCOUNT ALLEGES THAT DURING PERIPHERAL VASCULAR IMAGING OF THE LEFT LEG THE 4F CATHETER TIP DETACHED. THE PHYSICIAN HAD ACQUIRED BILATERAL RETROGRADE FEMORAL ARTERY ACCESS, AND DURING A CATHETER EXCHANGE, OVER A STIFF GUIDEWIRE UNDER FLUOROSCOPY, THE CATHETER TIP DETACHED. THE PHYSICIAN USED A VASCULAR SNARE DEVICE TO SUCCESSFULLY EXTERNALIZE THE FREE-FLOATING FOREIGN BODY FROM THE PATIENT LIBERATING THE VESSEL. NO ADDITIONAL PATIENT CONSEQUENCES TO REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14861030 ↗
• InjuryMay 4, 2022Fracture; Material Separation; Fracture; Material Separation

  THE ACCOUNT ALLEGES THAT DURING A PERIPHERAL VASCULAR INTERVENTION, THE CATHETER TIP DETACHED WITHIN THE PATIENT'S LEFT COMMON ILIAC ARTERY. THE PHYSICIAN HAD ACQUIRED CONTRALATERAL RETROGRADE RIGHT FEMORAL ARTERY ACCESS WITH A PERIPHERAL SHEATH. DURING CATHETER MANIPULATIONS OVER A GUIDEWIRE, THE CATHETER TIP DETACHED WITHIN THE PATIENT COMMON ILIAC ARTERY. THE PHYSICIAN WAS ABLE TO SUCCESSFULLY EXTERNALIZED THE FOREIGN BODY FROM THE PATIENT LIBERATING THE ILIAC CONDUIT.. ANOTHER CATHETER WAS USED TO COMPLETE THE PROCEDURE. NO ADDITIONAL PATIENT CONSEQUENCES TO REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14283050 ↗
• InjuryApr 19, 2022Fracture; Material Separation; Fracture; Material Separation

  THE ACCOUNT ALLEGES THAT DURING A PERIPHERAL ENDOVASCULAR PROCEDURE, THE CATHETER TIP DETACHED WITHIN THE PATIENT. THE PHYSICIAN HAD ACQUIRED RIGHT RETROGRADE FEMORAL ARTERY ACCESS AND HAD NEGOTIATED THE PATIENT'S COMMON ILIAC BIFURCATION UNDER FLUOROSCOPY WITH A GUIDEWIRE AND A 4F CATHETER. THE PHYSICIAN NOTED THAT THE BILATERAL COMMON ILIAC ARTERIES HAD BEEN PREVIOUSLY STENTED. DURING CATHETER MANIPULATIONS OVER A STIFF GUIDEWIRE WITHIN THE PATIENT'S ABDOMINAL AORTA, THE CATHETER TIP DETACHED. THE PHYSICIAN USED A VASCULAR SNARE DEVICE TO SUCCESSFULLY EXTERNALIZED THE FOREIGN BODY LIBERATING THE VESSEL. THE PATIENT TOLERATED THE PROCEDURE WELL WITH NO ADDITIONAL PATIENT CONSEQUENCES TO REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14145006 ↗
• InjuryMar 1, 2022Fracture; Material Separation; Fracture; Material Separation

  THE ACCOUNT ALLEGES THAT DURING A PERIPHERAL VASCULAR PROCEDURE, A CATHETER TIP DETACHED WITHIN THE PATIENT. THE PHYSICIAN HAD SUCCESSFULLY ACQUIRED RETROGRADE ARTERIAL ACCESS AND HAD NEGOTIATED THE PATIENT'S ILIO-FEMORAL CONDUIT WITH AN INTERVENTIONAL GUIDEWIRE AND 4F CATHETER. THE PHYSICIAN STATES THAT DURING A DIFFICULT CATHETER REMOVAL PROCESS, FROM THE PATIENT'S COMMON ILIAC ARTERY THE CATHETER HUB DETACHED. ADDITIONAL ATTEMPTS IN REMOVING THE CATHETER FROM THE PATIENT RESULTED IN CATHETER TIP DETACHMENT AS WELL. REMOVAL OF THE REMAINING CATHETER WAS NOT DIFFICULT. THE PHYSICIAN EXCHANGED THE PRIMARY SHEATH FOR A LONGER 6F SECONDARY SHEATH FOR FOREIGN BODY REMOVAL. THE SHEATH WAS ADVANCED OVER THE DETACHED FOREIGN BODY SUCCESSFULLY AND REMOVED LIBERATING THE PATIENT'S ILIAC CONDUIT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13640690 ↗
• InjuryNov 30, 2021Fracture; Fracture

  THE ACCOUNT ALLEGES THAT DURING A PROCEDURE THE CATHETER TIP DETACHED WITHIN THE PATIENT. THE PHYSICIAN USED A VASCULAR SNARE DEVICE TO SUCCESSFULLY EXTERNALIZED THE FOREIGN BODY LIBERATING THE VASCULATURE. NO ADDITIONAL PATIENT CONSEQUENCES TO REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12902300 ↗