Impress® 00884450038161Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00884450038161), received between Jun 1, 2022 and Jan 24, 2024 — classified as 6 injuries.

The most frequently reported specific device problem is “Fracture” (6 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• InjuryJan 24, 2024Fracture; Material Separation; Fracture; Material Separation

  THE ACCOUNT ALLEGES THAT DURING A PROCEDURE THE DISTAL END OF THE CATHETER BROKE OFF INSIDE THE PATIENT. THE PHYSICIAN SUCCESSFULLY EXTERNALIZED THE FOREIGN BODY WITH A VASCULAR SNARE DEVICE LIBERATING THE VESSEL. NO ADDITIONAL PATIENT CONSEQUENSES TO REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18571586 ↗
• InjuryJun 14, 2023Fracture; Material Separation; Fracture; Material Separation

  THE ACCOUNT ALLEGES THAT DURING A CAROTID STENT DEPLOYMENT PROCEDURE, THE CATHETER TIP DETACHED WITHIN THE PATIENT. THE PHYSICIAN HAD ACQUIRED RETROGRADE ARTERIAL ACCESS AND HAD NEGOTIATED THE PATIENT'S VASCULATURE SYSTEM WITH A GUIDEWIRE AND THE 5F CATHETER. DURING CATHETER MANIPULATIONS UNDER FLUOROSCOPY THE CATHETER TIP DETACHED AND STARTED TO MIGRATE TOWARDS THE SUBCLAVIAN AND HUMERAL ARTERIES. THE PHYSICIAN SUCCESSFULLY EXTERNALIZED THE FOREIGN BODIES LIBERATING THE NATIVE VESSELS. THE PATIENT TOLERATED THE PROCEDURE WELL WITH NO ADDITIONAL CONSEQUENCES TO REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17131159 ↗
• InjuryJun 14, 2023Fracture; Material Separation; Fracture; Material Separation

  THE ACCOUNT ALLEGES THAT DURING A CAROTID STENT DEPLOYMENT PROCEDURE, THE CATHETER TIP DETACHED WITHIN THE PATIENT. THE PHYSICIAN HAD ACQUIRED RETROGRADE ARTERIAL ACCESS AND HAD NEGOTIATED THE PATIENT'S VASCULATURE SYSTEM WITH A GUIDEWIRE AND THE 5F CATHETER. DURING CATHETER MANIPULATIONS UNDER FLUOROSCOPY THE CATHETER TIP DETACHED AND STARTED TO MIGRATE TOWARDS THE SUBCLAVIAN AND HUMERAL ARTERIES. THE PHYSICIAN SUCCESSFULLY EXTERNALIZED THE FOREIGN BODIES LIBERATING THE NATIVE VESSELS. THE PATIENT TOLERATED THE PROCEDURE WELL WITH NO ADDITIONAL CONSEQUENCES TO REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17131153 ↗
• InjuryJan 10, 2023Fracture; Material Separation; Fracture; Material Separation

  THE ACCOUNT ALLEGES THAT DURING A PROCEDURE, THE IMPRESS CATHETER BROKE INTO TWO PIECES WITHIN THE PATIENT ANATOMY. THE DETACHED PIECES WERE SUCCESSFULLY RETRIEVED USING A SNARE. NO ADDITIONAL PATIENT CONSEQUENCE TO REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16134810 ↗
• InjuryJan 3, 2023Fracture; Material Separation; Fracture; Material Separation

  THE ACCOUNT ALLEGES THAT DURING A PROCEDURE, THE IMPRESS CATHETER BROKE INTO TWO PIECES WITHIN THE PATIENT ANATOMY. THE DETACHED PIECES WERE SUCCESSFULLY RETRIEVED USING A SNARE. NO ADDITIONAL PATIENT CONSEQUENCE TO REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16092045 ↗
• InjuryJun 1, 2022Fracture; Material Separation; Fracture; Material Separation

  THE ACCOUNT ALLEGES THAT DURING A DIAGNOSTIC ENDOVASCULAR PROCEDURE, THE CATHETER HAD DETACHED TWICE WITHIN THE PATIENT. THE PHYSICIAN HAD ACQUIRED VASCULAR ACCESS AND DURING CATHETER MANIPULATIONS OVER A GUIDEWIRE, UNDER FLUOROSCOPY, THE CATHETER DETACHED. THE PHYSICIAN WAS ABLE TO SUCCESSFULLY EXTERNALIZE ONLY ONE FOREIGN BODY FROM THE PATIENT WITH A VASCULAR SNARE DEVICE. THE OTHER FOREIGN BODY THAT DETACHED BECAME STUCK WITHIN THE PATIENT'S LEG. NO ADDITIONAL PATIENT CONSEQUENCES TO REPORT.

  Patient problems: Foreign Body Embolism; Foreign Body In Patient; Ischemia; Obstruction/Occlusion

  MAUDE report 14570743 ↗