Impress® 00884450009420Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00884450009420), received between Jun 1, 2022 and Apr 16, 2024 — classified as 4 injuries, 2 malfunctions.

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.

• InjuryApr 16, 2024Fracture; Material Separation; Fracture; Material Separation

  THE ACCOUNT ALLEGES THAT DURING A VASCULAR PROCEDURE, IT WAS NOTED THAT THE TIP OF THE CATHETER DETACHED WITHIN THE PATIENTS BODY. A VASCULAR SNARE DEVICE WAS USED TO RETRIEVE THE FOREIGN BODY FROM THE PATIENT. NO ADDITIONAL PATIENT CONSEQUENCES TO REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19122052 ↗
• InjuryDec 13, 2022Fracture; Material Separation; Fracture; Material Separation

  THE ACCOUNT ALLEGES THAT WHILE USING AN ANGIOGRAPHY CATHETER, THE DISTAL END OF THE CATHETER BROKE IN THE PATIENT'S ABDOMINAL AREA. WHILE TRYING TO RETRIEVE IT WITH A 6FR, THE CATHETER TIP BROKE INTO 5 OR 6 PIECES WHICH WENT INTO THE ARTERIAL CIRCULATION. THE PATIENT IS ADMITTED TO INTENSIVE CARE.

  Patient problems: Foreign Body In Patient

  MAUDE report 15973937 ↗
• InjuryJul 13, 2022Fracture; Material Separation; Fracture; Material Separation

  THE ACCOUNT ALLEGES THAT DURING A VASCULAR ANGIOGRAM PROCEDURE THE CATHETER TIP DETACHED. THE PHYSICIAN HAD ACQUIRED RETROGRADE FEMORAL ARTERY ACCESS AND HAD NEGOTIATED THE PATIENT'S AORTA WITH A GUIDEWIRE AND THE 5F CATHETER. DURING CATHETER MANIPULATIONS WITHIN THE PATIENT'S ABDOMINAL AORTA THE TIP DETACHED AND MIGRATED INTO THE ILIAC BIFURCATION. 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 CONSEQUENCES TO REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15009158 ↗
• InjuryJul 13, 2022Fracture; Material Separation; Fracture; Material Separation

  THE ACCOUNT ALLEGES THAT DURING A TACE PROCEDURE, THE 5F CATHETER DETACHED WITHIN THE PATIENT. THE PHYSICIAN HAD ACQUIRED RETROGRADE ARTERIAL ACCESS AND DURING CATHETER MANIPULATIONS OVER A GUIDEWIRE, UNDER FLUOROSCOPY THE TIP OF THE CATHETER DETACHED WITHIN THE PATIENT ILIAC ARTERY. THE PHYSICIAN ATTEMPTED TO USE A VASCULAR SNARE DEVICE TO EXTERNALIZED THE FOREIGN BODY BUT WAS UNSUCCESSFUL. AFTER CAPTURING THE FOREIGN BODY WITH A VASCULAR SNARE DEVICE, THE FOREIGN BODY FRAGMENTED INTO TWO ADDITIONAL PIECES AND MIGRATED TO THE PATIENT'S LUMBAR ARTERY AND INTERNAL ILIAC ARTERY. AFTER CLINICAL EVALUATION BY EXPERTS AND DOCTORS, IT WAS DECIDED TO LEAVE THE FOREIGN BODIES WITHIN THE PATIENT.

  Patient problems: Foreign Body In Patient

  MAUDE report 15008980 ↗
• MalfunctionJun 1, 2022Fracture; Material Separation; Fracture; Material Separation

  THE ACCOUNT ALLEGES THAT DURING A VASCULAR PROSTHESIS PROCEDURE THE CATHETER TIP CRACKED AND DETACHED WITHIN THE LEFT ILIAC ARTERY FOLLOWING INSERTION. RETRIEVAL OF THE FOREIGN BODY WAS ATTEMPTED USING THE RIGHT FEMORAL ARTERY, BUT WAS UNSUCCESSFUL. THE FOREIGN BODY WAS COVERED BY THE LEG OF THE ABDOMINAL AORTA COATED STENT AND IT WAS DECIDED AN ADDITIONAL RETRIEVAL PROCEDURE WAS NOT NEEDED. NO ADDITIONAL PATIENT CONSEQUENCE TO REPORT.

  Patient problems: Foreign Body In Patient

  MAUDE report 14569881 ↗
• MalfunctionJun 1, 2022Fracture; Material Separation; Fracture; Material Separation

  THE ACCOUNT ALLEGES THAT DURING A VASCULAR PROSTHESIS PROCEDURE THE CATHETER TIP CRACKED AND DETACHED WITHIN THE RIGHT FEMORAL ARTERY. THE CLINICIAN USED A ONE RING CAPTURE DEVICE TO PULL THE FOREIGN BODY OUT OF THE PATIENT SUCCESSFULLY. NO ADDITIONAL PATIENT CONSEQUENCE TO REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14569847 ↗