Impress® 00884450035887Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00884450035887), received between Aug 9, 2022 and Sep 19, 2023 — classified as 3 injuries.

The most frequently reported specific device problem is “Fracture” (3 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjurySep 19, 2023Fracture; Material Separation; Fracture; Material Separation

  THE ACCOUNT ALLEGES THAT DURING THE PROCEDURE THE DIAGNOSTIC CATHETER TIP BROKE OFF IN THE PROXIMAL CCA. AN ATTEMPT WAS MADE TO RETRIEVE THE TIP BY USING ANOTHER IMPRESS CATHETER WHICH RESULTED IN THE SECOND CATHETER ALSO BREAKING OFF INSIDE OF THE PATIENT. WHILE ATTEMPTING TO RETRIEVE ONE OF THE PIECES WITH A SNARE THE TIP MIGRATED TO THE SUPERIOR MESENTERIC ARTERY. A NON-FLOW LIMITED DISSECTION WAS OBSERVED. THE TIPS REMAINED INSIDE OF THE PATIENT. THE FIRST BEING LEFT IN THE LEFT DISTAL CCA THE OTHER IN THE SUPERIOR MESENTERIC ARTERY. THE PATIENT WAS REFERRED TO ANOTHER HOSPITAL WHERE SEVERAL MORE ATTEMPTS WERE MADE TO RETRIEVE THE BROKEN TIPS. NO ADDITIONAL PATIENT CONSEQUENCE TO REPORT.

  Patient problems: Foreign Body In Patient

  MAUDE report 17777808 ↗
• InjuryDec 8, 2022Fracture; Material Separation; Fracture; Material Separation

  THE ACCOUNT ALLEGES THAT DURING A LEFT COMMON CAROTID ARTERY [LCCA], THROMBECTOMY PROCEDURE, THE CATHETER TIP DETACHED WITHIN THE PATIENT. THE PHYSICIAN HAD ACQUIRED SUCCESSFUL VASCULAR ACCESS AND HAD PLACED A LONG SHEATH FOR EXTRA VASCULAR SUPPORT AND DELIVERABILITY TO THE PATIENTS LCCA VIA CO-AXIAL TECHNIQUE. AFTER SUCCESSFUL CATHETER PLACEMENT WITHIN THE LCCA THE 5F CATHETER TIP DETACHED. THE PHYSICIAN USED A NEUROVASCULAR CATHETER TO SUCCESSFULLY EXTERNALIZED PART OF THE FOREIGN BODY HOWEVER, THE FOREIGN BODY FRAGMENTED, AND A PIECE OF THE CATHETER REMAINS WITHIN THE PATIENT.

  Patient problems: Foreign Body In Patient

  MAUDE report 15941601 ↗
• InjuryAug 9, 2022Fracture; Material Separation; Fracture; Material Separation

  THE ACCOUNT ALLEGES THAT THE CATHETER BROKE INTO TWO PARTS INSIDE THE PATIENT DURING ENDOVASCULAR COIL ANEURYSM REPAIR. PATIENTS HAD TORTUOUS RIGHT EXTERNAL ILIAC ARTERIES. THE FOREIGN BODY WAS REMOVED FROM THIS PATIENT WITH A ENDOVASCULAR SNARE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15195711 ↗