Impress® 00884450035900Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00884450035900), received between Mar 17, 2022 and Mar 18, 2022 — classified as 2 injuries.

The most frequently reported specific device problem is “Fracture” (2 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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryMar 18, 2022Fracture; Material Separation; Fracture; Material Separation

  THE ACCOUNT ALLEGES THAT DURING A PTCA PROCEDURE OF THE PATIENTS RIGHT INTERNAL MAMMARY GRAFT, THE CATHETER TIP DETACHED WITHIN THE PATIENT. THE PHYSICIAN WAS ABLE TO SUCCESSFULLY EXTERNALIZED THE FOREIGN BODY FROM THE PATIENT LIBERATING THE VESSEL. NO ADDITIONAL PATIENT CONSEQUENCES TO REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13804782 ↗
• InjuryMar 17, 2022Fracture; Material Separation; Fracture; Material Separation

  THE ACCOUNT ALLEGES THAT DURING A CAROTID ARTERIOGRAM PROCEDURE THE TIP OF THE DIAGNOSTIC 5F CATHETER DETACHED WITHIN THE PATIENT. THE PHYSICIAN HAD SUCCESSFULLY ACQUIRED RETROGRADE FEMORAL ARTERY ACCESS AND HAD NEGOTIATED THE PATIENT'S ILIO-FEMORAL CONDUIT UNDER FLUOROSCOPY TO SUCCESSFULLY CANNULATE THE TARGETED OSTIUM. DURING CATHETER MANIPULATIONS OVER A GUIDEWIRE, THE TIP OF THE CATHETER DETACHED WITHIN THE PATIENT'S RIGHT ILIAC CONDUIT. THE PHYSICIAN THEN SUCCESSFULLY EXTERNALIZED THE FOREIGN BODY WITH A VASCULAR SNARE DEVICE THUS LIBERATING THE VESSEL. A NEW DEVICE WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE FOR THE PATIENT WITH NO ADDITIONAL CONSEQUENCES TO REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13802963 ↗