Impress® 00884450012413Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00884450012413), received between Nov 30, 2021 and Jul 6, 2022 — classified as 2 injuries, 1 malfunction.

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.

• MalfunctionJul 6, 2022Fracture; Material Separation; Fracture; Material Separation

  THE ACCOUNT ALLEGES THAT DURING AN EMBOLIZATION PROCEDURE, THE CATHETER TIP DETACHED WITHIN THE PATIENT TIBIAL BRANCH ARTERY FEEDING AN AV FISTULA. THIS OCCURRED ON THE REINTRODUCTION OF A GLIDE WIRE INTO THE 4F CATHETER POST ANGIOGRAPHIC RUN-OFF - HAND INJECTION. THE CLINICIAN WAS UNSUCCESSFUL IN RETRIEVING THE FOREIGN BODY FROM THE VESSEL WITH A VASCULAR SNARE DEVICE. THE CLINICAL NOTED THAT FOREIGN BODY WAS LOCATED WITHIN A VESSEL INTENDED FOR EMBOLIZATION. THE FOREIGN BODY WOULD SIMPLY ASSIST IN OCCLUDING THE TARGETED VESSEL. IT WAS NOT NECESSARY TO REMOVE THE FOREIGN BODY. SEVERAL ADDITIONAL EMBOLIC PRODUCTS WERE DEPLOYED, BOTH PROXIMAL AND DISTAL TO THE FOREIGN BODY FRAGMENT SUCCESSFULLY COMPLETING THE INTENDED EMBOLIZATION PROCEDURE. NO ADDITIONAL PATIENT CONSEQUENCES TO REPORT.

  Patient problems: Foreign Body In Patient

  MAUDE report 14939939 ↗
• 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 12902302 ↗
• 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 12902165 ↗