Impress® 00884450029541Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00884450029541), received between Sep 10, 2021 and Mar 7, 2025 — classified as 4 injuries.

The most frequently reported specific device problem is “Fracture” (4 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryMar 7, 2025Fracture; Material Separation; Fracture; Material Separation

  THE ACCOUNT ALLEGES THAT AN EXPIRED PIGTAIL CATHETER WAS USED AND DETACHED DURING AN INVASIVE VASCULAR PROCEDURE. PARTIAL RETRIEVAL OF THE CATHETER WAS COMPLETED, BUT A FRAGMENT OF THE CATHETER REMAINS IN THE PERIPHERAL PART OF THE PATIENT. THE PROCEDURE WAS STENTING OF INGUINAL STENOSIS. PUNCTURE FROM THE LEFT INGUINAL REGION, INSERTION OF A GUIDEWIRE INTO THE PRODUCT AND MANIPULATION FOR CONTRAST AND DELIVERY INTO THE ABDOMINAL AORTA RESULTED IN THE PIGTAIL CATHETER DETACHMENT. AT PRESENT THE PATIENT IS OBSERVED WITHOUT SURGICAL REMOVAL OF THE REMAINED PART. THE PRODUCT IN QUESTION WAS FOUND TO HAVE ALREADY EXPIRED WHEN THE EVENT OCCURRED.

  Patient problems: Foreign Body In Patient

  MAUDE report 21549882 ↗
• InjuryApr 4, 2023Fracture; Material Separation; Fracture; Material Separation

  THE ACCOUNT ALLEGES THAT DURING AN ENDOVASCULAR AORTIC REPAIR [EVAR] PROCEDURE, THE CATHETER TIP DETACHED WITHIN THE PATIENT. THE PHYSICIAN HAD SUCCESSFULLY NAVIGATED THE ILIO-FEMORAL CONDUIT AND ACQUIRED BILATERAL FEMORAL ARTERY ACCESS. A GUIDEWIRE WAS THEN ADVANCED TO THE ANEURYSM SITE. DURING GUIDEWIRE MANIPULATIONS, THE PHYSICIAN NOTED THE CATHETER TIP WAS MISSING AND HAD MIGRATED TO THE PATIENT'S AORTIC BIFURCATION. THE FOREIGN BODY WAS SUCCESSFULLY EXTERNALIZED, LIBERATING THE VESSEL ALONG WITH ALL RESIDUAL INTERVENTIONAL EQUIPMENT. A COMPETITOR'S DEVICE WAS USED TO COMPLETE THE PROCEDURE FOR THIS PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16679188 ↗
• InjuryApr 4, 2023Fracture; Material Separation; Fracture; Material Separation

  THE ACCOUNT ALLEGES THAT DURING AN ENDOVASCULAR PROCEDURE, THE TIP DETACHED WITHIN THE PATIENT. THE FOREIGN BODY WAS SUCCESSFULLY EXTERNALIZED, LIBERATING THE VESSEL. NO ADDITIONAL PATIENT CONSEQUENCES TO REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16678968 ↗
• InjurySep 10, 2021Fracture; Material Separation; Fracture; Material Separation

  THE ACCOUNT ALLEGES THAT DURING A STENT-GRAFT PROCEDURE, THE SURGEON USED A STRAIGHT PROBE TO DO HIS RADIOLOGICAL CHECKS. THE DISTAL PART OF THE PROBE HAS COME LOOSE IN THE AORTA AND THE PHYSICIAN HAD TO USE A SNARE TO GET THE PIECE OUT OF THE PATIENT'S BODY.

  Patient problems: Foreign Body In Patient

  MAUDE report 12453655 ↗