Impress® 00884450032534Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00884450032534), received between Sep 22, 2021 and Feb 13, 2024 — classified as 3 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Fracture” (5 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 13, 2024Fracture; Material Separation; Fracture; Material Separation

  THE ACCOUNT ALLEGES THAT DURING AN INTERVENTIONAL RADIOLOGY PROCEDURE, A 5F HH1 CATHETER TIP DETACHED WITHIN THE PATIENT'S AORTIC ARCH DURING CATHETER MANIPULATIONS UNDER FLUOROSCOPY. THE PHYSICIAN EXPORTED THE IFB BY IMPLEMENTING AN INTRAVASCULAR GUIDEWIRE CAPTURE TECHNIQUE. THE DEVICE IS NOT AVAILABLE FOR RETURN. NO ADDITIONAL PATIENT CONSEQUENCES TO REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18696671 ↗
• MalfunctionOct 18, 2023Fracture; Material Separation; Fracture; Material Separation

  THE ACCOUNT ALLEGES DURING A CAROTID ANGIOGRAPHY PROCEDURE, THE CATHETER BROKE WHILE STILL ON THE WIRE. THE DEVICE AND DETACHED PIECE WERE SUCCESSFULLY REMOVED FROM THE PATIENT. NO ADDITIONAL PATIENT CONSEQUENCE TO REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17958912 ↗
• InjuryNov 9, 2022Fracture; Material Separation; Fracture; Material Separation

  THE ACCOUNT ALLEGES THAT DURING A CEREBRAL THROMBECTOMY PROCEDURE TO REMOVE CLOT FROM AN ARTERY IN A PATIENT ACTIVELY EXPERIENCING A CEREBRAL VASCULAR STROKE (CVS), THE CATHETER TIP DETACHED NEAR THE PATIENT'S AORTA. THE PHYSICIAN ATTEMPTED TO EXTERNALIZED THE FOREIGN BODY WITH A VASCULAR SNARE DEVICE WHEN THE FOREIGN BODY FRAGMENTED IN TO SIX ADDITIONAL PIECES. NO FRAGMENTS MIGRATED INTO THE CEREBRAL VASCULATURE SYSTEM. ALL FRAGMENTS WERE LOCATED WITHIN THE PATIENT'S AORTA. THE PHYSICIAN ATTEMPTED TO TREAT THE PATIENT STROKE MEDICALLY BECAUSE ALL OPERATORS WERE ENGAGED IN RETRIEVAL OF THE FRAGMENTS FOR MORE THAN 4 HOURS. THE PHYSICIAN WAS UNABLE TO COMPLETE THE THROMBECTOMY PROCEDURE RESULTING IN A CEREBRAL INFARCTION FOR THE PATIENT. PATIENT WAS PLACED ON A VENTILATOR AS OPERATORS WERE NOT ABLE TO PERFORM THROMBECTOMY SUCCESSFULLY.

  Patient problems: Foreign Body In Patient; Stroke/CVA

  MAUDE report 15764789 ↗
• InjuryOct 6, 2021Fracture; Material Separation; Fracture; Material Separation

  THE ACCOUNT ALLEGES DURING A PROCEDURE THE TIP OF THE CATHETER BROKE WITHIN THE FISTULA OF THE PATIENT. THE PHYSICIAN SUCCESSFULLY USED A SNARE TO REMOVE THE DETACHED PIECE FROM THE PATIENT. NO PATIENT INJURY TO REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12584567 ↗
• MalfunctionSep 22, 2021Fracture; Material Separation; Fracture; Material Separation

  THE ACCOUNT ALLEGES THAT DURING A CHEMO EMBOLIZATION PROCEDURE, THE DEVICE FRACTURED INTO TWO PIECES. THE PROCEDURE WAS COMPLETED USING THE SAME DEVICE. THERE WAS NO PATIENT INJURY TO REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12513240 ↗