Impress® 00884450009307Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00884450009307), received between Jul 8, 2021 and Mar 14, 2023 — classified as 6 injuries.

The most frequently reported specific device problem is “Fracture” (6 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• InjuryMar 14, 2023Fracture; Material Separation; Fracture; Material Separation

  THE ACCOUNT ALLEGES THAT DURING USE THE TIP OF THE ANGIOGRAPHCI CATHETER CRACKED WHILE IN THE PATIENT'S BODY. THE PHYSICIAN USED A SINGLE RING CAPURE DEVICE TO ATTEMPT REMOVAL BUT FAILED. ANOTHER PHYSICIAN ATTEMPTED TO REMOVE THE TIP OF THE CATHETER AND ALSO FAILED. OPEN VASCULAR SURGERY WAS PERFORMED TO REMOVE ALL RUPTURED PIECES OF THE DEVICE FROM THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16541599 ↗
• InjuryDec 6, 2022Fracture; Material Separation; Fracture; Material Separation

  THE ACCOUNT ALLEGES THAT DURING A TRA CEREBRAL ANGIOGRAPHY PROCEDURE, THE TIP OF THE CATHETER CRACKED INTO TWO PIECES. THE PIECES HAD TO BE REMOVED BY GENERAL SURGERY WITH THE PATIENT UNDER ANESTHESIA. NO ADDITIONAL INFORMATION AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15928427 ↗
• InjuryNov 29, 2022Fracture; Material Separation; Fracture; Material Separation

  THE ACCOUNT ALLEGES THAT DURING A DIAGNOSTIC PROCEDURE, A SMALL PIECE OF THE CATHETER DETACHED AND REMAINED IN THE CELIAC ARTERY. THE PHYSICIAN STOPPED THE PROCEDURE AND TRANSFERRED THE PATIENT TO THE ICU FOR CLOSE MONITORING. THE DETACHED PIECES OF THE CATHETER REMAIN WITHIN THE PATIENT. NO ADDITIONAL INFORMATION AVAILABLE.

  Patient problems: Foreign Body In Patient

  MAUDE report 15882892 ↗
• InjuryNov 29, 2022Fracture; Material Separation; Fracture; Material Separation

  THE ACCOUNT ALLEGES THAT DURING A DIAGNOSTIC PROCEDURE, A SMALL PIECE OF THE CATHETER DETACHED AND REMAINED IN THE CELIAC ARTERY. THE PHYSICIAN STOPPED THE PROCEDURE AND TRANSFERRED THE PATIENT TO THE ICU FOR CLOSE MONITORING. THE DETACHED PIECES OF THE CATHETER REMAIN WITHIN THE PATIENT. NO ADDITIONAL INFORMATION AVAILABLE.

  Patient problems: Foreign Body In Patient

  MAUDE report 15882862 ↗
• InjuryJul 20, 2021Fracture; Material Separation; Fracture; Material Separation

  THE ACCOUNT ALLEGES THAT DURING THE PROCEDURE THE TIP OF THE CATHETER BROKE INTO TWO SECTIONS. A SNARE WAS USED TO CAPTURE THE BROKEN TIP; HOWEVER, ONE PIECE WAS STILL IN THE PATIENT'S BODY. AN ADDITIONAL PROCEDURE WAS NEEDED TO REMOVE THE SECOND PIECE.

  Patient problems: Foreign Body In Patient

  MAUDE report 12199226 ↗
• InjuryJul 8, 2021Fracture; Material Fragmentation; Fracture; Material Fragmentation

  THE ACCOUNT ALLEGES DURING A PROCEDURE THE ANGIOGRAPHY TUBE BROKE INTO 2 SECTIONS. WHILE ATTEMPTING TO REMOVE THE FOREIGN BODIES THEY BROKE AGAIN FOR A TOTAL OF 4 PIECES. AN ADDITIONAL PROCEDURE WAS NECESSARY TO REPAIR DAMAGE TO THE PATIENT VASCULATURE AFTER REMOVAL OF THE PIECES. THERE IS NO FURTHER PATIENT CONSEQUENCE TO REPORT.

  Patient problems: Foreign Body In Patient

  MAUDE report 12134877 ↗