Impress® 00884450020135Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 00884450020135), received between May 19, 2021 and May 14, 2025 — classified as 8 injuries, 1 malfunction.

The most frequently reported specific device problem is “Fracture” (9 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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• InjuryMay 14, 2025Break; Fracture; Material Integrity Problem; Break; Fracture; Material Integrity Problem

  THE ACCOUNT ALLEGES THAT THE TIP OF THE CATHETER DETACHED WITHIN THE PATIENT. IT IS UNKNOWN AS TO WHAT MEDICAL PROCEDURE WAS BEING PERFORMED IN THE OR AT THE TIME. THE DEVICE WAS INTRODUCED INTO THE PATIENTS' ANATOMY. THE FOREIGN BODY REMAINED ON THE GUIDE WIRE AFTER DETACHMENT AND WAS SUCCESSFULLY REMOVED ALONG WITH THE GUIDE WIRE. THE EVENT DID NOT NECESSITATE MEDICAL OR SURGICAL INTERVENTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22022213 ↗
• InjuryJun 13, 2023Fracture; Material Separation; Fracture; Material Separation

  THE ACCOUNT ALLEGES THAT AN AORTO-GRAM OF THE LEFT COMMON ILIAC/EXTERNAL ILIAC ARTERY WAS PERFORMED WHEN THE CATHETER TIP DETACHED. THE FOREIGN BODY WAS RETRIEVED SUCCESSFULLY WITH A VASCULAR SNARE DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17115177 ↗
• MalfunctionDec 20, 2022Fracture; Material Separation; Fracture; Material Separation

  THE ACCOUNT ALLEGES THAT DURING AN EMBOLIZATION PROCEDURE, THE CATHETER DETACHED WITHIN THE PATIENT. THE PHYSICIAN HAD ACQUIRED RETROGRADE FEMORAL ARTERY ACCESS AND HAD NEGOTIATED THE PATIENT'S ILIAC BIFURCATION WITH A GUIDEWIRE AND THE 4F CATHETER. DURING OVER-THE-WIRE CATHETER EXCHANGE ATTEMPT, WITHIN THE PATIENT'S TORTUOUS AND CALCIFIED LEFT INTERNAL ILIAC ARTERY THE CATHETER TIP DETACHED. THE TIP REMAINED ON THE GUIDEWIRE AND WAS SUCCESSFULLY REMOVED ALONG WITH THE CATHETER. ADDITIONAL MEDICAL INTERVENTION WAS NOT NECESSARY. THE PRIMARY PROCEDURE SITE WAS ABANDONED DUE TO SHEATH VESSEL TORTUOSITY AND CALCIFICATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16018695 ↗
• InjuryDec 20, 2022Fracture; Material Separation; Fracture; Material Separation

  THE ACCOUNT ALLEGES THAT DURING AN INTERVENTIONAL PERCUTANEOUS TRANSHEPATIC BILIARY DRAINAGE/STENTING PROCEDURE, THE 4F CATHETER TIP DETACHED WITHIN THE PATIENT WHEN THE PHYSICIAN WAS TRYING TO MANEUVER THE CATHETER ACROSS THE BILIARY ARTERY. THE FOREIGN BODY WAS LEFT BEHIND WITHIN THE PATIENT'S VASCULAR SYSTEM. THE PATIENT IS SCHEDULED FOR AN ADDITIONAL FOREIGN BODY REMOVAL PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16018561 ↗
• InjuryDec 1, 2022Fracture; Material Separation; Fracture; Material Separation

  THE ACCOUNT ALLEGES THAT DURING A PERIPHERAL VASCULAR INTERVENTION, A CATHETER TIP DETACHED WITHIN THE PATIENT. THE PHYSICIAN HAD ACQUIRED RETROGRADE FEMORAL ARTERY ACCESS AND HAD NEGOTIATED THE PATIENT'S ILIO-FEMORAL BIFURCATION WITH A GUIDEWIRE AND THE 4F CATHETER. DURING A GUIDEWIRE EXCHANGE ATTEMPT, THE 4F CATHETER TIP DETACHED IN THE PATIENT'S COMMON ILIAC ARTERY. THE PHYSICIAN SUCCESSFULLY RETRIEVED THE FOREIGN BODY FROM THE PATIENT'S ILIAC ARTERY. THE PATIENT TOLERATED THE PROCEDURE WELL. NO ADDITIONAL CONSEQUENCES TO REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15894724 ↗
• InjuryAug 17, 2022Fracture; Material Separation; Fracture; Material Separation

  THE ACCOUNT ALLEGES THAT DURING USE, THE CATHETER TIP DETACHED WITHIN THE PATIENT. THE DETACHED PIECE WAS SUCCESSFULLY REMOVED. NO ADDITIONAL PATIENT CONSEQUENCE TO REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15246762 ↗
• InjuryJun 23, 2021Fracture; Material Separation; Fracture; Material Separation

  THE ACCOUNT ALLEGES THE TIP OF THE CATHETER DETACHED DURING A PROCEDURE AND WAS SEEN DURING AN INTRA-OP X-RAY. THE TIP WAS SUCCESSFULLY RETRIEVED AND A FINAL X-RAY WAS PERFORMED TO CONFIRM COMPLETE REMOVAL OF THE PIECE. NO ADDITIONAL PATIENT CONSEQUENCES TO REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12051017 ↗
• InjuryJun 8, 2021Fracture; Material Separation; Fracture; Material Separation

  THE ACCOUNT ALLEGES THAT DURING EXCHANGE OF THE CATHETER FROM THE PATIENT, THE DISTAL 9.5 CM BROKE OFF WITHIN THE PATIENT. THE TIP OF THE CATHETER WAS RETRIEVED.

  Patient problems: Foreign Body In Patient

  MAUDE report 11962119 ↗
• InjuryMay 19, 2021Fracture; Material Separation; Fracture; Material Separation

  THE ACCOUNT ALLEGES THAT DURING A PERCUTANEOUS TRANSLUMINAL MEDICAL PROCEDURE, A 4F CATHETER DETACHED WITHIN THE PATIENT WHEN TRYING TO REMOVE THE CATHETER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11852455 ↗