Impress® 00884450654538Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00884450654538), received between Jul 17, 2024 and Aug 27, 2025 — classified as 4 injuries, 1 malfunction.

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. 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.

• InjuryAug 27, 2025Break; Fracture; Material Integrity Problem; Break; Fracture; Material Integrity Problem

  THE ACCOUNT ALLEGES THAT DURING A VENOUS STENT PROCEDURE, THE CATHETER TIP DETACHED AND MIGRATED TO THE HEART. THIS OCCURRED DURING THE CROSS OVER TO ASSESS THE OPPOSITE SIDE OF THE PATIENT PRIOR TO PLACING THE STENT. THE PATIENT WAS ADMITTED TO THE HOSPITAL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22909979 ↗
• MalfunctionFeb 5, 2025Unable to Obtain Readings; Unable to Obtain Readings

  THE COMPLAINT ALLEGES THAT A PATIENT HAD REPEATED HIGH BLOOD PRESSURE MEASUREMENTS THAT COULD NOT BE CONFIRMED WITH NON-INVASIVE MEASUREMENT TECHNIQUES. THE DISCREPANCY WAS AS HIGH AS 80 MMHG. A SIDE COMPARISON WITH NON-INVASIVE MEASUREMENT RESULTED IN VALUES OF AROUND 120 MMHG SYSTOLIC. EXCHANGED THE SET AND THE VALUES NORMALIZED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21318387 ↗
• InjuryFeb 5, 2025Display or Visual Feedback Problem; Fracture; Unable to Obtain Readings; Display or Visual Feedback Problem; Fracture; Unable to Obtain Readings

  THE COMPLAINT ALLEGES THAT A PATIENT HAD MASSIVELY ELEVATED BLOOD PRESSURE WHILE LYING FOR A LONG TIME (>300 MMHG SYSTOLIC), ANTI HYPERTENSIVE MEDICATION WAS IMMEDIATELY ADMINISTERED AND A TRIP TO THE CT WAS NEEDED TO RULE OUT THE SUSPICION OF A CEREBRAL HEMORRHAGE. WHEN CHANGING THE BLOOD PRESSURE TRANSMISSION TO THE TRANSPORT MONITOR, THE CLINICAL TEAM NOTICED THAT A CONTACT WAS BROKEN. THE NURSING STAFF COULD NOT IDENTIFY THE CAUSE.

  Patient problems: High Blood Pressure/ Hypertension

  MAUDE report 21318386 ↗
• InjuryNov 14, 2024Fracture; Material Separation; Separation Problem; Fracture; Material Separation; Separation Problem

  THE ACCOUNT ALLEGES THAT A CATHETER TIP LIKELY DETACHED WITHIN A PATIENT DURING A SCHEDULED RIGHT LEG ANGIOGRAM/POSSIBLE ANGIOPLASTY ON (B)(6) 2024. DURING THIS PROCEDURE, THE PHYSICIAN ATTEMPTED TO ACCESS VIA THE RIGHT FEMORAL ARTERY HOWEVER, IT WAS NOTED THAT THE PATIENT HAD SEVERE CALCIFICATION WITHIN THE RIGHT COMMON FEMORAL ARTERY [CFA], SUPERFICIAL FEMORAL ARTERY [SFA], AND THE RIGHT EXTERNAL ILIAC ARTERY [EIA]. THE PHYSICIAN THEN ACQUIRED SECONDARY RETROGRADE LEFT FEMORAL ARTERY ACCESS WITH 6FX45CM SHEATH FOR EXTRA SUPPORT. THE CLINICIAN WAS SUCCESSFUL IN ADVANCING BOTH THE .035 GLIDEWIRE AND 5F CATHETER UNDER FLUOROSCOPY DURING THE RIGHT ILIO-FEMORAL ARTERY CROSSOVER- TECHNIQUE TO ACQUIRE ACCESS TO THE TARGETED RIGHT FEMORAL ARTERY. THE PROCEDURE WAS SUCCESSFULLY COMPLETED AT THIS TIME WITHOUT THE ATTENDING MEDICAL STAFF NOTICING THE ACCIDENTAL IATROGENIC FOREIGN BODY [IFB] INTRODUCTION. THE ANGIOGRAM AND ANGIOPLASTY WERE SUCCESSFULLY PERFORMED ON THE PATIENT'S RIGHT EIA, AND RIGHT SFA. THE PATIENT UNDERWENT A SECONDARY FEMORAL ARTERY ENDARTERECTOMY PROCEDURE ON (B)(6) 2024. THE ATTENDING MEDICAL STAFF NOTED THE IATROGENIC FOREIGN BODY [IFB] THAT WAS INADVERTENTLY LEFT WITH

  Patient problems: Foreign Body In Patient; Obstruction/Occlusion

  MAUDE report 20689679 ↗
• InjuryJul 17, 2024Fracture; Material Separation; Fracture; Material Separation

  THE ACCOUNT ALLEGES THAT DURING A FEMORO-POPLITEAL STENTING RECANALIZATION PROCEDURE VIA CROSS-OVER TECHNIQUE, WHEN ATTEMPTING TO REMOVE THE CATHETER THE PHYSICIAN NOTED THAT THE TIP OF THE PROBE HAD BECOME LOOSE AND REMAINED ON THE INTRA-ARTERIAL GUIDEWIRE. THE TIP OF THE CATHETER WAS RECOVERED USING A VASCULAR SNARE DEVICE. NO ADDITIONAL PATIENT CONSEQUENCES TO REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19760329 ↗