Impress® 00884450032558Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 00884450032558), received between Jan 13, 2021 and Oct 12, 2022 — classified as 8 injuries, 2 malfunctions.

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. 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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• InjuryOct 12, 2022Fracture; Material Separation; Fracture; Material Separation

  THE ACCOUNT ALLEGES THAT DURING A PROCEDURE, THE TIP OF THE CATHETER DETACHED WITHIN THE PATIENT. THE CLINICAN WAS ABLE TO SUCCESSFULLY REMOVE THE FOREIGN BODY USING A SNARE. NO ADDITIONAL PATIENT CONSEQUENCE TO REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15592262 ↗
• InjuryOct 12, 2022Fracture; Material Separation; Fracture; Material Separation

  THE ACCOUNT ALLEGES THAT DURING A PROCEDURE, THE TIP OF THE CATHETER DETACHED WITHIN THE PATIENT. THE CLINICAN ATTEMPTED TO SNARE THE FOREIGN BODY BUT WAS UNSUCCESSFUL AND THE FRACTURED PIECE BROKE INTO SEVERAL PIECES WITHIN THE PATIENT. THE CLINICIAN WAS UNABLE TO REMOVE THE MULTIPLE FOREIGN BODIES. NO ADDITIONAL PATIENT CONSEQUENCE TO REPORT.

  Patient problems: Foreign Body In Patient

  MAUDE report 15592252 ↗
• InjuryOct 12, 2022Fracture; Material Separation; Fracture; Material Separation

  THE ACCOUNT ALLEGES THAT DURING A PROCEDURE, THE TIP OF THE CATHETER DETACHED WITHIN THE PATIENT. THE CLINICAN WAS ABLE TO SUCCESSFULLY REMOVE THE FOREIGN BODY USING A SNARE. NO ADDITIONAL PATIENT CONSEQUENCE TO REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15592203 ↗
• MalfunctionJul 28, 2021Break

  DOCTOR WAS PERFORMING SURGERY, A SCHEDULED FENESTRATED ENDOVASCULAR AORTIC REPAIR (FEVAR), ON PATIENT. AT 1331, DOCTOR STATED THAT THE TIP OF THE 5F BERN CATHETER HAD BROKEN OFF IN THE PATIENT. THE BACK PORTION OF THE CATHETER WAS REMOVED. THE BROKEN CATHETER PIECE REMAINED ON THE WIRE AND DID NOT MOVE. DOCTOR WAS ABLE TO REMOVE ALL OF THE BROKEN PIECE USING A 10MM SNARE. RISK MANAGEMENT REQUESTED TO SEQUESTER DEVICE. DEVICE WILL BE GIVEN TO THEM AND THEY WILL PROVIDE MANUFACTURER WITH PICTURES OR ALLOW INSPECTION ON SITE IF REQUESTED.

  Patient problems: Foreign Body In Patient

  MAUDE report 12238108 ↗
• MalfunctionJul 20, 2021Fracture; Fracture

  THE ACCOUNT ALLEGES THAT DURING A BILIARY DRAINAGE PROCEDURE, THE 65CM IMPRESS CATHETER BROKE DURING INSERTION INTO THE PATIENT. NO PATIENT CONSEQUENCE TO REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12200013 ↗
• InjuryJun 30, 2021Fracture; Fracture

  THE ACCOUNT ALLEGES THAT DURING A BILIARY DRAINAGE CATHETER PLACEMENT PROCEDURE, A DIAGNOSTIC 5F CATHETER TIP DETACHED WITHIN THE PATIENT'S BILIARY DRAINAGE TUBE. NO MEDICAL INTERVENTION WAS NECESSARY. A NEW DEVICE WAS USED TO COMPLETE THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12092573 ↗
• InjuryJan 26, 2021Fracture; Material Separation; Fracture; Material Separation

  THE ACCOUNT ALLEGES THAT WHILE PREPPING A CATHETER FOR AN ANGIOGRAM PROCEDURE, THE CATHETER TIP DETACHED INTO SEVERAL PIECES ON THE TABLE. NO PATIENT INTERACTION. A NEW CATHETER WAS USED TO COMPLETE THIS PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11233364 ↗
• InjuryJan 26, 2021Fracture; Material Separation; Fracture; Material Separation

  THE ACCOUNT ALLEGES THAT DURING A PERCUTANEOUS TRANSLUMINAL ANGIOGRAM PROCEDURE, THE CATHETER TIP DETACHED WITHIN THE PATIENT. THE PHYSICIAN HAD ACQUIRED RETROGRADE ARTERIAL ACCESS AND HAD WAS NEGOTIATING THE PATIENT'S AORTA WHEN THE CATHETER TIP DETACHED. THE PHYSICIAN USED A VASCULAR SNARE DEVICE TO SUCCESSFULLY RETRIEVE THE FOREIGN BODY FROM THE PATIENT. NO ADDITIONAL INJURIES TO REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11233282 ↗
• InjuryJan 21, 2021Fracture; Material Separation; Fracture; Material Separation

  THE ACCOUNT ALLEGES THAT DURING A PROCEDURE WITHIN THE OPERATING ROOM, A PIECE OF THE CATHETER DETACHED WITHIN THE PATIENT. THE PHYSICIAN SUCCESSFULLY RETRIEVED THE FOREIGN BODY FROM THE PATIENT. NO PATIENT INJURY TO REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11211157 ↗
• InjuryJan 13, 2021Fracture; Material Separation; Fracture; Material Separation

  THE ACCOUNT ALLEGES THAT DURING AN ABDOMINAL AORTA ANEURISM [AAA] REPAIR PROCEDURE WITHIN THE INTERVENTIONAL RADIOLOGY/VASCULAR LAB, THE TIP OF THE DIAGNOSTIC CATHETER DETACHED WITHIN THE PATIENT. THE PHYSICIAN HAD SUCCESSFULLY ACQUIRED BILATERAL FEMORAL VASCULAR ACCESS AND THE CATHETER WAS ADVANCED OVER AN .035 GUIDEWIRE TO THE SITE OF INTEREST UNDER FLUOROSCOPY. DURING CATHETER MANIPULATIONS THE TIP DETACHED WITHIN THE PATIENTS DESCENDING AORTA. THE FOREIGN BODY WAS SUCCESSFULLY RETRIEVED. NO ADDITIONAL CONSEQUENCES TO REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11158894 ↗