Impress® 00884450038109Recalls & reported problems

Summary

The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 00884450038109), received between Mar 12, 2020 and Oct 28, 2025 — classified as 10 injuries, 5 malfunctions.

The most frequently reported specific device problem is “Fracture” (14 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 18, 2026.

Most reported problems

Recent adverse event reports

The 15 most recent of 15 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 28, 2025Material Separation; Material Separation

  DURING AN UP AND OVER ANGIOGRAM OF LOWER LIMBS, THE CATHETER SEPARATED. THE PHYSICIAN WAS ABLE TO REMOVE THE DISTAL SEGMENT (CONSIDERED A FOREIGN BODY) AS IT REMAINED ON THE WIRE. NO REPORTED INJURY AS THEY WERE ABLE TO UPGRADE THE SHEATH AN WITHDRAW INTO A 7FR SHEATH.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23405570 ↗
• InjuryNov 28, 2023Fracture; Material Separation; Fracture; Material Separation

  THE ACCOUNT ALLEGES THAT DURING A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY PROCEDURE [PTA], THE 4F CATHETER TIP DETACHED WITHIN THE PATIENT. THE PHYSICIAN HAD ACQUIRED RETROGRADE RIGHT FEMORAL ARTERY ACCESS AND HAD NEGOTIATED THE PATIENT'S ILIO-FEMORAL CONDUIT WITH A SUPER STIFF .035 GUIDEWIRE AND 4F CATHETER. DURING OVER-THE-WIRE CATHETER MANIPULATIONS UNDER FLUOROSCOPY WITHIN THE PATIENT'S COMMON ILIAC ARTERY, THE CATHETER TIP DETACHED. THE CLINICIAN ACQUIRED BILATERAL FEMORAL ACCESS AND SUCCESSFULLY USED A VASCULAR SNARE DEVICE TO EXTERNALIZE THE FOREIGN BODY FROM THE PATIENT LIBERATING THE ILIAC VESSEL. AN ADDITIONAL CATHETER WAS USED TO COMPLETE THIS PROCEDURE. THE PATIENT WAS TRANSFERRED POST-PROCEDURE TO ICU FOR OBSERVATION. PROLONGATION OF HOSPITALIZATION WAS REQUIRED. THE PATIENT TOLERATED THE PROCEDURE WELL WITH NO ADDITIONAL CONSEQUENCES TO REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18222055 ↗
• MalfunctionNov 28, 2023Fracture; Material Separation; Fracture; Material Separation

  THE ACCOUNT ALLEGES THAT DURING A PERIPHERAL VASCULAR PROCEDURE, THE CATHETER TIP DETACHED WITHIN THE PATIENT AND WAS SUCCESSFULLY RETRIEVED. A GOOD FAITH EFFORT TO COLLECT ADDITIONAL INFORMATION REGARDING THIS EVENT HAS BEEN SUCCESSFULLY COMPLETED IN A TIMELY MANNER. NO ADDITIONAL INFORMATION ABOUT THIS EVENT HAS BEEN PROVIDED BY THIS ACCOUNT TO THE MANUFACTURER. A SUPPLEMENTAL REPORT WILL BE SUBMITTED IF ADDITIONAL INFO IS RECEIVED. THE SUSPECT DEVICE IS EXPECTED TO RETURN FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18222054 ↗
• InjuryMay 30, 2023Fracture; Material Separation; Fracture; Material Separation

  THE ACCOUNT ALLEGES THAT DURING A LEFT LEG ANGIOGRAM, VIA RIGHT FEMORAL PUNCTURE, THE CATHETER FRACTURED WITH THE DISTAL TIP REMAINING IN THE PATIENT AT THE AORTIC BIFURCATION. THE CATHETER TIP WAS RETRIEVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17027440 ↗
• InjuryApr 12, 2023Fracture; Material Separation; Fracture; Material Separation

  THE ACCOUNT ALLEGES THAT THE TIP OF THE CATHETER DETACHED WITHIN THE COMMON FEMORAL. THE PHYSICIAN ATTEMPTED TO RETRIEVE IT WITH A SNARE BUT WAS UNABLE TO REMOVE THE DETACHED TIP. A STENT WAS PLACED TO HOLD THE DETACHED TIP IN PLACE WITHIN THE PATIENT'S BODY.

  Patient problems: Foreign Body In Patient

  MAUDE report 16724117 ↗
• MalfunctionOct 13, 2022Fracture; Material Separation; Fracture; Material Separation

  THE ACCOUNT ALLEGES THAT DURING A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY OF A PATIENTS SUPERFICIAL FEMORAL ARTERY [SFA] A CATHETER TIP DETACHED. THE PHYSICIAN HAD ACQUIRED RETROGRADE, ARTERIAL ACCESS AND HAD NEGOTIATED THE PATIENT'S ILIO-FEMORAL CONDUIT UNDER FLUOROSCOPY WITH A GUIDEWIRE AND THE 4F CATHETER. DURING OVER-THE-WIRE CATHETER MANIPULATIONS, THE CATHETER TIP DETACHED BUT REMAINED ON THE GUIDEWIRE. THE PROCEDURE WAS DELAYED. A VASCULAR SNARE DEVICE WAS USED TO PIN THE DETACHED TIP TO THE WIRE DURING REMOVAL. THE ANGIOPLASTY PROCEDURE WAS COMPLETED POST FOREIGN BODY REMOVAL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15599084 ↗
• InjuryMay 11, 2022Fracture; Material Separation; Fracture; Material Separation

  THE ACCOUNT ALLEGES THAT DURING THE PROCEDURE THE TIP OF THE DEVICE DETACHED. NO ADDITIONAL PATIENT CONSEQUENCE TO REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14366241 ↗
• MalfunctionSep 29, 2021Fracture; Material Separation; Fracture; Material Separation

  THE ACCOUNT ALLEGES THAT DURING A PERIPHERAL VASCULAR PROCEDURE THE PHYSICIAN HAD ACQUIRED RETROGRADE FEMORAL ARTERY ACCESS. WHILE RETRIEVING THE CATHETER OVER THE GUIDEWIRE THE CATHETER TIP DETACHED. THE CATHETER TIP WAS RETRIEVED AS THE CATHETER TIP REMAINED ON THE GUIDEWIRE AND WAS REMOVED TOGETHER WITH THE GUIDEWIRE. NO ADDITIONAL CONSEQUENCES OR INTERVENTIONS WERE DEEMED NECESSARY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12548806 ↗
• InjuryApr 14, 2021Fracture; Material Separation; Fracture; Material Separation

  THE ACCOUNT ALLEGES THAT DURING A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY [PTA] PROCEDURE, THE CATHETER TIP DETACHED WITHIN THE PATIENT. THE PHYSICIAN HAD ACQUIRED RIGHT RETROGRADE FEMORAL ARTERY ACCESS AND HAD NEGOTIATED THE PATIENT'S COMMON ILIAC BIFURCATION WITH A GUIDEWIRE AND THE 4F CATHETER. DURING CATHETER MANIPULATIONS OVER THE WIRE WITHIN THE PATIENT'S ARTERY, THE CATHETER TIP DETACHED. THE PHYSICIAN USED A VASCULAR STENT TO PIN THE FOREIGN BODY IN PLACE TO PREVENT POSSIBLE MIGRATION. THE PATIENT TOLERATED THE PROCEDURE WELL WITH NO ADDITIONAL CONSEQUENCES TO REPORT.

  Patient problems: Foreign Body In Patient

  MAUDE report 11667617 ↗
• InjuryMar 24, 2021Fracture; Difficult to Remove; Material Separation; Fracture; Difficult to Remove; Material Separation

  THE ACCOUNT ALLEGES THAT DURING A PERIPHERAL VASCULAR PROCEDURE, THE CATHETER TIP DETACHED WITHIN THE PATIENT. THE PHYSICIAN HAD SUCCESSFULLY ACQUIRED RETROGRADE ARTERIAL ACCESS AND WHILE REMOVING THE CATHETER OVER A GUIDE WIRE, UNDER FLUOROSCOPY THE CATHETER TIP DETACHED. THE FOREIGN BODY WAS SUCCESSFULLY REMOVED WITH A VASCULAR SNARE DEVICE. NO ADDITIONAL CONSEQUENCES TO REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11562428 ↗
• InjuryNov 24, 2020Fracture; Material Separation; Fracture; Material Separation

  THE ACCOUNT ALLEGES THAT DURING A PERIPHERAL VASCULAR PROCEDURE, THE CATHETER TIP DETACHED WITHIN THE PATIENT. THE PHYSICIAN HAD SUCCESSFULLY ACQUIRED RETROGRADE ARTERIAL ACCESS AND DURING CATHETER MANIPULATIONS WITH THE 4F CATHETER, THE TIP OF THE CATHETER DETACHED WITHIN THE PATIENT'S FEMORAL ARTERY. THE PHYSICIAN THEN SUCCESSFULLY REMOVED THE DETACHED TIP WITH A VASCULAR SNARE DEVICE. THE PATIENT TOLERATED THE PROCEDURE WELL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10896528 ↗
• InjuryNov 24, 2020Fracture; Material Separation; Fracture; Material Separation

  THE ACCOUNT ALLEGES THAT DURING A PERIPHERAL VASCULAR PROCEDURE, THE CATHETER TIP DETACHED WITHIN THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10896469 ↗
• MalfunctionOct 27, 2020Fracture; Detachment of Device or Device Component; Fracture; Detachment of Device or Device Component

  THE ACCOUNT ALLEGES THAT DURING A PERCUTANEOUS TRANSLUMINAL INTERVENTION ON A PATIENT'S RIGHT SFA, THE CATHETER TIP DETACHED. THE PHYSICIAN HAD ACQUIRED RIGHT IPSILATERAL RETROGRADE FEMORAL ARTERY ACCESS AND HAD NEGOTIATED THE PATIENT'S COMMON ILIAC BIFURCATION OVER A GUIDEWIRE WITH THE 4F CATHETER. DURING CATHETER REMOVAL FROM THE CONTRALATERAL LEFT SFA, THE CATHETER TIP DETACHED WITHIN THE PATIENTS RIGHT COMMON ILIAC ARTERY. TO KEEP THE FOREIGN BODY FROM MIGRATING FURTHER INTO THE PATIENT'S PERIPHERY, THE PHYSICIAN DEPLOYED A VASCULAR STENT WITHIN THE ILIAC ARTERY TO SUCCESSFULLY PIN THE FOREIGN BODY IN PLACE. THE PATIENT TOLERATED THE PROCEDURE WELL.

  Patient problems: Foreign Body In Patient

  MAUDE report 10741792 ↗
• InjuryMay 28, 2020Fracture; Material Separation; Fracture; Material Separation

  THE ACCOUNT ALLEGES THAT DURING A VASCULAR PROCEDURE, THE CATHETER TIP DETACHED WITHIN A PATIENT. SURGICAL RETRIEVAL OF THE FOREIGN OBJECT WAS SUCCESSFUL.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10096988 ↗
• InjuryMar 12, 2020Fracture; Material Separation; Fracture; Material Separation

  THE ACCOUNT ALLEGES THAT DURING A VASCULAR PROCEDURE, THE CATHETER TIP DETACHED WITHIN A PATIENT. THE PHYSICIAN HAD ACQUIRED ARTERIAL VASCULAR ACCESS AND DURING CATHETER MANIPULATIONS THE TIP DETACHED WITHIN THE PATIENT'S COMMON FEMORAL ARTERY. THE PHYSICIAN USED A VASCULAR SNARE TO SUCCESSFULLY RETRIEVE THE CATHETER TIP FROM THE PATIENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9826400 ↗