Impress® 00884450020012Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00884450020012), received between Dec 10, 2020 and Jan 3, 2023 — classified as 6 injuries, 1 malfunction.

The most frequently reported specific device problem is “Fracture” (7 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 3, 2023Fracture; Material Separation; Fracture; Material Separation

  THE ACCOUNT ALLEGES THAT THE CATHETER WAS DIRECTED OVER THE HYDROPHILIC GUIDEWIRE AND AN EXCHANGE WAS MADE FOR AN AMPLATZ GUIDEWIRE. IN ATTEMPTING TO REMOVE THE CATHETER THE END OF IT SHEARED OFF AT THE BIFURCATION AND WAS LEFT ON THE GUIDEWIRE. A SNARE WAS DIRECTED OVER THE GUIDEWIRE AND ATTEMPTING TO ENGAGE THE END OF THE CATHETER SEGMENT. THIS WAS SUCCESSFULLY PULLED BACK A SHORT DISTANCE. AT THIS POINT A 6 FRENCH GUIDE CATHETER WAS DIRECTED OVER THE GUIDEWIRE AND OVER THE CATHETER REMNANT. THE GUIDE CATHETER, GUIDEWIRE AND CATHETER REMNANT WERE ALL REMOVED AS A SINGLE UNIT SUCCESSFULLY. NO INJURY TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16092065 ↗
• InjuryOct 20, 2022Fracture; Material Separation; Fracture; Material Separation

  THE ACCOUNT ALLEGES THAT DURING AN ANGIOGRAM PROCEDURE, THE CATHETER TIP DETACHED WITHIN THE PATIENT'S LOWER LEG. THE CLINICIAN SUCCESSFULLY REMOVED THE DETACHED PIECE USING A SNARE. NO ADDITIONAL PATIENT CONSEQUENCE TO REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15642695 ↗
• InjuryAug 9, 2022Fracture; Material Separation; Fracture; Material Separation

  THE ACCOUNT ALLEGES THAT DURING A VASCULAR PROCEDURE, THE CATHETER TIP DETACHED WITHIN THE PATIENT. THE PHYSICIAN USED A COUPLE OF VASCULAR SNARES TO SUCCESSFULLY EXTERNALIZE THE FOREIGN BODY LIBERATING THE VESSEL. NO ADDITIONAL PATIENT CONSEQUENCES TO REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15196288 ↗
• InjuryMar 15, 2022Fracture; Material Separation; Fracture; Material Separation

  THE ACCOUNT ALLEGES THAT DURING A PROCEDURE IN EL SALVADOR, THE TIP OF THE CATHETER CAME OFF. THE PROVIDER WAS NOT ABLE TO REMOVE THE DEVICE WITH A SNARE.

  Patient problems: Foreign Body In Patient

  MAUDE report 13771751 ↗
• InjuryFeb 15, 2022Fracture; Material Separation; Fracture; Material Separation

  THE ACCOUNT ALLEGES THAT WHILE NAVIGATING A COMPLEX LESION IN THE FEMORAL ARTERY, AN ATTEMPT WAS MADE TO SWITCH TO A LONGER SHEATH. UPON REMOVING THE CATHETER, RESISTANCE WAS FELT. THEY CONTINUED TO PULL AND THE CATHETER TIP DETACHED. A SNARE WAS USED TO REMOVE THE TIP AND THE PROCEDURE CONTINUED.

  Patient problems: Foreign Body In Patient

  MAUDE report 13536864 ↗
• InjuryDec 10, 2020Fracture; Material Separation; Fracture; Material Separation

  THE ACCOUNT ALLEGES THAT DURING A PERIPHERAL VASCULAR INTERVENTION, THE CATHETER TIP DETACHED WITHIN THE PATIENT. THE PHYSICIAN SUCCESSFULLY REMOVED THE FOREIGN BODY FROM THE PATIENT WITH NO ADDITIONAL CONSEQUENCES TO REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10985424 ↗
• InjuryDec 10, 2020Fracture; Material Separation; Fracture; Material Separation

  THE ACCOUNT ALLEGES THAT DURING A PERIPHERAL VASCULAR INTERVENTION THE CATHETER TIP DETACHED WITHIN THE PATIENT. THE PHYSICIAN HAD SUCCESSFULLY ACQUIRED RETROGRADE FEMORAL ARTERY ACCESS AND HAD NEGOTIATED THE PATIENT'S COMMON ILIAC BIFURCATION [UP & OVER TECH.] WITH AN INTERVENTIONAL GUIDE WIRE AND THE 4F CATHETER. DURING A GUIDE WIRE EXCHANGE, THE CATHETER TIP DETACHED WITHIN THE PATIENT'S LEFT SUPERFICIAL FEMORAL ARTERY [SFA]. THIS EVENT REQUIRED AN ADDITIONAL FOREIGN BODY RETRIEVAL PROCEDURE. THE PATIENT TOLERATED THE PROCEDURE WELL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10985422 ↗