Impress® 00884450009284Recalls & reported problems
Merit Medical Systems, Inc. · Class 2
All models of Impress (145)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 4
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00884450009284), received between Mar 9, 2022 and Oct 16, 2024 — classified as 2 injuries, 2 malfunctions.
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.
Reports received per month
Most reported problems
Device problems
- Fracture4
- Material Separation2
- Material Fragmentation1
Patient problems
- Foreign Body In Patient3
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
InjuryOct 16, 2024Fracture; Material Fragmentation; Fracture; Material Fragmentation
THE ACCOUNT ALLEGES THAT DURING THE PROCEDURE THE 5F SIM 1 CATHETER TIP FRAGMENTED DURING CATHETER MANIPULATIONS. THE FOREIGN BODIES WERE RETRIEVED FROM THE PATIENT. THERE ARE NO ADDITIONAL PATIENT CONSEQUENCES TO REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20465626 ↗MalfunctionJun 16, 2022Fracture; Material Separation; Fracture; Material Separation
A NOTIVISA WEBSITE Nº 2022.05.005309 REPORT ALLEGES THAT DURING A THORACOABDOMINAL AORTIC ENDOPROSTHESIS PROCEDURE, A CATHETER TIP DETACHED WITHIN THE PATIENT. NO ADDITIONAL INFORMATION HAS BEEN RECEIVED.
Patient problems: Foreign Body In Patient
MAUDE report 14713897 ↗MalfunctionJun 16, 2022Fracture; Material Separation; Fracture; Material Separation
A NOTIVISA WEBSITE Nº 2022.05.005309 REPORT ALLEGES THAT DURING A THORACOABDOMINAL AORTIC ENDOPROSTHESIS PROCEDURE, A CATHETER TIP DETACHED WITHIN THE PATIENT. NO ADDITIONAL INFORMATION HAS BEEN RECEIVED.
Patient problems: Foreign Body In Patient
MAUDE report 14713896 ↗InjuryMar 9, 2022Fracture; Fracture
THE ACCOUNT ALLEGES THAT DURING AN ENDOVASCULAR AORTIC REPAIR [EVAR] PROCEDURE, THE CATHETER TIP DETACHED WITHIN THE PATIENT. THE PHYSICIAN HAD SUCCESSFULLY NAVIGATED THE ILIO-FEMORAL CONDUIT AND ACQUIRED BILATERAL FEMORAL ARTERY ACCESS. DURING CATHETER MANIPULATIONS THE CATHETER TIP DETACHED. THE FOREIGN BODY REMAINS WITHIN THE PATIENT VESSEL AS THE PHYSICIAN COULD NOT REMOVE IT. NO ADDITIONAL PATIENT CONSEQUENCES TO REPORT.
Patient problems: Foreign Body In Patient
MAUDE report 13711208 ↗
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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