Impress® 00884450043325Recalls & reported problems
Merit Medical Systems, Inc. · Class 2
All models of Impress (145)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00884450043325), received between Apr 4, 2023 and Apr 4, 2023 — classified as 1 injury.
The most frequently reported specific device problem is “Fracture” (1 report).
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
Device problems
- Fracture1
- Material Separation1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryApr 4, 2023Fracture; Material Separation; Fracture; Material Separation
THE ACCOUNT ALLEGES THAT AT THE BEGINNING OF THE PROCEDURE, THE DOCTOR REQUESTED A PUNCTURE NEEDLE AND 5F INTRODUCER, LATER HE REQUESTED A HYDROPHILIC GUIDEWIRE AND A 5F CATHETER. AS IT WAS A FIBROID EMBOLIZATION, THE DOCTOR SUGGESTED USING A UAC CATHETER, BUT HE REJECTED IT. AFTER INTRODUCING THE 5F CATHETER INTO THE PATIENT, DURING ITS MANIPULATION BY THE DOCTOR, THE HYDROPHILIC TIP DISLODGED, THE DOCTOR REMOVED IT WITH AN ENDOVASCULAR LOOP, THE DOCTOR MANAGED TO REMOVE THE FRAGMENTS LODGED INSIDE THE PATIENT AND THE INTERVENTION ENDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16675271 ↗
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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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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