Impress® 00884450042526Recalls & 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
- 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 00884450042526), received between Jan 11, 2023 and Jan 11, 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 16, 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.
InjuryJan 11, 2023Fracture; Material Separation; Fracture; Material Separation
THE ACCOUNT ALLEGES WHILE PERFORMING A LEFT LEG ANGIOGRAPHY PROCEDURE, THE CLINICIAN ENTERED THROUGH THE RIGHT GROIN AND WENT UP AND OVER TO THE BIFURCATION AND DOWN THE LEFT LEG. THE CLINICIAN USED A STIFF GLIDE FROM TERUMO TO PLACE THE CATHETER AND THEN EXCHANGED WITH AN AMPLATZ WIRE. WHILE TRYING TO REMOVE THE CATHETER OVER THE WIRE, THE CATHETER TIP SEPARATED AND WITHIN THE PATIENT. THE FOREIGN BODY WAS SUCCESSFULLY RETRIEVED USING A SNARE. NO ADDITIONAL PATIENT CONSEQUENCE TO REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16137456 ↗
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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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