Impress® 00884450009390Recalls & 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
- 3
- Deaths reported
- 0
- Injuries reported
- 3
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00884450009390), received between Aug 9, 2022 and Jun 14, 2023 — classified as 3 injuries.
The most frequently reported specific device problem is “Fracture” (3 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
Device problems
- Fracture3
- Material Separation3
Patient problems
- No Clinical Signs, Symptoms or Conditions3
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
InjuryJun 14, 2023Fracture; Material Separation; Fracture; Material Separation
THE ACCOUNT ALLEGES THAT WHILE ATTEMPTING TO SHAPE THE CATHETER OVER THE WIRE IN THE AORTA, THE TIP OF THE CATHETER BROKE OFF WITHIN THE PATIENT. THE FOREIGN BODY DID NOT MIGRATE AWAY FROM THE AORTA AND WAS SUCCESSFULLY RETRIEVED USING A SNARE. NO ADDITIONAL PATIENT CONSEQUENCE TO REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17130239 ↗InjuryJun 14, 2023Fracture; Material Separation; Fracture; Material Separation
THE ACCOUNT ALLEGES THAT WHILE ATTEMPTING TO SHAPE THE CATHETER OVER THE WIRE IN THE AORTA, THE TIP OF THE CATHETER BROKE OFF WITHIN THE PATIENT. THE FOREIGN BODY DID NOT MIGRATE AWAY FROM THE AORTA AND WAS SUCCESSFULLY RETRIEVED USING A SNARE. NO ADDITIONAL PATIENT CONSEQUENCE TO REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17129188 ↗InjuryAug 9, 2022Fracture; Material Separation; Fracture; Material Separation
THE ACCOUNT ALLEGES THAT THE CATHETER BROKE INTO TWO PARTS INSIDE THE PATIENT DURING ENDOVASCULAR COIL ANEURYSM REPAIR. PATIENTS HAD TORTUOUS RIGHT EXTERNAL ILIAC ARTERIES. THE FOREIGN BODY WAS REMOVED FROM THIS PATIENT WITH A ENDOVASCULAR SNARE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15195709 ↗
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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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