Impress® 00884450035894Recalls & 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
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00884450035894), received between Aug 24, 2021 and Jan 19, 2022 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Material Separation” (2 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
Device problems
- Material Separation2
Patient problems
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionJan 19, 2022Material Separation; Material Separation
THE ACCOUNT ALLEGES THAT DURING A BALLOON-OCCLUDED RETROGRADE TRANSVENOUS OBLITERATION (BRTO) PROCEDURE, FOR THE TREATMENT OF GASTRIC VARICES, THE DIAGNOSTIC CATHETER TIP DETACHED. NO MEDICAL OR SURGICAL INTERVENTION WAS NECESSARY FOR REMOVAL OF THE DETACHED TIP. THE TIP REMAINED ON THE GUIDEWIRE AND WAS REMOVED TOGETHER FROM THE PATIENT. NO ADDITIONAL CONSEQUENCES TO REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13289960 ↗MalfunctionAug 24, 2021Material Separation; Material Separation
THE ACCOUNT ALLEGES THAT DURING A BALLOON-OCCLUDED RETROGRADE TRANSVENOUS OBLITERATION (BRTO) PROCEDURE, FOR THE TREATMENT OF GASTRIC VARICES, THE DIAGNOSTIC CATHETER TIP DETACHED. NO MEDICAL OR SURGICAL INTERVENTION WAS NECESSARY FOR REMOVAL OF THE DETACHED TIP. THE TIP REMAINED ON THE GUIDEWIRE AND WAS REMOVED TOGETHER FROM THE PATIENT. NO ADDITIONAL CONSEQUENCES TO REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12363246 ↗
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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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