Impress® 00884450661499Recalls & 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 00884450661499), received between Apr 22, 2025 and Apr 22, 2025 — 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.
Reports received per month
Most reported problems
Device problems
- Fracture1
- Material Separation1
Patient problems
- Foreign Body In Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryApr 22, 2025Fracture; Material Separation; Fracture; Material Separation
THE ACCOUNT ALLEGES THAT DURING AN ANGIOGRAPHIC / TACE PROCEDURE THE CATHETER FRAGMENTED INTO SEVERAL PIECES WITHIN THE PATIENT. THE PHYSICIAN USED A VASCULAR SNARE DEVICE IN AN ATTEMPT TO SUCCESSFULLY EXTERNALIZE THE FOREIGN BODY FRAGMENTS FROM WITHIN THE PATIENT'S VESSEL; HOWEVER, SOME FOREIGN BODY FRAGMENTS STILL REMAIN WITHIN THE PATIENT'S LEFT LOWER LIMB. THE PATIENT'S VESSEL REMAINED PATENT AT THE TIME. THE ACCOUNT ALLEGES THAT THE CATHETER HUB INFORMATION WAS DIFFERENT THAN WHAT WAS SHOWN ON THE OUTSIDE LABEL. THE CATHETER HUB READ 6.5 5F 0.035, IT SHOULD HAVE READ 6.5 5F 0.038.
Patient problems: Foreign Body In Patient
MAUDE report 21881751 ↗
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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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