Impress® 00884450683750Recalls & 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
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00884450683750), received between Oct 16, 2024 and Apr 22, 2025 — classified as 2 injuries.
The most frequently reported specific device problem is “Fracture” (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.
Reports received per month
Most reported problems
Device problems
- Fracture2
- Material Separation2
Patient problems
- Foreign Body In Patient1
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 2 most recent of 2 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 A CAROTID ARTERY STENTING PROCEDURE, THE CATHETER TIP DETACHED FROM ITS SHAFT AND MIGRATED FURTHER INTO THE CAROTID ARTERY. A VASCULAR SNARE DEVICE WAS USED TO CAPTURE THE DETACHED PORTION FOR REMOVAL. THE FOREIGN BODY FRAGMENTED INTO SMALLER PIECES. THE PHYSICIAN DECIDED TO SECURE THE DETACHED FRAGMENTS, WHICH MENT MOVING TOWARDS THE CEREBRAL PART. THE FOREIGN BODY WAS PINNED IN POSITION WITH A STENT. CURRENTLY PATIENT IS UNDER ICU OBSERVATION FOR STROKE RISK.
Patient problems: Foreign Body In Patient
MAUDE report 21886844 ↗InjuryOct 16, 2024Fracture; Material Separation; Fracture; Material Separation
THE ACCOUNT ALLEGES THAT DURING THE USE OF AN HH1 CATHETER THE IR PHYSICIAN TRIED TO COMPLETE AN ANGIOGRAM FOR POSSIBLE INTERVENTION. DURING CATHETER MANIPULATION, THE CATHETER TIP DETACHED WITHIN THE PATIENT'S CAROTID ARTERY. RETRIEVAL OF THE IFB WAS COMPLETED WITH THE USE OF A VASCULAR SNARE DEVICE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20467118 ↗
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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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