Impress® 00884450697375Recalls & reported problems
Merit Medical Systems, Inc. · Class 2
Data updated Oct 13, 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 00884450697375), received between Mar 11, 2026 and Mar 11, 2026 — 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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Material Separation2
Patient problems
- Foreign Body In Patient2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 11, 2026Material Separation
DURING A PERIPHERAL INTERVENTION WITH AN IMPRESS CATHETER, THE TIP BROKE OFF IN THE THORACIC AORTA. AS A RESULT, THE PATIENT WAS TAKEN FOR AN ADDITIONAL PROCEDURE TO SNARE THE BROKEN TIP WITH A RETRIEVAL BASKET.
Patient problems: Foreign Body In Patient
MAUDE report 24567691 ↗MalfunctionMar 11, 2026Material Separation
DURING A PERIPHERAL INTERVENTION WITH AN IMPRESS CATHETER, THE TIP BROKE OFF IN THE THORACIC AORTA. AS A RESULT, THE PATIENT WAS TAKEN FOR AN ADDITIONAL PROCEDURE TO SNARE THE BROKEN TIP WITH A RETRIEVAL BASKET.
Patient problems: Foreign Body In Patient
MAUDE report 24567690 ↗
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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 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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