Impress® 00884450024973Recalls & reported problems
Merit Medical Systems, Inc. · Class 2
Data updated Oct 13, 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 00884450024973), received between Sep 19, 2024 and Sep 19, 2024 — classified as 1 injury.
The most frequently reported specific device problem is “Detachment of Device or Device Component” (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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Detachment of Device or Device Component1
- Fracture1
- Material Fragmentation1
- 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.
InjurySep 19, 2024Fracture; Material Fragmentation; Material Separation; Detachment of Device or Device Component; Fracture; Material Fragmentation; Material Separation; Detachment of Device or Device Component
THE ACCOUNT ALLEGES THAT DURING A PROCEDURE, THE PATIENT UNDERWENT A CAROTID ARTERY ANGIOGRAPHY USING THE MAP ANGIOGRAPHIC CATHETER. DURING THE PROCEDURE, THE CATHETER DETACHED. THE SURGEON USED A VASCULAR RETRIEVAL DEVICE TO REMOVE THE BROKEN CATHETER, BUT IT FRACTURED AGAIN. THE VASCULAR SURGEON MANAGED TO MOVE THE BROKEN CATHETER FROM WITH THE PATIENT HOWEVER, SEVERAL SMALL SEGMENTS REMAINED IN THE DEEP FEMORAL ARTERY AND COULD NOT BE RETRIEVED. THE SURGERY LASTED FOUR HOURS. CONSIDERING THE PATIENT'S POOR CONDITION, THE SURGEON THE DECISION WAS MADE TO LEAVE THE IFB WITHIN THE PATIENT.
Patient problems: Foreign Body In Patient
MAUDE report 20258445 ↗
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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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