Impress® C (REF 410038MPA1-H)Recalls & 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
- 3
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00884450787427), received between Dec 17, 2025 and Dec 17, 2025 — classified as 1 injury, 2 malfunctions.
The most frequently reported specific device problem is “Fracture” (3 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
- Fracture3
Patient problems
- Foreign Body In Patient3
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
InjuryDec 17, 2025Fracture; Fracture
ACCOUNT REPORTED AN 86 YO MALE PATIENT UNDERWENT LOWER LIMB ARTERIAL BALLOON ANGIOPLASTY AND ARTERIAL PLAQUE ROTATIONAL ATHERECTOMY. DURING FEMORAL ARTERY ANGIOGRAPHY, THE INTRAVASCULAR ANGIOGRAPHY CATHETER SUDDENLY BROKE. IT WAS IMMEDIATELY RETRIEVED WITH A SNARE DEVICE, AND ONE SECTION OF THE CATHETER WAS REMOVED. IT WAS DISCOVERED THAT THE REMAINING CATHETER INSIDE THE VESSEL WAS STILL FRACTURED. AFTER REPEATED RETRIEVAL ATTEMPTS, THE SURGERY WAS EVENTUALLY COMPLETED.
Patient problems: Foreign Body In Patient
MAUDE report 23830654 ↗MalfunctionDec 17, 2025Fracture; Fracture
ACCOUNT REPORT THAT DURING A PROCEDURE THE TIP OF THE CATHETER BECAME CAUGHT IN A PATIENT'S VESSEL AND STRETCHED. THE GUIDEWIRE SUBSEQUENTLY PENETRATED THROUGH THE TIP. LATER, THE TIP DETACHED AND WAS RETRIEVED USING A SNARE. NO REPORTED PATIENT INJURY.
Patient problems: Foreign Body In Patient
MAUDE report 23830629 ↗MalfunctionDec 17, 2025Fracture; Fracture
ACCOUNT REPORT THAT DURING A PROCEDURE THE TIP OF CATHETER BROKE OFF INSIDE THE PATIENT. THE TIP WAS RETRIEVED. NO SIGNIFICANT PRESSURE OR TORQUING WAS USED. NO REPORTED PATIENT INJURY.
Patient problems: Foreign Body In Patient
MAUDE report 23830628 ↗
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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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