Impress® B (REF 59035IUACTMB-H)Recalls & 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
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00884450698365), received between Jun 25, 2024 and Apr 23, 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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Fracture2
- Material Separation1
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.
InjuryApr 23, 2025Fracture; Fracture
THE ACCOUNT ALLEGES THAT DURING THE PROCEDURE, THE TIP OF THE CATHETER BROKE AND HAD GONE TO THE POPLITEAL AND PERONEAL ARTERY. WHILE SNARING THE TIP, IT BROKE INTO SEVERAL PIECES. THROMBOLYSIS WAS NEEDED TO REMOVE THE CATHETER TIP FROM THE PERONEAL ARTERY.
Patient problems: Foreign Body In Patient
MAUDE report 21891997 ↗InjuryJun 25, 2024Fracture; Material Separation; Fracture; Material Separation
THE ACCOUNT ALLEGES THAT DURING THE PROCEDURE THE CATHETER FRACTURED WITHIN THE EXTERNAL ILIAC ARTERY. THE CLINICIAN COULD NOT RETRIEVE THE FOREIGN BODY. THE CLINICIAN WILL RETREIVE THE FOREIGN BODY IN A LATER PROCEDURE. NO ADDITIONAL PATIENT CONSEQUENCE TO REPORT.
Patient problems: Foreign Body In Patient
MAUDE report 19610914 ↗
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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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