Impress® 00884450712184Recalls & 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
- 6
- Deaths reported
- 0
- Injuries reported
- 3
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00884450712184), received between Nov 20, 2024 and May 22, 2025 — classified as 3 injuries, 3 malfunctions.
The most frequently reported specific device problem is “Fracture” (6 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
- Fracture6
- Material Separation6
Patient problems
- No Clinical Signs, Symptoms or Conditions6
Recent adverse event reports
The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.
InjuryMay 22, 2025Fracture; Material Separation; Fracture; Material Separation
THE ACCOUNT ALLEGES THE CATHETER BROKE AND DETACHED DURING USE WITHIN THE AORTIC ARCH. THE BROKEN PIECE WAS SUCCESSFULLY RETRIEVED. NO ADDITIONAL PATIENT CONSEQUENCE TO REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22072861 ↗MalfunctionDec 13, 2024Fracture; Material Separation; Fracture; Material Separation
THE ACCOUNT ALLEGES THAT A 4F CATHETER DETACHED WITHIN THE PATIENT. THE FOREIGN BODY WAS RETRIEVED FROM THE PATIENT. NO ADDITIONAL PATIENT CONSEQUENCES TO REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20922298 ↗MalfunctionDec 12, 2024Fracture; Material Separation; Fracture; Material Separation
THE ACCOUNT ALLEGES THAT A 4F CATHETER DETACHED WITHIN THE PATIENT. THE FOREIGN BODY WAS RETRIEVED FROM THE PATIENT. NO ADDITIONAL PATIENT CONSEQUENCES TO REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20921504 ↗MalfunctionDec 12, 2024Fracture; Material Separation; Fracture; Material Separation
THE ACCOUNT ALLEGES THAT A 4F CATHETER DETACHED WITHIN THE PATIENT. THE FOREIGN BODY WAS RETRIEVED FROM THE PATIENT. NO ADDITIONAL PATIENT CONSEQUENCES TO REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20919806 ↗InjuryNov 20, 2024Fracture; Material Separation; Fracture; Material Separation
THE ACCOUNT ALLEGES THAT A 4F CATHETER DETACHED WITHIN THE PATIENT. THE FOREIGN BODY WAS RETRIEVED FROM THE PATIENT WITH A VASCULAR SNARE DEVICE. NO ADDITIONAL PATIENT CONSEQUENCES TO REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20740905 ↗InjuryNov 20, 2024Fracture; Material Separation; Fracture; Material Separation
THE ACCOUNT ALLEGES THAT A 4F CATHETER DETACHED WITHIN THE PATIENT. THE FOREIGN BODY WAS RETRIEVED FROM THE PATIENT WITH A VASCULAR SNARE DEVICE. NO ADDITIONAL PATIENT CONSEQUENCES TO REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20740801 ↗
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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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