Impress® 00884450042557Recalls & 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
- 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 00884450042557), received between May 17, 2023 and May 17, 2023 — classified as 1 injury.
The most frequently reported specific device problem is “Fracture” (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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Most reported problems
Device problems
- Fracture1
- Material Fragmentation1
- Material Separation1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryMay 17, 2023Fracture; Material Fragmentation; Material Separation; Fracture; Material Fragmentation; Material Separation
THE ACCOUNT ALLEGES THAT DURING A UFE PROCEDURE, THE CATHETER TIP FRAGMENTED WITHIN THE PATIENT. THE PHYSICIAN HAD ACQUIRED RADIAL ACCESS AND HAD NEGOTIATED THE PATIENT'S ILIO-FEMORAL CONDUIT WITH A GUIDEWIRE AND THE 4F CATHETER. DURING OVER-THE-WIRE CATHETER MANIPULATIONS WITHIN THE PATIENT'S VASCULATURE SYSTEM THE TIP FRAGMENTED. THE PHYSICIAN USED A VASCULAR SNARE DEVICE TO SUCCESSFULLY EXTERNALIZE THE FRAGMENTED TIP LIBERATING THE VESSEL. NO ADDITIONAL PATIENT CONSEQUENCES TO REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16946559 ↗
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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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