Impress® 00884450038062Recalls & 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 00884450038062), received between Feb 21, 2023 and Feb 21, 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. How this data works · Data updated Oct 13, 2026.
Most reported problems
Device problems
- Fracture1
- 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.
InjuryFeb 21, 2023Fracture; Material Separation; Fracture; Material Separation
THE ACCOUNT ALLEGES THAT WHILE PERFORMING A DIALYSIS LINE INSERTION THEY ENCOUNTERED SOME DIFFICULTY ADVANCING DOWN THE INTERNAL JUGULAR VEIN. A 4FR SHEATH WAS INSERTED AND THE ANGIOGRAPHIC CATHETER AND A GLIDEWIRE WERE USED TO ACCESS THE SVC. A PIECE OF THE CATHETER HAD FRACTURED AND EMBOLIZED INTO THE LEFT PULMONARY ARTERY. THE CUSTOMER HAD TO PERFORM A SEPARATE PROCEDURE TO RETRIEVE SUCH PIECE WHICH WAS SUCCESSFUL.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16415036 ↗
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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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