Impress® 00884450042489Recalls & 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 00884450042489), received between Apr 22, 2020 and Apr 22, 2020 — 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
- Foreign Body In Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryApr 22, 2020Fracture; Material Separation; Fracture; Material Separation
THE ACCOUNT ALLEGES THAT DURING AN ANGIOGRAPHY POST-BRICKER'S PROCEDURE, NEOBLADDER PROCEDURE, THE TIP OF THE CATHETER DETACHED WITHIN THE NEONATAL PATIENT. THE PHYSICIAN HAD ACQUIRED VASCULAR ACCESS AND DURING CATHETER MANIPULATIONS OVER THE WIRE, THE CATHETER TIP DETACHED. SEVERAL UNSUCCESSFUL ATTEMPTS TO RETRIEVE THE FOREIGN BODY FROM THE PATIENT HAD BEEN TRIED. THE DECISION WAS MADE TO LEAVE THE FOREIGN BODY WITHIN THE PATIENT UNTIL IT COULD BE SURGICALLY REMOVED DURING A FOLLOW UP SURGERY SCHEDULED FOR THE PATIENT ON A LATER DATE.
Patient problems: Foreign Body In Patient
MAUDE report 9989049 ↗
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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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