Arcadia™ 00884450490891Recalls & reported problems
Merit Medical Systems, Inc. · Class 2
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00884450490891), received between Dec 15, 2021 and Dec 15, 2021 — classified as 1 malfunction.
The most frequently reported specific device problem is “Material Rupture” (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
- Material Rupture1
- 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.
MalfunctionDec 15, 2021Material Rupture; Material Separation; Material Rupture; Material Separation
THE ACCOUNT ALLEGES THAT DURING A VERTEBRAL AUGMENTATION, THE BALLOON RUPTURED WHILE INFLATING WITHIN THE SPINE. PART OF THE BALLOON WAS LEFT BEHIND AS FOREIGN BODY MATERIAL AS THE PHYSICIAN WAS NOT ABLE TO RETRIEVE. THE PHYSICIAN STATES THAT THE FOREIGN BODY WILL NOT MIGRATE AND THAT IT IS ACCEPTABLE TO LEAVE WITHIN THE PATIENT.
Patient problems: Foreign Body In Patient
MAUDE report 13015108 ↗
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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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