Arcadia™ GRecalls & 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 00884450815489), received between Jul 16, 2025 and Jul 16, 2025 — classified as 1 malfunction.
The most frequently reported specific device problem is “Break” (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.
Reports received per month
Most reported problems
Device problems
- Break1
- Fracture1
- Material Integrity Problem1
- 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.
MalfunctionJul 16, 2025Break; Fracture; Material Separation; Material Integrity Problem; Break; Fracture; Material Separation; Material Integrity Problem
THE ACCOUNT ALLEGES THAT THE KYPHOPLASTY BALLOONS WERE DEPLOYED INTO THE VERTEBRAL BODIES OF THE T12 VERTEBRA UNDER FLUOROSCOPIC GUIDANCE AND SATISFACTORY BALLOON FILL WAS NOTED AT EACH LEVEL BILATERALLY. ON THE RIGHT SIDE, DURING BALLOON INFLATION, THE BALLOON RUPTURED DESPITE NO PRESSURE OVER 400MHG. DURING REMOVAL OF THE BALLOON, THE SMALL PLATINUM-IRIDIUM MARKER WAS RETAINED WITHIN THE VERTEBRAL BODY. AN INTRAOPERATIVE DECISION WAS MADE TO LEAVE THE RETAINED FOREIGN OBJECT WITHIN THE T12 BODY AS RETRIEVAL WOULD BE MORE DAMAGING, DANGEROUS, AND INVASIVE THAN THE RISKS OF LEAVING THE RETAINED OBJECT WITHIN. A DECISION WAS MADE NOT TO CEMENT THE RIGHT SIDE OF THE BODY AS THERE WAS POTENTIAL FOR LATERAL SIDE WALL FRACTURE DURING BALLOON RUPTURE. ON THE BACK TABLE, BONE CEMENT WAS MIXED AND AFTER WITHDRAWAL OF THE BALLOONS FROM THE VERTEBRAE, THE BONE CEMENT WAS INJECTED UNDER FLUOROSCOPIC GUIDANCE INTO THE T12 VERTEBRAE BILATERALLY WITH EXCELLENT BONE FILL, SHOWING FRACTURE FILL WITH THE CEMENT. AFTER WITHDRAWAL OF THE KYPHOPLASTY CANNULA, AP X-RAYS WERE TAKEN DEMONSTRATING EXCELLENT BONE FILL AT T12. NO PATIENT INJURY.
Patient problems: Foreign Body In Patient
MAUDE report 22521299 ↗
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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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