SoloPace Fusion Sterile Pack K12-12621Recalls & reported problems
Solo Pace Inc. · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 4
- Deaths reported
- 0
- Injuries reported
- 4
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00850056280044), received between Sep 9, 2026 and Sep 30, 2026 — classified as 4 injuries.
The most frequently reported specific device problem is “Intermittent Capture” (4 reports).
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 18, 2026.
Reports received per month
Most reported problems
Device problems
- Intermittent Capture4
Patient problems
- Insufficient Information3
- Aortic dissection1
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
InjurySep 30, 2026Intermittent Capture
Patient problems: Insufficient Information
MAUDE report 50951238 ↗InjurySep 30, 2026Intermittent Capture
Customer reports that the valve embolized while using SoloPace Fusion. Valve that embolized required a stent to secure. Patient outcome was good.
Patient problems: Insufficient Information
MAUDE report 50951237 ↗InjurySep 9, 2026Intermittent Capture
Patient problems: Insufficient Information
MAUDE report 50698377 ↗InjurySep 9, 2026Intermittent Capture
The following was reported: "Customer reports they were completing a TAVR with Medtronic Evolut valve. Shallow core valve and embolized on post dil. Patient did not need open surgery, they left the valve in place and placed a new Evolut Medtronic valve."The valve embolization resulted in a vessel dissection that was addressed through vascular surgical intervention. The patient did not require any additional treatment following the intervention, and the patient outcome was reported as good.
Patient problems: Aortic dissection
MAUDE report 50698376 ↗
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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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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