SOLOPATH STFI-1925Recalls & reported problems
Onset Medical Corporation · SOLOPATH Balloon Expandable TransFemoral System · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00852381004265), received between Apr 16, 2019 and Apr 16, 2019 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Detachment of Device or Device Component” (2 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.
Most reported problems
Device problems
- Detachment of Device or Device Component2
Patient problems
- No Patient Involvement2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionApr 16, 2019Detachment of Device or Device Component; Detachment of Device or Device Component
THE USER FACILITY REPORTED THAT THE SOLOPATH DEVICE WAS DAMAGED WHEN THEY TOOK THE SOLOPATH OUT OF THE PACKAGE. THE SILICONE WAS STILL CONNECTED WITH THE SHEATH; HOWEVER, THERE WAS TOO LITTLE SILICONE COVERING THE DISTALLY PART OF THE SHEATH. THERE WERE SOME SHARP EDGES AT THE TRANSITION OF THE SHEATH/TIP. THE DOCTOR TOOK ANOTHER SOLOPATH, WHICH ALSO HAD THE SAME ISSUE. THERE WAS NO PATIENT INVOLVEMENT; THE EVENT OCCURRED BEFORE USE.
Patient problems: No Patient Involvement
MAUDE report 8518339 ↗MalfunctionApr 16, 2019Detachment of Device or Device Component; Detachment of Device or Device Component
THE USER FACILITY REPORTED THAT THE SOLOPATH DEVICE WAS DAMAGED WHEN THEY TOOK THE SOLOPATH OUT OF THE PACKAGE. THE SILICONE WAS STILL CONNECTED WITH THE SHEATH; HOWEVER, THERE WAS TOO LITTLE SILICONE COVERING THE DISTALLY PART OF THE SHEATH. THERE WERE SOME SHARP EDGES AT THE TRANSITION OF THE SHEATH/TIP. THE DOCTOR TOOK ANOTHER SOLOPATH, WHICH ALSO HAD THE SAME ISSUE. THERE WAS NO PATIENT INVOLVEMENT; THE EVENT OCCURRED BEFORE USE.
Patient problems: No Patient Involvement
MAUDE report 8518337 ↗
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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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