SOLOPATH SR-1925Recalls & reported problems
Onset Medical Corporation · SOLOPATH Re-collapsible Access System · 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 00852381004340), received between Oct 26, 2018 and Oct 26, 2018 — classified as 1 malfunction.
The most frequently reported specific device problem is “Deflation Problem” (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
- Deflation Problem1
Patient problems
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionOct 26, 2018Deflation Problem; Deflation Problem
THE USER FACILITY REPORTED THAT THE SOLOPATH WAS USED FOR AN ABDOMINAL AORTIC ANEURYSM (AAA) PROCEDURE. THE SOLOPATH WAS PLACED IN THE LEFT GROIN THROUGH A CUT DOWN ACCESS. IT EXPANDED SUCCESSFULLY AND THE APPROPRIATE THERAPEUTIC DEVICES WERE ADVANCED THROUGH THE SHEATH. WHEN IT WAS TIME TO COLLAPSE THE SOLOPATH, THE PHYSICIAN ATTACHED AN INFLATION DEVICE TO THE COLLAPSIBLE PORT AND STARTED TO INFLATE TO 6ATM. THE PHYSICIAN NOTICED IT WAS TAKING SOME TIME TO GET TO 6ATM. THE PHYSICIAN ENDED UP USING FLUOROSCOPY AND NOTICED A POOLING OF CONTRAST. THE PHYSICIAN WAS ABLE TO REMOVE THE SOLOPATH WITHOUT PROBLEM AND BELIEVED THE CAUSE OF THE COLLAPSIBLE BALLOON WAS DUE TO THE PLAQUE/CALCIUM OF THE ARTERY. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THE PATIENT WAS REPORTED TO BE IN STABLE CONDITION.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8009042 ↗
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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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