Solus G25674Recalls & reported problems
Cook Ireland Ltd · Solus, Double Pigtail Stent with Introducer · Class 2 · Implant
All models of Solus (7)
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 10827002256740), received between Jan 5, 2023 and Jan 5, 2023 — classified as 1 malfunction.
The most frequently reported specific device problem is “Difficult to Advance” (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
- Difficult to Advance1
- Physical Resistance/Sticking1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionJan 5, 2023Difficult to Advance; Physical Resistance/Sticking; Difficult to Advance; Physical Resistance/Sticking
THE STENT VERY DIFFICULT TO LOAD INTO THE GUIDING CATHETER, AND DIFFICULT TO DEPLOY, THE GUIDING CATHETER HAS BEEN BROKEN BECAUSE FORCE TO DEPLOY. THE WHOLE SYSTEM HAS BEEN TAKEN OUT FROM PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16102040 ↗
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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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