Sophysa RE-1021Recalls & reported problems
Sophysa · SIDE INLET CSF RES.FLAT BOTTOM S.M/CATH · Class 2
Data updated Oct 16, 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 03760124130812), received between Aug 6, 2025 and May 13, 2026 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Fluid/Blood Leak” (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 16, 2026.
Reports received per month
Most reported problems
Device problems
- Fluid/Blood Leak2
Patient problems
- No Clinical Signs, Symptoms or Conditions2
- Insufficient Information1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 13, 2026Fluid/Blood Leak
The surgeon reported the LCS leak during the implantation. No consequence has been reported, the device has been replacedduring the surgery.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 25159676 ↗MalfunctionAug 6, 2025Fluid/Blood Leak; Fluid/Blood Leak
THE PHYSICIAN MENTIONS THE LEAKAGE OR RESERVOIR OCCURED ON THE SIDE. ADDITIONAL SURGERY IS REQUIRED TO EXPLANT THE RESERVOIR AND TO REPLACE IT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22725587 ↗
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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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