Sophysa SPVA-2010Recalls & reported problems
Sophysa · POLARIS SPVA KIT PREATTACHED/BO19-10 · Class 2 · Implant
- Adverse event reports
- 8
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 03760124131314), received between Sep 15, 2016 and Jul 21, 2026 — classified as 1 injury, 7 malfunctions.
The most frequently reported specific device problem is “Obstruction of Flow” (3 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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Obstruction of Flow3
- Adverse Event Without Identified Device or Use Problem1
- Device Difficult to Program or Calibrate1
- Device Issue1
- Inappropriate or Unexpected Reset1
- Insufficient Device Problem Information1
- Product Quality Problem1
Patient problems
- Hydrocephalus3
- Insufficient Information3
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available1
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 8 most recent of 8 reports, in the reporter's own words as published by the FDA.
MalfunctionJul 21, 2026Obstruction of Flow
The physician implanted the SPVA-2010. In their opinion, the valve was clogged and did not function properly. No testing was performed.
Patient problems: Hydrocephalus
MAUDE report 25886018 ↗InjuryJul 20, 2026Obstruction of Flow
THE PATIENT WAS IMPLANTED WITH A POLARIS VALVE ON (b)(6) 2026. DURING A FOLLOW-UP EXAMINATION CONDUCTED ON (b)(6) 2026, THE PHYSICIAN OBSERVED THAT THE VALVE WAS CLOGGED AND WAS NOT FUNCTIONING PROPERLY. AS A RESULT OF THE DEVICE MALFUNCTION, THE VALVE WAS SURGICALLY EXPLANTED AND REPLACED WITH ANOTHER VALVE.
Patient problems: Hydrocephalus
MAUDE report 25870291 ↗MalfunctionAug 7, 2025Product Quality Problem; Product Quality Problem
THE PHYSICIAN IMPLANTED THE BO19-10 AND HE FOUND THERE WAS NO CSF. HE PULLED OUT THE CATHETER AND FOUND THE MARKING POINT WAS INCORRECT. AFTER CHECKING THE CATHETER, IT WAS FOUND THAT THE MARKING POINTS ON THE CATHETER ARE OPPOSITE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22736559 ↗MalfunctionJun 25, 2025Device Difficult to Program or Calibrate; Device Difficult to Program or Calibrate
A PATIENT WAS IMPLANTED ON TUESDAY, (B)(6) 2025 WITH AN SPVA-2010 VALVE IN VENTRICULO-ATRIAL SHUNT (VAS). THE DOCTOR WAS HAVING DIFFICULTY ADJUSTING THE VALVE TO POSITION 2 (70 MMH2O). THE PATIENT PRESENTED A PICTURE OF HYPERDRAINAGE, AND THE DOCTOR WISHED TO ADJUST THE VALVE TO POSITION 3 OR 4. DESPITE NUMEROUS ATTEMPTS (USE OF A SINGLE MAGNET, DOUBLE MAGNET, WITH OR WITHOUT SELECTOR, REPEATED BACK-AND-FORTH MOVEMENTS, ETC.), IT WAS IMPOSSIBLE TO CHANGE THE VALVE POSITION. AFTER ABOUT AN HOUR OF UNSUCCESSFUL ATTEMPTS, THE DECISION WAS TAKEN TO RE-INTERVENE SURGICALLY AND REPLACE THE VALVE WITH ANOTHER SPVA. THE OPERATION WAS PERFORMED WITHOUT COMPLICATIONS ON SATURDAY, (B)(6) 2025.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 22327022 ↗MalfunctionApr 28, 2025Obstruction of Flow; Obstruction of Flow
MalfunctionFeb 19, 2025Insufficient Device Problem Information; Insufficient Device Problem Information
A MALFUNCTION HAS BEEN OBSERVED ON A SPVA-2010 DEVICE BY THE HOSPITAL PRACTITIONERS. IT CONCERNS A VENTRICULAR SHUNT VALVE, IMPLANTED ON (B)(6) 2021, WHICH PRESENTED NO CONNECTION PROBLEMS AT THE IMPLANTATION TIME, BUT THEN SHOWED TO BE DYSFUNCTIONAL ON USE. THE VALVE HAS BEEN REPLACED.
Patient problems: Insufficient Information
MAUDE report 21408543 ↗MalfunctionJul 22, 2024Inappropriate or Unexpected Reset; Inappropriate or Unexpected Reset
DURING POST-OPERATIVING FOLLOW UP, THE VALVE HAS MALFUNCTIONED.
Patient problems: Insufficient Information
MAUDE report 19791857 ↗MalfunctionSep 15, 2016Device Issue; Adverse Event Without Identified Device or Use Problem; Device Issue
A PATIENT SUFFERED FROM A DILATATION OF THE VENTRICULAR SYSTEM AFTER IMPLANTATION OF THE POLARIS VALVE. NO ALTERATION OF THE DISTAL CATHETER TO THE VALVE SYSTEM AND INTRACRANIAL CATHETER WAS OBSERVED DURING THE SURGICAL ACT, HOWEVER WITHOUT OPERATING THE SYSTEM PRIOR TO THE IMPLANTATION.
Patient problems: Hydrocephalus
MAUDE report 5952057 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.