Sophysa SPVB-2010Recalls & reported problems
Sophysa · POLARIS SPVB KIT PREATTACHED/BO19-10 · Class 2 · Implant
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 03760124131338), received between Jun 28, 2017 and Jun 12, 2025 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Component Missing” (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.
Reports received per month
Most reported problems
Device problems
- Component Missing1
- Insufficient Device Problem Information1
- Obstruction of Flow1
Patient problems
- Hydrocephalus2
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionJun 12, 2025Obstruction of Flow; Insufficient Device Problem Information; Obstruction of Flow; Insufficient Device Problem Information
THE VALVE WAS REPLACED DURING A SURGERY ON A PATIENT FOR A REASON THAT, APPARENTLY, WAS NOT RELATED TO THE VALVE. ACCORDING TO THE INFORMATION SHARED BY THE PHYSICIAN, THE DOCTOR PREFERS TO REPLACE THE VALVE TO ENSURE THE PATIENT RECEIVES THE BEST VALUE AND CARE. THE DOCTOR ALSO CONFIRMED THAT THE VALVE APPEARED TO BE FUNCTIONING NORMALLY. SINCE WE DO NOT HAVE INFORMATION REGARDING THE REASON FOR THE PROCEDURE, WE HAVE DECIDED TO REPORT THIS CASE.
Patient problems: Hydrocephalus; No Clinical Signs, Symptoms or Conditions
MAUDE report 22194549 ↗MalfunctionJun 28, 2017Component Missing; Component Missing
MISSING COMPONENT: THE VALVE WAS DELIVERED TO (B)(6) WITHOUT THE IFU IN SPANISH, ONLY THE FRENCH/ENGLISH BOOKLET.
Patient problems: Hydrocephalus
MAUDE report 6673169 ↗
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- proSA® FV701TChristoph Miethke GmbH & Co. KG · Shunt, central nervous system and components82 reports
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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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