OSV II® 909708SRecalls & reported problems
Integra LifeSciences Switzerland Sàrl · OSV II® Valve System · Class 2 · Implant
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10381780035480), received between Jun 28, 2023 and Mar 13, 2024 — classified as 1 injury, 1 malfunction.
The most frequently reported specific device problem is “Material Split, Cut or Torn” (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
- Material Split, Cut or Torn2
- Device Dislodged or Dislocated1
- Fluid/Blood Leak1
Patient problems
- Failure of Implant1
- 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.
MalfunctionMar 13, 2024Fluid/Blood Leak; Material Split, Cut or Torn; Fluid/Blood Leak; Material Split, Cut or Torn
A FACILITY REPORTED THAT DURING IMPLANTATION OF VENTRICULOPERINEAL DIVERSION SYSTEM, THE SURGEON OBSERVED THAT THE OSV II VALVE (909708S) WAS LEAKING WHEN HE WANTED TO FIX THE SYSTEM. A TEAR WAS DISCOVERED ON THE VALVE. THERE WAS INCREASED SURGERY/ANESTHESIA TIME OF 30 MINUTES; HOWEVER, THERE WAS NO CONSEQUENCE FOR THE CHILD PATIENT AS THE DEFECT WAS OBSERVED DURING FIXING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18897081 ↗InjuryJun 28, 2023Device Dislodged or Dislocated; Material Split, Cut or Torn; Device Dislodged or Dislocated; Material Split, Cut or Torn
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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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