OSV II® 909710Recalls & reported problems
Integra LifeSciences Switzerland Sàrl · OSV II® Lumbar Valve System · Class 2 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10381780034018), received between Jan 14, 2022 and Jan 14, 2022 — classified as 1 injury.
The most frequently reported specific device problem is “Fluid/Blood Leak” (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 18, 2026.
Most reported problems
Device problems
- Fluid/Blood Leak1
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.
InjuryJan 14, 2022Fluid/Blood Leak; Fluid/Blood Leak
A FACILITY REPORTED THAT AFTER OSV II LUMBAR VALVE (909710) WAS IMPLANTED IN A PATIENT ON (B)(6) 2021, THE PUMP CHAMBER HAD A LEAKAGE PROBLEM. THE PATIENT HAD A SCHEDULED REVISION AFTER EXTRAPERITONEAL REVISION OF THE DRAIN. THE DRAIN WAS STILL RUNNING, BUT WHEN THE PERITONEAL CATHETER WAS ON HOLD DURING THE PREPARATION OF THE NEW INTRAPERITONEALE ACCESS, LIQUID WAS OBSERVED EVERY 2-3 SECONDS LEAKING OUT OF THE SILICONE SLEEVE OF THE PUMP OF THE OSV II DEVICE. NO OBSERVABLE PATIENT SYMPTOMS WERE REPORTED; HOWEVER, THE FACILITY ADVISED THAT SYMPTOMS WERE LINKED WITH EXTRAPERITONEAL MIGRATION OF THE DISTAL CATHETER. THE PATIENT UNDERWENT REVISION SURGERY ON (B)(6) 2021 WHERE ANOTHER OSV II DEVICE 909710 WAS PLACED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13258001 ↗
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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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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