OSV II® 909711Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10381780034025), received between Dec 6, 2024 and Apr 3, 2026 — classified as 1 injury, 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.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 3, 2026Physical Resistance/Sticking

  A FACILITY REPORTED: "A 29-YEAR-OLD FEMALE PATIENT WAS HOSPITALIZED FOR REMOVAL OF AN INFECTED VENTRICULO-PERITONEAL SHUNT, VENTRICULO-CYSTERNOSTOMY, AND PLACEMENT OF AN EXTERNAL VENTRICULAR SHUNT. DURING INSERTION OF THE INTRA-ABDOMINAL CATHETER WITH AN INTERNAL GUIDEWIRE, THE GUIDEWIRE COULD NOT BE REMOVED. ONCE THE CATHETER WAS INSERTED BEYOND THE NEEDLE, IT BECAME VERY DIFFICULT TO REMOVE THE NEEDLE WITHOUT ALSO REMOVING THE CATHETER. THE CATHETER REMAINED BLOCKED IN THE LUMBAR PUNCTURE NEEDLE, AND THE GUIDEWIRE DAMAGED THE CATHETER." THE EVENT LED TO LESS THAN 30 MINUTES SURGICAL DELAY.

  Patient problems: Insufficient Information

  MAUDE report 24783348 ↗
• InjuryDec 12, 2025Restricted Flow rate; Restricted Flow rate

  A FACILITY REPORTED THAT THE PATIENT WAS EXPERIENCING HEADACHES AND THE SURGEON THOUGHT THAT IT MAY BE DUE TO UNDER DRAINING OF THE OSV II LUMBAR VALVE (909711). THE VALVE WAS REMOVED AND ANOTHER IMPLANTED. THE INITIAL IMPLANTATION DATE HAS NOT BEEN REPORTED, AND IT IS UNKNOWN WHICH VALVE WAS IMPLANTED DURING REVISION SURGERY. PATIENT IS MALE WITH COMPLICATED INPH. ADDITIONAL INFORMATION RECEIVED AS FOLLOWS: "HIS LAST OSV REVISION WAS (B)(6). WELL UNTIL AUGUST. THEN GRADUALLY INCREASING LOW PRESSURE SYMPTOMS, PARTIALLY MANAGED BY GOING UP ON VP SHUNT SETTING & ASD UNTIL REACHING MAX SETTINGS THERE (20MM MAIN VALVE & 40MM ASD). THE PATIENT ALSO HAS A VP SHUNT IN (SO VP AND LP WITH OUR OSV BEING THE LP SHUNT) AND HAS QUITE COMPLEX MANAGEMENT NEEDS."

  Patient problems: Headache

  MAUDE report 23796597 ↗
• MalfunctionDec 6, 2024Component Missing; Component Missing

  A FACILITY REPORTED THAT WHEN THE OSV II LUMBAR KIT (909711) WAS OPENED, IT WAS DISCOVERED THAT THE GUIDEWIRE WAS MISSING FROM THE PACK. THE PRODUCT WAS SPECIFICALLY ORDERED FOR THE PATIENT AND THE FACILITY DID NOT HAVE ANOTHER OSVII KIT AVAILABLE TO USE. THE SURGEON WAS ABLE TO INSERT THE CATHETER OK (RARE OCCURRENCE, USUALLY NEED GUIDEWIRE), AND THE SHUNT WAS IMPLANTED. NO OTHER ISSUES OCCURRED DURING THE CASE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20860859 ↗