OSV II® 909712Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10381780034032), received between Nov 19, 2021 and May 1, 2026 — classified as 3 injuries, 1 malfunction.

The most frequently reported specific device problem is “Complete Blockage” (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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 1, 2026Material Too Soft/Flexible; Material Split, Cut or Torn

  A FACILITY REPORTED THAT DURING VENTRICULOPERITONEAL (VP) SHUNT IMPLANTATION FOR HYDROCEPHALUS PROCEDURE, TUNNELING FOR THE PLACEMENT OF THE DISTAL (PERITONEAL) CATHETER WAS PERFORMED WITHOUT COMPLICATIONS. AFTER IMPLANTING THE VENTRICULAR CATHETER INTO THE CEREBRAL VENTRICLE, AT THE TIME OF CONNECTING THE VENTRICULAR CATHETER TO THE VALVE, THE SURGICAL TEAM OBSERVED THAT THE CATHETER PRESENTED A PERFORATION/TEAR AT THE CONNECTION SITE. THE DAMAGED SEGMENT WAS CUT, AND THE CONNECTION ATTEMPT WAS REPEATED; HOWEVER, THE SAME ISSUE OCCURRED THREE CONSECUTIVE TIMES. PROPER COUPLING WAS ONLY ACHIEVED AFTER EXTREMELY DELICATE HANDLING. IN THE NEXT STEP, WHEN POSITIONING THE VALVE IN THE LATERAL POCKET OF THE PATIENT¿S HEAD, THE DEVICE PRESENTED BILATERAL OPENING, WITH THE ONSET OF CEREBROSPINAL FLUID LEAKAGE. ACCORDING TO THE TEAM¿S REPORT, THE MATERIAL APPEARED MORE FRAGILE THAN USUAL, RESEMBLING A DRIED OR BRITTLE CONDITION, BECOMING DAMAGED EVEN UNDER CAREFUL HANDLING AND WITHIN STANDARD TECHNIQUE. THE ISSUE WITH THE PRODUCT DELAYED THE PROCEDURE BY APPROXIMATELY 30 MINUTES; HOWEVER, THERE WAS NO INJURY TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25061728 ↗
• InjuryAug 29, 2024Crack; Fluid/Blood Leak; Crack; Fluid/Blood Leak

  N/A.

  Patient problems: Cerebrospinal Fluid Leakage

  MAUDE report 20103737 ↗
• InjuryJun 13, 2022Complete Blockage; Complete Blockage

  A FACILITY REPORTED THAT THE OSV II VALVE (909712) WAS NOT DRAINING AND THE PATIENT WAS STARTING TO GO BLIND FROM BOTH EYES. FURTHER INFORMATION RECEIVED INDICATES THAT THE VALVE WAS EXPLANTED DUE TO IT BEING BLOCKED, AND THE INCREASED ICP (INTRACRANIAL PRESSURE) LED TO WEAKENED OPTIC NERVES AND IMPACTED VISION. NO ADDITIONAL INFORMATION HAS BEEN MADE AVAILABLE.

  Patient problems: Visual Disturbances

  MAUDE report 14674988 ↗
• InjuryNov 19, 2021Infusion or Flow Problem; Infusion or Flow Problem

  N/A

  Patient problems: Obstruction/Occlusion

  MAUDE report 12845043 ↗