Codman VersaTru™ 9009050STRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10381780521631), received between Jun 29, 2023 and Jun 29, 2023 — classified as 1 injury.

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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryJun 29, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A FACILITY REPORTED THAT APPROXIMATELY 6 MONTHS AFTER IMPLANTATION, THE OSV II (909700) VALVE APPEARED TO BE MALFUNCTIONING. THE PATIENT BEGAN GETTING HEADACHES, NAUSEA, AND VOMITING, AND THE MRI SHOWED SLIT VENTRICLES. THE VALVE WAS REVISED AND REPLACED WITH HAKIM PROGRAMMABLE VALVE MODEL 82-3162; THE CATHETERS WERE NOT REVISED. THE SURGEON COULD NOT SEE ANYTHING OBVIOUSLY WRONG WITH THE VALVE BUT WAS KEEN TO HAVE IT SENT OFF FOR INVESTIGATION. THE PATIENT HAS BEEN REPORTED AS STABLE. NO SURGICAL DELAY HAS BEEN REPORTED.

  Patient problems: Headache; Nausea; Vomiting

  MAUDE report 17226250 ↗