H-V Lumbar Valve System 903345ARecalls & reported problems
Integra Neurosciences Implant (France) · The Horizontal-Vertical Lumbar Valve System is an implantable device that provides controlled intraventricular pressure and cerebrospinal fluid (CSF) drainage from the lumbar subarachnoid region to the peritoneal cavity. The system minimizes overdrainage by automatically compensating for changes in CSF hydrostatic pressure when the patient changes from a recumbent to an upright position. Available in different closing pressure ranges (according horizontal and vertical orientations). · Class 2 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10381780035404), received between Jun 1, 2018 and Jun 1, 2018 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Device Issue” (3 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 18, 2026.
Most reported problems
Device problems
- Device Issue3
- Material Fragmentation3
Patient problems
- No Known Impact Or Consequence To Patient3
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionJun 1, 2018Material Fragmentation; Device Issue; Material Fragmentation; Device Issue
THREE SEPARATE LUMBOPERITONEAL SHUNT SYSTEM WERE OPENED DUE TO DEFECTIVE IMPLANTS. CATHETER WAS TEARING EASILY WHILE DR (B)(6) WAS ATTEMPTING TO PLACE THE SHUNT. NONE OF THE IMPLANTS WERE EXPIRED. MD REQUESTS THAT IMPLANTS BE FURTHER INVESTIGATED . TWO SYSTEMS NOTED ABOVE WERE WASTED. PATIENT CAME BACK AT A LATER DATE AND HAD REMOVAL OF VENTRICULO PERITONEAL SHUNT AND LP SHUNT, DR (B)(6) LAPAROSCOPIC ASSISTED LUMBOPERITONEAL SHUNT PLACEMENT. PATIENT CAME BACK AT A LATER DATE AND HAD REMOVAL OF VENTRICULO PERITONEAL SHUNT AND LP SHUNT, DR (B)(6) LAPAROSCOPIC ASSISTED LUMBOPERITONEAL SHUNT PLACEMENT . CROSS REFERENCE MEDWATCH REPORT NUMBERS 2023988-2018-00026 AND 2023988-2018-00027. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7561554 ↗MalfunctionJun 1, 2018Material Fragmentation; Device Issue; Material Fragmentation; Device Issue
THREE SEPARATE LUMBOPERITONEAL SHUNT SYSTEM WERE OPENED DUE TO DEFECTIVE IMPLANTS. CATHETER WAS TEARING EASILY WHILE (B)(6) WAS ATTEMPTING TO PLACE THE SHUNT. NONE OF THE IMPLANTS WERE EXPIRED. MD REQUESTS THAT IMPLANTS BE FURTHER INVESTIGATED . TWO SYSTEMS NOTED ABOVE WERE WASTED. PATIENT CAME BACK AT A LATER DATE AND HAD REMOVAL OF VENTRICULO PERITONEAL SHUNT AND LP SHUNT, (B)(6) LAPAROSCOPIC ASSISTED LUMBOPERITONEAL SHUNT PLACEMENT. PATIENT CAME BACK AT A LATER DATE AND HAD REMOVAL OF VENTRICULO PERITONEAL SHUNT AND LP SHUNT, (B)(6) LAPAROSCOPIC ASSISTED LUMBOPERITONEAL SHUNT PLACEMENT. CROSS REFERENCE MEDWATCH REPORT NUMBERS 2023988-2018-00027 AND 2023988-2018-00028. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7561523 ↗MalfunctionJun 1, 2018Material Fragmentation; Device Issue; Material Fragmentation; Device Issue
THREE SEPARATE LUMBOPERITONEAL SHUNT SYSTEM WERE OPENED DUE TO DEFECTIVE IMPLANTS. CATHETER WAS TEARING EASILY WHILE DR BARI WAS ATTEMPTING TO PLACE THE SHUNT. NONE OF THE IMPLANTS WERE EXPIRED. MD REQUESTS THAT IMPLANTS BE FURTHER INVESTIGATED . TWO SYSTEMS NOTED ABOVE WERE WASTED. PATIENT CAME BACK AT A LATER DATE AND HAD REMOVAL OF VENTRICULO PERITONEAL SHUNT AND LP SHUNT, DR BARI LAPAROSCOPIC ASSISTED LUMBOPERITONEAL SHUNT PLACEMENT. PATIENT CAME BACK AT A LATER DATE AND HAD REMOVAL OF VENTRICULO PERITONEAL SHUNT AND LP SHUNT, (B)(6) LAPAROSCOPIC ASSISTED LUMBOPERITONEAL SHUNT PLACEMENT . CROSS REFERENCE MEDWATCH REPORT NUMBERS 2023988-2018-00026 AND 2023988-2018-00028. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7561516 ↗
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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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