Delta® 25132-5 (UDI 00763000027940)Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00763000027940), received between Mar 20, 2024 and Sep 4, 2025 — classified as 3 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Complete Blockage” (2 reports).

5 other recalls cover devices cleared under the same FDA submission (K902783); they may or may not involve this specific model.

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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• InjurySep 4, 2025Disconnection; Disconnection

  MEDTRONIC RECEIVED INFORMATION REGARDING A SHUNT. IT WAS REPORTED THAT AFTER SURGERY, THE ABDOMINAL END TUBE WAS FOUND TO BE FALLEN OFF. THE TUBE WAS REPLACED WITH A NEW ONE. THERE WAS A PROCEDURE DELAY OF 30 MINUTES. THE PATIENT'S STATUS AT THE TIME OF THE REPORT WAS ALIVE-NO INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22963053 ↗
• InjurySep 3, 2025Complete Blockage; Complete Blockage

  MEDTRONIC RECEIVED INFORMATION REGARDING A VALVE/SHUNT. IT WAS REPORTED THAT DESPITE THE PRESENCE OF PRESSURED CEREBROSPINAL FLUID (CSF), WHEN THE PROXIMAL SIDE OF THE SHUNT WAS IMPLANTED IN THE PATIENT, NO CSF FLOW WAS OBSERVED FROM THE DISTAL END WHEN THE PUMP AND DISTAL END WERE CONNECTED. EVEN WHEN THE TIP WAS LOWERED BELOW THE VENTRICLE LEVEL, NO CSF FLOW WAS OBSERVED DESPITE THE FLOW OF CSF BY PUMPING. THE PATIENT WAS PLACED ON DRAINAGE AND AN ADJUSTABLE SHUNT WAS IMPLANTED. THE PATIENT'S STATUS AT THE TIME OF THE REPORT WAS ALIVE-NO INJURY. ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT DEVELOPED HYDROCEPHALUS BECAUSE THE SHUNT DID NOT FUNCTION AFTER THE PROCEDURE. THE PATIENT EXPERIENCED EPILEPTIC SEIZURES AND SPONTANEOUS RESPIRATORY LOSS AND WERE CONNECTED TO MECHANICAL VENTILATORS, THAT IN PATIENT UNDERGOING REVISION, AN EVD HAD TO BE INSERTED, ON GROUNDS THE SHUNT WAS SEEN TO BE FUNCTIONING BY PUMPING.

  Patient problems: Apnea; Convulsion/Seizure; Hydrocephalus

  MAUDE report 22955589 ↗
• InjuryAug 19, 2025Complete Blockage; Complete Blockage

  ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT DEVELOPED HYDROCEPHALUS BECAUSE THE SHUNT DID NOT FUNCTION AFTER THE PROCEDURE. THE PATIENT EXPERIENCED EPILEPTIC SEIZURES AND SPONTANEOUS RESPIRATORY LOSS AND WERE CONNECTED TO MECHANICAL VENTILATORS, THAT IN PATIENT UNDERGOING REVISION, AN EVD HAD TO BE INSERTED, ON GROUNDS THE SHUNT WAS SEEN TO BE FUNCTIONING BY PUMPING.

  Patient problems: Apnea; Convulsion/Seizure; Hydrocephalus; No Clinical Signs, Symptoms or Conditions

  MAUDE report 22839506 ↗
• MalfunctionJan 21, 2025Break; Fracture; Break; Fracture

  MEDTRONIC RECEIVED INFORMATION REGARDING A VALVE. IT WAS REPORTED THAT THE VALVE PRESENTED FAILURES AS THE RESERVOIR HAD A HOLE. THE PROCEDURE WAS COMPLETED WITH BACK UP PRODUCTS. THE PATIENT'S STATUS AT THE TIME OF THE REPORT WAS ALIVE-NO INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21196507 ↗
• MalfunctionMay 6, 2024Infusion or Flow Problem; Infusion or Flow Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A VALVE. IT WAS REPORTED THAT BEFORE THE PRODUCT WAS IMPLANTED, THE SURGEON CONDUCT A SHUNT PATENCY TEST AND FOUND THAT THE SHUNT COULD NOT FLOW EVEN UNDER A PRESSURE OF 200 MM OF WATER AND COULD ONLY FLOW WHEN THE FLUID RESERVOIR BAG WAS PRESSED. THE SURGEON THOUGHT THE ACTUAL PRESSURE WAS MUCH GREATER THAN THE DESIGN. THE SURGERY WAS SUCCESSFULLY COMPLETED AFTER REPLACING WITH ANOTHER SET OF THE SAME PRODUCT. THERE WAS A 30 MINUTE DELAY IN THE PROCEDURE. THE PATIENT'S STATUS AT THE TIME OF THE REPORT WAS ALIVE-NO INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19247679 ↗
• MalfunctionMar 20, 2024Fluid/Blood Leak; Fluid/Blood Leak

  MEDTRONIC RECEIVED INFORMATION REGARDING A VALVE. IT WAS REPORTED THAT WHEN UNPACKING FOR PRE-PERFUSION, IT WAS FOUND THAT THE SHUNT BODY WAS LEAKING. THE DEVICE WAS REPLACED WITH A BACKUP DEVICE OF THE SAME MODEL. THE PATIENT'S STATUS WAS ALIVE-NO INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18943387 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K902783. One submission often covers many models, so check the product and lot details in each record.

• Z-1115-2021 · Jan 11, 2021 · Open, Classified
  Medtronic Delta CSF (Cerebro Spinal Fluid) -Flow Control Valves for the following CFNs/REF numbers: 24048 - VALVE 24048 DELTA RGL PL 0.5, 24053 - CHAMBER 24053 DELTA, 24147 -
• Z-0871-2021 · Dec 16, 2020 · Open, Classified
  REF 27219-1 X1, Medtronic, Delta Valve, Neonatal, Performance Level 1.0, CE 0344, Sterile EO - Product Usage: Neonatal Delta Snap Shunt Assemblies are components of CSF-Flow Contr
• Z-0872-2021 · Dec 16, 2020 · Open, Classified
  REF 27219-2 X1, Medtronic, Delta Valve, Neonatal, Performance Level 2.0, CE 0344, Sterile EO - Product Usage: Neonatal Delta Snap Shunt Assemblies are components of CSF-Flow Contr
• Z-0873-2021 · Dec 16, 2020 · Open, Classified
  REF 27219-5 X1, Medtronic, Delta Valve, Neonatal, Performance Level 1.5, CE 0344, Sterile EO - Product Usage: Neonatal Delta Snap Shunt Assemblies are components of CSF-Flow Contr
• Z-0398-2014 · Nov 18, 2013 · Terminated
  Medtronic Delta Shunt Assembly Kit with Bioglide Small, Performance Level 1.0, Catalog No. 276201. Delta Shunt Assemblies are designed for use in shunting CSF from the lateral ve