Delta® 25131-5 (UDI 00763000027957)Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 00763000027957), received between Jul 11, 2022 and Sep 11, 2026 — classified as 5 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (4 reports).

4 other recalls cover devices cleared under the same FDA submission (K042465); 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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 11, 2026Fluid/Blood Leak

  Medtronic received information regarding a valve. It was reported that the valve was tested before surgery, however, valve leakage occurred. No patient involvement.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50733775 ↗
• MalfunctionDec 22, 2025Complete Blockage; Complete Blockage

  MEDTRONIC RECEIVED INFORMATION REGARDING A VALVE. IT WAS REPORTED THAT THE VALVE WAS OCCLUDED AT THE TIME OF OCCLUSION TESTING. WHEN INJECTING TO CHECK WHETHER THE VALVE SYSTEM WAS PATENT, THE PHYSICIAN FELT SIGNIFICANT RESISTANCE DURING INJECTION. AFTER CONNECTING THE CATHETER, NO FLUID FLOWED DESPITE VERY HIGH PRESSURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23862667 ↗
• MalfunctionOct 17, 2025Fluid/Blood Leak; Fluid/Blood Leak

  MEDTRONIC RECEIVED INFORMATION REGARDING A VALVE. IT WAS REPORTED THAT THERE WAS A LEAK HOLE WHEN TESTING THE VALVE BEFORE THE OPERATION. NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23321743 ↗
• 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 WAS 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 22839498 ↗
• InjuryNov 8, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION REGARDING A VALVE FOR A HYDROCEPHALUS PROCEDURE. IT WAS REPORTED THAT THE PATIENT WAS UNCONSCIOUS AFTER THE DEVICE WAS IMPLANTED. AFTER THAT, THE SURGEON THOUGHT THE SITUATION WAS RELATED TO THE DEVICE AND REMOVED THE DEVICE. THE PROCEDURE WAS COMPLETED WITH BACK UP PRODUCTS. THE PATIENT'S STATUS WAS ALIVE-NO INJURY.

  Patient problems: Loss of consciousness

  MAUDE report 20639676 ↗
• InjuryDec 27, 2022Fluid/Blood Leak; Fluid/Blood Leak

  THERE WAS NO REPORTED IMPACT TO THE PATIENT. THE PATIENT IS ALIVE WITH NO INJURY SINCE THE DOCTOR HAS CHANGED ANOTHER VALVE FOR THE PATIENT RIGHT AFTER ADDRESSING THE ISSUE.

  Patient problems: Cerebrospinal Fluid Leakage

  MAUDE report 16051748 ↗
• MalfunctionDec 14, 2022Break; Fracture; Infusion or Flow Problem; Break; Fracture; Infusion or Flow Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A DELTA VALVE. DURING THE SURGICAL PLACEMENT OF THE DELTA 1.5 SMALL VALVE, THE FOLLOWING WAS DETECTED; AN UNUSUAL HOLE IN THE SILASTIC OF THE VALVE BODY, AND NON-FUNCTIONING OF THE VALVE SYSTEM ONCE THE BLOCKAGE WAS PLACED. THIS OCCURRED IN THE MIDDLE OF SURGERY AND THE FAILURE WAS CONFIRMED ONCE IT WAS PLACED AND ASSEMBLED, WITHOUT BEING ABLE TO WEIGH THE LIQUID THROUGH THE DISTAL CATHETER, NOR WITH REPEATED PUMPING OF THE PUSH BUTTON. IT WAS REPLACED IMMEDIATELY BY ANOTHER SYSTEM AND THE ISSUE WAS RESOLVED. THE VALVE WAS PLACED AND ASSEMBLED AND THEN THE HOLE WAS FOUND IN THE PRODUCT. THEREFORE, IT WAS EXPLANTED AND REPLACED WITH A VALVE EQUAL TO THE FIRST ONE BUT WITHOUT DAMAGE.

  Patient problems: No Clinical Signs, Symptoms or Conditions; Unspecified Tissue Injury

  MAUDE report 15977928 ↗
• InjuryJul 25, 2022Infusion or Flow Problem; Infusion or Flow Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A VALVE SYSTEM BEING USED FOR A PROCEDURE. IT WAS REPORTED THAT THE DEVICE FAILED. WHEN THE SHUNT WAS ALLOCATED AND CONNECTED TO THE CATHETER IT DID NOT DRAIN AS IT WAS SUPPOSED TO. THE HEALTH CARE PROFESSIONAL TRIED TO MAKE SOME PRESSURE INTO THE SHUNT TO MAKE IT DRAIN AND IT DID, BUT WHEN THE PRESSURE WAS NOT MADE IT DIDNOT DRAIN. THE EVENT WAS RESOLVED BY USING A DIFFERENT PRODUCT. THERE WAS A 30 MINUTE DELAY AND NO REPORTED IMPACT TO PATIENT OUTCOME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15093583 ↗
• InjuryJul 11, 2022Break; Fluid/Blood Leak; Fracture; Break; Fluid/Blood Leak; Fracture

  MEDTRONIC RECEIVED INFORMATION REGARDING A SHUNT BEING USED IN A PROCEDURE. IT WAS REPORTED THAT AFTER THE PUNCTURE WAS SUCCESSFUL, IT WAS FOUND THAT THE VALVE HAD A CRACK AND LEAKED FLUID. THE HEALTH CARE PROFESSIONAL STATED THAT AFTER A SUCCESSFUL PUNCTURE, DURING THE PROCESS OF FIXING THE BUTTERFLY BUCKLE OF THE DRAINAGE TUBE, IT WAS FOUND THAT THERE WAS A CRACK IN THE SHUNT, AND CEREBROSPINAL FLUID LEAKED FROM THE CRACK. THE SITE REPLACED WITH THE SHUNT WITH ANOTHER PRODUCT AT THE SITE. THERE WAS NO REPORTED IMPACT TO THE PATIENT. THE PROCEDURE BEING PERFORMED WAS A CEREBROSPINAL FLUID SHUNT SURGERY. THE PATIENT WAS IN GOOD CONDITION AFTER THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14978571 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K042465. 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-1116-2021 · Jan 11, 2021 · Open, Classified
  Medtronic Cerebro Spinal Fluid Flow Control Valves and Shunts. STRATA II Valves and Shunts for the following CFNs: 27739 - SHUNT 27739 STRATA NSC SNAP SML 120CM, 27740 - SHU
• Z-1121-2017 · Jan 17, 2017 · Terminated
  Medtronic Strata II / Strata NSC Valves (includes Burr Hole and Lumbar Peritoneal. All Catalog Numbers. Strata-type valves are used in the management of hydrocephalus. The Strata
• Z-0399-2014 · Nov 18, 2013 · Terminated
  Medtronic Strata II Shunt Assembly Kit, Small, Catalog No. 27848. Strata II Shunt Assemblies are designed to provide continued cerebrospinal fluid (CSF) flow from the ventricles