Delta® 42813 (UDI 00763000028367)Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00763000028367), received between Jan 28, 2025 and May 15, 2026 — classified as 1 injury, 4 malfunctions.

The most frequently reported specific device problem is “Complete Blockage” (3 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 15, 2026Complete Blockage

  ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE DOCTOR WAS CONFUSED, AND THE FAULTY PRODUCT WAS NOT A MEDTRONIC PRODUCT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25182622 ↗
• MalfunctionJan 22, 2026Complete Blockage

  MEDTRONIC RECEIVED INFORMATION REGARDING A VALVE. IT WAS REPORTED THAT THE VALVE WAS OCCLUDED AT THE TIME OF VALVE OCCLUSION TESTING. WHEN INJECTING TO CHECK WHETHER THE VALVE SYSTEM WAS PATENT, THE PHYSICIAN FOUND THAT INJECTION WAS VERY DIFFICULT. WHEN THE CATHETER WAS CONNECTED, NO FLUID FLOWED DESPITE VERY HIGH PRESSURE. NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24147974 ↗
• MalfunctionJan 16, 2026Complete Blockage

  MEDTRONIC RECEIVED INFORMATION REGARDING A VALVE. IT WAS REPORTED THE VALVE WAS OBSTRUCTED AT THE TIME OF THE PATENCY TEST. WHEN INJECTING TO CHECK WHETHER THE VALVE SYSTEM WAS PATENT, THE PHYSICIAN NOTED VERY HIGH RESISTANCE. WHEN CONNECTED TO THE CATHETER, NO FLUID FLOWED DESPITE VERY HIGH PRESSURE. NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24092493 ↗
• InjuryAug 22, 2025Infusion or Flow Problem; Insufficient Device Problem Information; Infusion or Flow Problem; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION REGARDING A VALVE. IT WAS REPORTED THAT AFTER THE VALVE IMPLANTATION IN (B)(6), THE PATIENT DID NOT IMPROVE AS THE VALVE WAS NOT FUNCTIONAL. ANOTHER EMERGENCY PROCEDURE WAS PERFORMED TO REPLACE THE VALVE WITH AN ADJUSTABLE VALVE.

  Patient problems: Dizziness; Headache; Insufficient Information; Intracranial Hemorrhage

  MAUDE report 22878082 ↗
• MalfunctionJan 28, 2025Break; Fracture; Break; Fracture

  MEDTRONIC RECEIVED INFORMATION REGARDING A VALVE. IT WAS REPORTED DURING THE SHUNT PLACEMENT OPERATION, A HOLE WAS DETECTED IN THE PRODUCT. THE PROCEDURE WAS COMPLETED WITH BACK UP PRODUCTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21252026 ↗

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-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-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-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