Delta® 42812 (UDI 00763000028374)Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00763000028374), received between Jan 10, 2024 and Jan 10, 2024 — classified as 2 injuries.

The most frequently reported specific device problem is “Infusion or Flow Problem” (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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryJan 10, 2024Infusion or Flow Problem; Insufficient Device Problem Information; Infusion or Flow Problem; Insufficient Device Problem Information

  ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT UNDERWENT SHUNT PLACEMENT BACK IN (B)(6) 2023 AND DID VERY WELL FOR ABOUT 2 MONTH BUT THEN SUBSEQUENTLY HAD A VALVE MALFUNCTION FOR WHICH THEY UNDERWENT VALVE REPLACEMENT AND THEN DEVELOPED WHAT THE DOCTOR FIGURED WERE LOW-PRESSURE HEADACHES. THE PATIENT CAME IN FOR DIAGNOSTIC TESTING IN THE FALL AND EARLY WINTER OF 2023 WITH A WORKING SHUNT. HOWEVER, THEY HAD SEVERE HEADACHES AND UNDERWENT PLACEMENT OF A RIGHT EXTERNAL VENTRICULAR DRAIN AT THAT TIME. DESPITE THEIR VENTRICLES BEING ON THE PLUMPER SIDE, THEIR INTRACRANIAL PRESSURES AT THAT TIME WERE LOW, AND THEY DID BETTER WITH THE EXTERNAL VENTRICULAR DRAIN SET AT A HIGHER SETTING AND AN ABDOMINAL BINDER. THUS, THE PATIENT WAS TAKEN IN THE WINTER FOR A VALVE REPLACEMENT IN WHICH THEIR VALVE WITH PRESSURE LEVEL 1.0 WAS CHANGED OUT TO A VALVE WITH A PRESSURE LEVEL 1.5.

  Patient problems: Headache; Insufficient Information

  MAUDE report 18485915 ↗
• InjuryJan 10, 2024Infusion or Flow Problem; Insufficient Device Problem Information; Infusion or Flow Problem; Insufficient Device Problem Information

  ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT UNDERWENT SHUNT PLACEMENT BACK IN (B)(6) 2023 AND DID VERY WELL FOR ABOUT 2 MONTH BUT THEN SUBSEQUENTLY HAD A VALVE MALFUNCTION FOR WHICH THEY UNDERWENT VALVE REPLACEMENT AND THEN DEVELOPED WHAT THE DOCTOR FIGURED WERE LOW-PRESSURE HEADACHES. THE PATIENT CAME IN FOR DIAGNOSTIC TESTING IN THE FALL AND EARLY WINTER OF 2023 WITH A WORKING SHUNT. HOWEVER, THEY HAD SEVERE HEADACHES AND UNDERWENT PLACEMENT OF A RIGHT EXTERNAL VENTRICULAR DRAIN AT THAT TIME. DESPITE THEIR VENTRICLES BEING ON THE PLUMPER SIDE, THEIR INTRACRANIAL PRESSURES AT THAT TIME WERE LOW, AND THEY DID BETTER WITH THE EXTERNAL VENTRICULAR DRAIN SET AT A HIGHER SETTING AND AN ABDOMINAL BINDER. THUS, THE PATIENT WAS TAKEN IN THE WINTER FOR A VALVE REPLACEMENT IN WHICH THEIR VALVE WITH PRESSURE LEVEL 1.0 WAS CHANGED OUT TO A VALVE WITH A PRESSURE LEVEL 1.5.

  Patient problems: Headache; Insufficient Information

  MAUDE report 18485908 ↗

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