Delta® 42822Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00643169466869), received between Aug 9, 2017 and Sep 8, 2017 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Occlusion Within Device” (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.

• MalfunctionSep 8, 2017Occlusion Within Device; Device Operates Differently Than Expected; Occlusion Within Device; Device Operates Differently Than Expected

  ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE VALVE WAS NOT DRAINING CEREBROSPINAL FLUID DURING THE PROCEDURE. THE CAUSE OF THE ISSUE WAS NOT DETERMINED. FOLLOWING THE REVISION, THE CONDITION OF THE PATIENT WAS FINE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6852313 ↗
• InjuryAug 9, 2017Occlusion Within Device; Occlusion Within Device

  IT WAS REPORTED TO MEDTRONIC NEUROSURGERY THAT THE DEVICE WAS NOT WORKING PROPERLY. ACCORDING TO THE REPORT, THE PHYSICIAN SAID THERE WAS NO FLOW WHEN THEY DID A FLOW TEST, BUT THERE WAS FLOW WHEN THEY PRESSED ON IT AND NOTICED FLOW ENDOSCOPICALLY. REPORTEDLY, THE DEVICE WAS EXPLANTED.

  Patient problems: Therapeutic Response, Decreased

  MAUDE report 6777699 ↗

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-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-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