Delta® 42813 (UDI 00643169466883)Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00643169466883), received between Aug 5, 2018 and Dec 15, 2020 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (1 report).

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.

• MalfunctionDec 15, 2020Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT THE DOCTOR OPENED THE VALVE, AND THEN FILLED THE VALVE WITH FLUID; HOWEVER, THE VALVE LEAKED THROUGH SEVERAL HOLES. THIS RESULTED IN A PROCEDURE DELAY. THE PROCEDURE WAS COMPLETED WITH BACKUP 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 11013464 ↗
• MalfunctionAug 5, 2018Obstruction of Flow; Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT DURING THE PROCEDURE, THE SURGEON COULD NOT GET THE VALVE TO FLOW. AFTER 20 MINUTES, A DIFFERENT VALVE WAS OPENED AND WORKED FINE. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Consequences Or Impact To Patient; No Known Impact Or Consequence To Patient

  MAUDE report 7750330 ↗

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