Delta® 25132-5 (UDI 00613994803672)Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00613994803672), received between Dec 22, 2016 and Mar 1, 2018 — classified as 1 injury, 2 malfunctions.

The most frequently reported specific device problem is “Break” (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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 1, 2018Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT DURING THE PROCEDURE THE VENTRICULAR CATHETER WAS IMPLANTED, AND CEREBROSPINAL FLUID (CSF) FLOW WAS OBSERVED. WHEN CONNECTING THE VALVE AND PALPATING IT, NO CSF FLOW COULD BE OBSERVED. THE CLINICIAN DECIDED THAT THE VALVE WAS NOT WORKING PROPERLY. THE VALVE WAS REPLACED AND NO SYMPTOMS/COMPLICATIONS WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7308768 ↗
• MalfunctionJan 6, 2017Leak/Splash; Leak/Splash

  IT WAS REPORTED TO MEDTRONIC NEUROSURGERY THAT THE PATIENT WAS IMPLANTED DUE TO HYDROCEPHALUS. ACCORDING TO THE REPORT, THE DEVICE WAS LEAKING WHEN BEING CHECKED PRIOR TO SURGERY. REPORTEDLY, THE DOCTOR REPLACED THE DEVICE WITH A NEW DEVICE AND THERE WAS NO IMPACT TO THE PATIENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6229337 ↗
• InjuryDec 22, 2016Break; Inaccurate Flow Rate; Break; Inaccurate Flow Rate

  IT WAS REPORTED TO MEDTRONIC NEUROSURGERY THAT THE DEVICE WAS IMPLANTED IN (B)(6) 2015. ACCORDING TO THE REPORT, IT WAS FOUND THAT THE FLOW THROUGH THE DEVICE WAS POOR AND WHEN CHECKED, IT WAS DETERMINED THE PERITONEAL CATHETER WAS BROKEN. REPORTEDLY, THE SYSTEM WAS REMOVED INCLUDING THE BROKEN PARTS OF THE CATHETER. THE SYSTEM WAS REPLACED AND THE PATIENT WAS WELL.

  Patient problems: Therapeutic Response, Decreased

  MAUDE report 6199679 ↗

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-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-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-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