Delta® 25131-5 (UDI 00643169466425)Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00643169466425), received between Jan 16, 2018 and Feb 10, 2020 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Break” (1 report).

4 other recalls cover devices cleared under the same FDA submission (K042465); 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 10, 2020Break; Break

  ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE GUIDE OF THE SHUNT REFERRED TO THE VENTRICULAR CATHETER. THE PATIENT'S CURRENT STATUS WAS THAT THEY HAD DIED. THERE WERE NO ENVIRONMENTAL/EXTERNAL/PATIENT FACTORS THAT MAY HAVE LED OR CONTRIBUTED TO THE ISSUE.

  Patient problems: Death; No Clinical Signs, Symptoms or Conditions; No Known Impact Or Consequence To Patient

  MAUDE report 9688274 ↗
• MalfunctionOct 16, 2018Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THE DOCTOR WAS IMPLANTING THE VALVE, AND AFTER IMPLANTING THE CATHETERS, THEY DID THE LIQUID DRAINAGE TEST WITH THE VALVE, BUT THEY SAW THAT THE VALVE DID NOT DRAIN THE LIQUID. THE VALVE WAS NEVER IMPLANTED, AND THE DOCTOR DECIDED TO USE A NEW VALVE WHICH DRAINED THE LIQUID. THE NEW VALVE WAS IMPLANTED, AND THE DOCTOR CLOSED THE SKIN. THERE WAS NO INJURY AS A RESULT OF THE EVENT. THE PATIENT'S MEDICAL HISTORY WAS CONGENITAL HYDROCEPHALUS. THEIR STATUS AT THE TIME OF THE REPORT WAS ALIVE-NO INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7971253 ↗
• MalfunctionJan 16, 2018Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THERE WAS NO FLOW THROUGH THE VALVE INTRA-OPERATIVELY. THE PRODUCT WAS NOT USED AND THERE WAS NO INJURY TO THE PATIENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7194263 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K042465. 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-1116-2021 · Jan 11, 2021 · Open, Classified
  Medtronic Cerebro Spinal Fluid Flow Control Valves and Shunts. STRATA II Valves and Shunts for the following CFNs: 27739 - SHUNT 27739 STRATA NSC SNAP SML 120CM, 27740 - SHU
• Z-1121-2017 · Jan 17, 2017 · Terminated
  Medtronic Strata II / Strata NSC Valves (includes Burr Hole and Lumbar Peritoneal. All Catalog Numbers. Strata-type valves are used in the management of hydrocephalus. The Strata
• Z-0399-2014 · Nov 18, 2013 · Terminated
  Medtronic Strata II Shunt Assembly Kit, Small, Catalog No. 27848. Strata II Shunt Assemblies are designed to provide continued cerebrospinal fluid (CSF) flow from the ventricles