Delta® 25131-2Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00643169472778), received between Nov 7, 2019 and Nov 7, 2019 — classified as 2 injuries.

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. 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.

• InjuryNov 7, 2019Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT AFTER 2 WEEKS OF SHUNT INSTALLATION, THE VALVE WAS NOT WORKING PROPERLY. IT WAS STATED THAT IT STOPPED WORKING WITH PRESSURE 140-160, BUT ONLY UP TO 170. THE VALVE WAS EXPLANTED AND REPLACED WITH ANOTHER VALVE. THE PATIENT WAS IMPLANTED FOR TRIVENTRICULAR HYDROCEPHALUS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9293247 ↗
• InjuryNov 7, 2019Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT AFTER 2 WEEKS OF SHUNT INSTALLATION, THE VALVE WAS NOT WORKING PROPERLY. IT WAS STATED THAT IT STOPPED WORKING WITH PRESSURE 140-160, BUT ONLY UP TO 170. THE VALVE WAS EXPLANTED AND REPLACED WITH ANOTHER VALVE. THE PATIENT WAS IMPLANTED FOR TRIVENTRICULAR HYDROCEPHALUS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9293236 ↗

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