Strata® 27888 (UDI 00613994346889)Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00613994346889), received between Dec 6, 2018 and Dec 6, 2018 — classified as 1 injury.

The most frequently reported specific device problem is “Fluid/Blood Leak” (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. 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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryDec 6, 2018Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THE PATIENT WENT TO HAVE A REVISION DUE TO THE PRODUCT ¿NOT WORKING.¿ DURING THE REVISION, THE PHYSICIAN FOUND THAT THE VALVE WAS LEAKING FROM THE DELTA CHAMBER. IT WAS STATED THERE WERE NO EXTERNAL/ENVIRONMENTAL/PATIENT FACTORS IDENTIFIED THAT MAY HAVE LED TO THE ISSUE. THE VALVE WAS REPLACED AND NEW VALVE SEEMED TO BE WORKING FINE.

  Patient problems: Therapeutic Effects, Unexpected

  MAUDE report 8138358 ↗

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-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-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-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