Strata® 27888 (UDI 00763000027117)Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00763000027117), received between Mar 21, 2024 and May 28, 2025 — classified as 1 injury, 2 malfunctions.

The most frequently reported specific device problem is “Disconnection” (2 reports).

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.

• InjuryMay 28, 2025Disconnection; Disconnection

  MEDTRONIC RECEIVED INFORMATION REGARDING AN ADJUSTABLE SHUNT. IT WAS REPORTED THAT THE SNAP SHUNT ASSEMBLY WAS COMING UN-SNAPPED AFTER IMPLANTATION. THE PATIENT RETURNED TO SURGERY ON (B)(6) 2025 FOR REMOVAL OF THE SNAP, AND A NEW SHUNT WAS IMPLANTED WITH A NON SNAP.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22100541 ↗
• MalfunctionMay 28, 2025Disconnection; Disconnection

  MEDTRONIC RECEIVED INFORMATION REGARDING AN ADJUSTABLE SHUNT. IT WAS REPORTED THAT THE SNAP SHUNT ASSEMBLY WAS COMING UN-SNAPPED AFTER IMPLANTATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22100445 ↗
• MalfunctionMar 21, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  ADDITIONAL INFORMATION RECEIVED REPORTED THAT THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18954088 ↗

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