Strata® 27818Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00763000027407), received between May 21, 2021 and Jan 16, 2026 — classified as 3 malfunctions.

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

2 other recalls cover devices cleared under the same FDA submission (K060681); 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.

• MalfunctionJan 16, 2026Fluid/Blood Leak

  MEDTRONIC RECEIVED INFORMATION REGARDING AN ADJUSTABLE SHUNT. IT WAS REPORTED THAT DURING THE PRODUCT IMPLANTATION PROCESS, LIQUID LEAKAGE WAS DETECTED DURING THE PATENCY TEST. NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24092571 ↗
• MalfunctionOct 24, 2023Break; Fracture; Break; Fracture

  MEDTRONIC RECEIVED INFORMATION REGARDING A SHUNT USED DURING A PROCEDURE. IT WAS REPORTED THAT DURING THE PATIENT'S SHUNT SURGERY, IT WAS DISCOVERED THAT THE TUBE WAS BROKEN DURING THE IMPLANTATION OF THE ABDOMINAL CATHETER. THE PROCEDURE WAS COMPLETED WITH BACKUP PRODUCTS. THERE WAS A REPORTED DELAY TO THE PROCEDURE OF 20 MINUTES. THERE WAS NO REPORTED IMPACT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17996122 ↗
• MalfunctionMay 21, 2021Break; Fluid/Blood Leak; Break; Fluid/Blood Leak

  IT WAS REPORTED THAT WHEN THE DOCTOR IMPLANTED THE ADJUSTABLE PRESSURE VALVE AND THE END OF THE ABDOMINAL CAVITY, THE VALVE WAS SQUEEZED, AND IT WAS FOUND THAT THE CEREBROSPINAL LEAKED BECAUSE OF A HOLE IN THE MIDDLE OF THE VALVE. IT WAS NOTED THAT THE VALVE WAS NOT CHECKED BEFOREHAND. THE PRODUCT WAS REPLACED WITH ANOTHER ONE TO NOT AFFECT THE OPERATION. THIS REPORTED EVENT RESULTED IN A 30 MINUTE PROCEDURE DELAY. THE PATIENT'S STATUS WAS ALIVE - NO INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11863893 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K060681. 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-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