Strata™ 92866 (UDI 00763000027322)Recalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 00763000027322), received between Mar 18, 2021 and Nov 14, 2025 — classified as 7 injuries, 7 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (9 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 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 14, 2025Break; Fluid/Blood Leak; Fracture; Break; Fluid/Blood Leak; Fracture

  MEDTRONIC RECEIVED INFORMATION REGARDING AN ADJUSTABLE VALVE. IT WAS REPORTED THAT THE DEVICE WAS LEAKING AND WAS SUSPECTED TO BE BROKEN. THE DEVICE WAS REPLACED WITH A NEW ONE. THE PATIENT'S STATUS AT THE TIME OF THE REPORT WAS ALIVE-NO INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23554439 ↗
• MalfunctionNov 14, 2025Break; Fluid/Blood Leak; Fracture; Break; Fluid/Blood Leak; Fracture

  MEDTRONIC RECEIVED INFORMATION REGARDING AN ADJUSTABLE VALVE. IT WAS REPORTED THAT THE DEVICE WAS LEAKING LIQUID AND WAS SUSPECTED TO BE DAMAGED. THE DEVICE WAS REPLACED WITH A NEW ONE. THE PATIENT'S STATUS AT THE TIME OF THE REPORT WAS ALIVE-NO INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23554301 ↗
• MalfunctionAug 6, 2025Break; Fluid/Blood Leak; Fracture; Break; Fluid/Blood Leak; Fracture

  MEDTRONIC RECEIVED INFORMATION REGARDING AN ADJUSTABLE VALVE. IT WAS REPORTED THAT DURING THE PRE-INFUSION TEST BEFORE IMPLANTATION; IT WAS FOUND THAT THE VALVE WAS DAMAGED AND LEAKING. THE DEVICE WAS REPLACED WITH A NEW ONE. THE PATIENT'S STATUS AT THE TIME OF THE REPORT WAS ALIVE-NO INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22725336 ↗
• InjuryDec 10, 2024Fluid/Blood Leak; Fluid/Blood Leak

  MEDTRONIC RECEIVED INFORMATION REGARDING AN ADJUSTABLE VALVE. IT WAS REPORTED THAT ON (B)(6) 2024, THE CLINICIANS PERFORMED A V ENTRICULOPERITONEAL SHUNT SURGERY. AFTER THE OPERATION WAS COMPLETED NORMALLY, THE PATIENT RETURNED TO THE WARD AND FOUND THAT THE WOUND WAS LEAKING. THE CLINICIANS URGENTLY REMOVED THE LEAKING VALVE AND REPLACED IT WITH A NEW ONE. THE PATIENT'S STATUS AT THE TIME OF THE REPORT WAS ALIVE-NO INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20891783 ↗
• InjuryNov 7, 2024Complete Blockage; Complete Blockage

  MEDTRONIC RECEIVED INFORMATION REGARDING A SHUNT. IT WAS REPORTED THAT AFTER THE SHUNT WAS INSERTED, THE PATIENT EXPERIENCED POOR DRAINAGE, AND THE SYMPTOMS OF HYDROCEPHALUS DID NOT IMPROVE. AFTER INVESTIGATING, IT WAS FOUND THAT THE SHUNT WAS BLOCKED. A SECOND SURGERY WAS PERFORMED TO REPLACE WITH A NEW SHUNT. THE PATIENT'S STATUS AT THE TIME OF THE REPORT WAS ALIVE-NO INJURY.

  Patient problems: Insufficient Information

  MAUDE report 20629841 ↗
• InjuryOct 14, 2024Complete Blockage; Complete Blockage

  MEDTRONIC RECEIVED INFORMATION REGARDING AN ADJUSTABLE SHUNT. IT WAS REPORTED THAT THE PATIENT'S HYDROCEPHALUS DID NOT IMPROVE SIGNIFICANTLY AFTER THE SHUNT SURGERY. IT WAS LATER DISCOVERED THAT THE SHUNT WAS BLOCKED. A SECOND SURGERY WAS PERFORMED TO REPLACE THE SHUNT. THE PATIENT'S STATUS AT THE TIME OF THE REPORT WAS ALIVE-NO INJURY.

  Patient problems: Insufficient Information

  MAUDE report 20438605 ↗
• MalfunctionAug 22, 2024Fluid/Blood Leak; Fluid/Blood Leak

  MEDTRONIC RECEIVED INFORMATION REGARDING AN ADJUSTABLE VALVE. IT WAS REPORTED THAT DURING THE OPERATION, THE BASE OF THE VALVE NEAR THE ABDOMINAL CAVITY WAS LEAKING LIQUID. THE VALVE WAS REPLACED WITH A NEW ONE TO COMPLETE THE OPERATION. THERE WAS A PROCEDURE DELAY OF 10 MINUTES. THE PATIENT'S STATUS AT THE TIME OF THE REPORT WAS ALIVE-NO INJURY. THE PATIENT'S MEDICAL HISTORY WAS HYDROCEPHALUS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20032245 ↗
• InjuryAug 12, 2024Infusion or Flow Problem; Infusion or Flow Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING AN ADJUSTABLE SHUNT. IT WAS REPORTED THAT THE SHUNT WAS IMPLANTED IN 2022, INITIALLY AT 1.5. THERE WAS A CASE OF SHUNT FAILURE DURING THE INITIAL IMPLANTATION, BUT THE CONDITION STABILIZED AFTER REPEATED PRESSURE ADJUSTMENTS. IN (B)(6) 2024 OF THIS YEAR, THE PATIENT CAME TO THE HOSPITAL WITH THE GEAR REDUCED TO 0.5, HOWEVER, THE SHUNT WAS STILL INSUFFICIENT. AFTER REPLACING WITH A NEW SHUNT, THE SYMPTOM OF HYDROCEPHALUS WAS RELIEVED. THE PATIENT'S STATUS AT THE TIME OF REPORT WAS ALIVE-NO INJURY.

  Patient problems: Insufficient Information

  MAUDE report 19959665 ↗
• MalfunctionAug 5, 2024Break; Fracture; Break; Fracture

  MEDTRONIC RECEIVED INFORMATION REGARDING A VALVE/SHUNT. IT WAS REPORTED THAT THE SURGEON FOUND THE VALVE WAS BROKEN WHEN CHECKING THE PATENCY BEFORE IMPLANTATION AND REPORTED A QUALITY PROBLEM. A DIFFERENT PRODUCT WAS USED. THERE WAS NO IMPACT TO PATIENT OUTCOME AS THE DEVICE WAS NEVER IMPLANTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19906355 ↗
• MalfunctionJan 26, 2024Fluid/Blood Leak; Fluid/Blood Leak

  MEDTRONIC RECEIVED INFORMATION REGARDING AN ADJUSTABLE VALVE. IT WAS REPORTED THAT DURING THE OPERATION, VALVE LEAKAGE WAS FOUND WHEN CHECKING THE PATENCY BEFORE THE VALVE WAS IMPLANTED. THE VALVE WAS REPLACED. THERE WAS A PROCEDURE DELAY OF 60 MINUTES. THE PATIENT'S STATUS AT THE TIME OF THE REPORT WAS ALIVE - NO INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18587487 ↗
• InjuryJul 19, 2023Fluid/Blood Leak; Fluid/Blood Leak

  MEDTRONIC RECEIVED INFORMATION REGARDING A SHUNT. IT WAS REPORTED THAT 4 MONTHS AFTER CEREBRAL HEMORRHAGE, THE VP SHUNT OPERATION WAS PERFORMED ON JULY-17, AND LIQUID LEAKAGE OF SHUNT VALVE WAS FOUND DURING THE OPERATION. THE VALVE WAS REPLACED AND RE-IMPLANTED. THERE WAS AN EXTENDED PROCEDURE TIME OF 120 MINUTES. THE PATIENT WAS NOTED TO HAVE INJURY.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 17350292 ↗
• InjurySep 29, 2022Fluid/Blood Leak; Fluid/Blood Leak

  MEDTRONIC RECEIVED INFORMATION REGARDING A SHUNT BEING IMPLANTED DURING A HYDROCEPHALUS CASE. IT WAS REPORTED THE VALVE LEAKED DURING IMPLANTATION. THE DEVICE WAS EXPLANTED AND REPLACED AND THE ISSUE WAS RESOLVED. THERE WAS NO INJURY TO THE PATIENT AND ABOUT A 20 MINUTE DELAY.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 15501716 ↗
• MalfunctionSep 1, 2021Fluid/Blood Leak; Fluid/Blood Leak

  ADDITIONAL INFORMATION RECEIVED REPORTED THAT THERE MAYBE WAS A MORE HARSH MECHANICAL FORCE TO THE VALVE BY THE PHYSICIAN DURING THE VALVE CHECK THAT LEAD TO THE LEAK.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12407992 ↗
• InjuryMar 18, 2021Complete Blockage; Complete Blockage

  ADDITIONAL INFORMATION RECEIVED REPORTED THAT THERE WERE NO ENVIRONMENTAL/EXTERNAL/PATIENT FACTORS THAT MAY HAVE LED OR CONTRIBUTED TO THE ISSUE.

  Patient problems: Insufficient Information

  MAUDE report 11517318 ↗

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