Strata™ 27816Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00643169975606), received between Oct 30, 2018 and Apr 15, 2022 — classified as 1 injury, 3 malfunctions.

The most frequently reported specific device problem is “Break” (1 report).

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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryApr 15, 2022Break; Fracture; Break; Fracture

  MEDTRONIC RECEIVED INFORMATION REGARDING A STRATA DEVICE. IT WAS REPORTED THAT IT WAS BROKEN. ON (B)(6) 2022 THE PATIENT HAD A REVISION SURGERY DUE TO THE SHUNT BEING DAMAGED. THE "SNAP" THAT SHOULD BE ON THE LEFT SIDE OF THE SHUNT WAS ON THE RIGHT. THERE WAS HISTORY OF CLINICAL DETERIORATION FOR SOME MONTHS AND X-RAY PICTURE SHOWS INTERRUPTION AT THE "SNAP" PART. THE REPORTED ISSUE OCCURRED DURING NORMAL USE SINCE THE SHUNT HAD BEEN IN USE SINCE 2018. THERE WAS NO REPORTED IMPACT TO THE PATIENT AFTER THE REVISION SURGERY. THE PATIENT DID RECEIVED ANOTHER MEDTRONIC DEVICE. THE PROCEDURE WAS A SHUNT IMPLANT ON MPH-DIAGNOSIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14117468 ↗
• MalfunctionSep 25, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE SURGEON HAD PROBLEMS WITH THE SNAP VENTRICULAR CATHETER TO ATTACH AND LOCK TOGETHER WITH THE SNAP VALVE CORRECTLY. AFTER TAKING ANOTHER INSTRUMENT AND GOING AROUND THE SNAP MECHANISM ON THE VENTRICULAR CATHETER, THE SURGEON COULD LOCK THE SNAP LOCK TOGETHER WITH THE SNAP VALVE. THE SURGEON DID CHECK EXTRA TIMES (3 TIMES) THAT THE LOCK MECHANISM WORKED CORRECTLY AND WAS CLOSED AND THAT THERE WASN'T ANY CEREBROSPINAL LEAKAGE. NO PROBLEMS OR INFECTIONS WITH THE PATIENT WAS REPORTED AFTER THE PERFORMED SURGERY. THE REPORTED EVENT RESULTED IN A PROCEDURE DELAY OF 15 MINUTES.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10587927 ↗
• MalfunctionOct 17, 2019Mechanical Jam; Mechanical Jam

  IT WAS REPORTED THE VALVE DID NOT CHANGE WHEN USING THE ADJUSTING TOOLS. THE SURGEON HAD ANOTHER ONE ON HAND TO USE FOR THE SURGERY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9202190 ↗
• MalfunctionOct 30, 2018Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT A PATIENT WITH HYDROCEPHALUS WAS TAKEN TO SURGERY FOR INSERTION OF A RIGHT VENTRICULOPERITONEAL SHUNT. THE PREVIOUSLY PLACED EXTERNAL VENTRICULAR DRAIN WAS REMOVED. THE PHYSICIAN USED AN ULTRASOUND TO GUIDE PLACEMENT OF A VENTRICULAR CATHETER. CLEAR FLUID CAM OUT INITIALLY, BUT THE FLOW WAS NOT EXCELLENT. THE CATHETER WAS REVISED, AND ANOTHER TEST WAS DONE OF THE DISTAL RUNOFF. NO RESULTS WITH MULTIPLE PUMPING AND ASPIRATION ATTEMPTS. THE PHYSICIAN INTERROGATED THE PROXIMAL CATHETER WITH A 23 GAUGE BUTTERFLY NEEDLE, AND THERE WAS EXCELLENT FLOW. IT WAS EVIDENT THAT THE VALVE WAS NOT FUNCTIONING PROPERLY. THE PHYSICIAN DISCONNECTED THE SNAP TOP RESERVOIR FROM THE PROXIMAL CATHETER AND REMOVED THE ENTIRE DISTAL SYSTEM INCLUDING THE VALVE AND DISTAL CATHETER AND REPLACED IT WITH A NEW SYSTEM. IMMEDIATELY, CLEAR FLUID WAS VISUALIZED COMING OUT AT THE DISTAL END TUBING.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8019613 ↗

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