Strata™ 27819Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00643169975637), received between Feb 12, 2018 and Jul 20, 2023 — classified as 3 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (3 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. 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• InjuryJul 20, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A SHUNT. IT WAS REPORTED THAT 1 YEAR AND 3 MONTHS AFTER THE DEVICE WAS IMPLANTED THE PATIENT WAS INFECTED. THE DEVICE WAS EXPLANTED.

  Patient problems: Unspecified Infection

  MAUDE report 17368316 ↗
• MalfunctionDec 21, 2020Mechanical Jam; Mechanical Jam

  IT WAS REPORTED THAT THE DEVICE WAS PREPARED TO BE SENT TO THE CLINIC FOR USE DURING THE OPERATION, HOWEVER, BEFORE THE OPERATION, THE PRESSURE NEEDED TO BE ADJUSTED TO THE LEVEL OF 1.5 ACCORDING TO THE DOCTOR'S REQUEST, AND THE PRESSURE WAS MEASURED TO THE LEVEL OF 0.5. IT WAS STATED THAT THE MANUAL PRESSURE REGULATOR AND THE ELECTRIC PRESSURE REGULATOR WERE USED BY MULTIPLE PEOPLE WITH MANY ATTEMPTS, BUT THEY FAILED TO ADJUST THE PRESSURE VALUE. IT WAS NOTED THAT HUMAN FACTORS AND PRESSURE REGULATOR FACTORS HAD BEEN ELIMINATED. IT WAS CONSIDERED THAT THE VALVE HAD FAILED, AND A NEW SET HAD BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11046025 ↗
• MalfunctionJul 4, 2020Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT THE SHUNT TUBE WAS PRE-PERFUSED DURING THE SURGERY, DURING WHICH IT WAS FOUND THAT THERE WAS NO WATER AT THE DISTAL SIDE. IT WAS THEN FOUND THAT THE WATER WAS AT THE PROXIMAL SIDE DUE TO A VALVE LEAK. AS A RESULT THE DEVICE WAS REPLACED. THE ISSUE OCCURRED PRIOR TO USE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10230990 ↗
• InjuryMar 30, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE PATIENT WAS IMPLANTED WITH A SHUNT SYSTEM, BUT THE SHUNT EFFECT WAS POOR. IT WAS STATED THAT THE PATIENT'S CEREBROSPINAL FLUID SITUATION DID NOT IMPROVE AFTER THE SHUNT WAS IMPLANTED. THERE WERE NO ENVIRONMENTAL/EXTERNAL/PATIENT FACTORS THAT MAY HAVE LED OR CONTRIBUTED TO THE ISSUE. THE SHUNT SYSTEM WAS REPLACED WITH A NEW ONE. THE PATIENT'S STATUS AT THE TIME OF THE REPORT WAS ALIVE - NO INJURY.

  Patient problems: Therapeutic Effects, Unexpected

  MAUDE report 9898156 ↗
• MalfunctionJan 2, 2019Break; Fluid/Blood Leak; Break; Fluid/Blood Leak

  IT WAS REPORTED THE PATIENT WITH HYDROCEPHALUS DUE TO AN ANEURYSM SURGERY UNDERWENT A SHUNT IMPLANT PROCEDURE. DURING THE OPERATION, THE ¿AIR TIGHTNESS TEST¿ REVEALED THAT THE VALVE WAS DAMAGED AND LEAKED. THE VALVE WAS REPLACED AND THE PATIENT WAS DOING WELL POST-OPERATIVELY. THE PATIENT¿S MEDICAL HISTORY INCLUDED HYPERTENSION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8210287 ↗
• MalfunctionDec 16, 2018Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT DURING THE PATENCY CHECK, THE PHYSICIAN FOUND THAT THE RESERVOIR LEAKED. THE VALVE WAS REPLACED AND THERE WAS NO INJURY TO THE PATIENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8167908 ↗
• InjuryFeb 12, 2018Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THE PATIENT WAS SYMPTOMATIC AND EXPERIENCED NO RELIEF. IT WAS STATED THE VALVE WAS BLOCKED. THE VALVE WAS TO BE REPLACED IN THE FUTURE.

  Patient problems: Therapeutic Response, Decreased

  MAUDE report 7263836 ↗

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