Strata® 27816 (UDI 00763000027421)Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00763000027421), received between Mar 6, 2023 and Aug 7, 2024 — classified as 8 malfunctions.

The most frequently reported specific device problem is “Mechanics Altered” (7 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 7, 2024Mechanics Altered; Mechanics Altered

  MEDTRONIC RECEIVED INFORMATION REGARDING AN ADJUSTABLE VALVE. IT WAS REPORTED THAT IN FOLLOW-UP OF PATIENTS WITH IMPLANTED GASTRIC SHUNTS, IT HAD BEEN DISCOVERED THAT THEY HAVE HAD A DIFFERENT ATTITUDE OF RESISTANCE THAN THE ONE PRESCRIBED. IT HAD BEEN DISCOVERED WHEN THE PATIENT NEEDED CARE DUE TO DETERIORATION OF THE CONDITION, IN SOME CASES ACUTELY. UPON DETECTION, THE SETTING HAD BEEN IMMEDIATELY SET BACK TO THE PRESCRIBED STATE. THERE WAS NO DOCUMENTATION SHOWING THAT THE SHUNT WAS DELIBERATELY CHANGED OR THAT THE PATIENT UNDERWENT ANY EXAMINATION OR PROCEDURE THAT COULD AFFECT THE SETTING. THE REACTION COULD NOT BE EXPLAINED BY ANYTHING OTHER THAN SPONTANEOUS CHANGE. THE SHUNT THUS SEEM TO REPOSITION ITSELF, WITH SERIOUS RISKS FOR THE PATIENT AS A CONSEQUENCE.

  Patient problems: Insufficient Information

  MAUDE report 19931440 ↗
• MalfunctionAug 7, 2024Mechanics Altered; Mechanics Altered

  MEDTRONIC RECEIVED INFORMATION REGARDING AN ADJUSTABLE VALVE. IT WAS REPORTED THAT IN FOLLOW-UP OF PATIENTS WITH IMPLANTED GASTRIC SHUNTS, IT HAD BEEN DISCOVERED THAT THEY HAVE HAD A DIFFERENT ATTITUDE OF RESISTANCE THAN THE ONE PRESCRIBED. IT HAD BEEN DISCOVERED WHEN THE PATIENT NEEDED CARE DUE TO DETERIORATION OF THE CONDITION, IN SOME CASES ACUTELY. UPON DETECTION, THE SETTING HAD BEEN IMMEDIATELY SET BACK TO THE PRESCRIBED STATE. THERE WAS NO DOCUMENTATION SHOWING THAT THE SHUNT WAS DELIBERATELY CHANGED OR THAT THE PATIENT UNDERWENT ANY EXAMINATION OR PROCEDURE THAT COULD AFFECT THE SETTING. THE REACTION COULD NOT BE EXPLAINED BY ANYTHING OTHER THAN SPONTANEOUS CHANGE. THE SHUNT THUS SEEM TO REPOSITION ITSELF, WITH SERIOUS RISKS FOR THE PATIENT AS A CONSEQUENCE.

  Patient problems: Insufficient Information

  MAUDE report 19930115 ↗
• MalfunctionAug 7, 2024Mechanics Altered; Mechanics Altered

  MEDTRONIC RECEIVED INFORMATION REGARDING AN ADJUSTABLE VALVE. IT WAS REPORTED THAT IN FOLLOW-UP OF PATIENTS WITH IMPLANTED GASTRIC SHUNTS, IT HAD BEEN DISCOVERED THAT THEY HAVE HAD A DIFFERENT ATTITUDE OF RESISTANCE THAN THE ONE PRESCRIBED. IT HAD BEEN DISCOVERED WHEN THE PATIENT NEEDED CARE DUE TO DETERIORATION OF THE CONDITION, IN SOME CASES ACUTELY. UPON DETECTION, THE SETTING HAD BEEN IMMEDIATELY SET BACK TO THE PRESCRIBED STATE. THERE WAS NO DOCUMENTATION SHOWING THAT THE SHUNT WAS DELIBERATELY CHANGED OR THAT THE PATIENT UNDERWENT ANY EXAMINATION OR PROCEDURE THAT COULD AFFECT THE SETTING. THE REACTION COULD NOT BE EXPLAINED BY ANYTHING OTHER THAN SPONTANEOUS CHANGE. THE SHUNT THUS SEEM TO REPOSITION ITSELF, WITH SERIOUS RISKS FOR THE PATIENT AS A CONSEQUENCE.

  Patient problems: Insufficient Information

  MAUDE report 19929384 ↗
• MalfunctionAug 7, 2024Mechanics Altered; Mechanics Altered

  MEDTRONIC RECEIVED INFORMATION REGARDING AN ADJUSTABLE VALVE. IT WAS REPORTED THAT IN FOLLOW-UP OF PATIENTS WITH IMPLANTED GASTRIC SHUNTS, IT HAD BEEN DISCOVERED THAT THEY HAVE HAD A DIFFERENT ATTITUDE OF RESISTANCE THAN THE ONE PRESCRIBED. IT HAD BEEN DISCOVERED WHEN THE PATIENT NEEDED CARE DUE TO DETERIORATION OF THE CONDITION, IN SOME CASES ACUTELY. UPON DETECTION, THE SETTING HAD BEEN IMMEDIATELY SET BACK TO THE PRESCRIBED STATE. THERE WAS NO DOCUMENTATION SHOWING THAT THE SHUNT WAS DELIBERATELY CHANGED OR THAT THE PATIENT UNDERWENT ANY EXAMINATION OR PROCEDURE THAT COULD AFFECT THE SETTING. THE REACTION COULD NOT BE EXPLAINED BY ANYTHING OTHER THAN SPONTANEOUS CHANGE. THE SHUNT THUS SEEM TO REPOSITION ITSELF, WITH SERIOUS RISKS FOR THE PATIENT AS A CONSEQUENCE.

  Patient problems: Insufficient Information

  MAUDE report 19928818 ↗
• MalfunctionAug 7, 2024Mechanics Altered; Mechanics Altered

  MEDTRONIC RECEIVED INFORMATION REGARDING AN ADJUSTABLE VALVE. IT WAS REPORTED THAT IN FOLLOW-UP OF PATIENTS WITH IMPLANTED GASTRIC SHUNTS, IT HAD BEEN DISCOVERED THAT THEY HAVE HAD A DIFFERENT ATTITUDE OF RESISTANCE THAN THE ONE PRESCRIBED. IT HAD BEEN DISCOVERED WHEN THE PATIENT NEEDED CARE DUE TO DETERIORATION OF THE CONDITION, IN SOME CASES ACUTELY. UPON DETECTION, THE SETTING HAD BEEN IMMEDIATELY SET BACK TO THE PRESCRIBED STATE. THERE WAS NO DOCUMENTATION SHOWING THAT THE SHUNT WAS DELIBERATELY CHANGED OR THAT THE PATIENT UNDERWENT ANY EXAMINATION OR PROCEDURE THAT COULD AFFECT THE SETTING. THE REACTION COULD NOT BE EXPLAINED BY ANYTHING OTHER THAN SPONTANEOUS CHANGE. THE SHUNT THUS SEEM TO REPOSITION ITSELF, WITH SERIOUS RISKS FOR THE PATIENT AS A CONSEQUENCE.

  Patient problems: Insufficient Information

  MAUDE report 19928623 ↗
• MalfunctionAug 7, 2024Mechanics Altered; Mechanics Altered

  MEDTRONIC RECEIVED INFORMATION REGARDING AN ADJUSTABLE VALVE. IT WAS REPORTED THAT IN FOLLOW-UP OF PATIENTS WITH IMPLANTED GASTRIC SHUNTS, IT HAD BEEN DISCOVERED THAT THEY HAVE HAD A DIFFERENT ATTITUDE OF RESISTANCE THAN THE ONE PRESCRIBED. IT HAD BEEN DISCOVERED WHEN THE PATIENT NEEDED CARE DUE TO DETERIORATION OF THE CONDITION, IN SOME CASES ACUTELY. UPON DETECTION, THE SETTING HAD BEEN IMMEDIATELY SET BACK TO THE PRESCRIBED STATE. THERE WAS NO DOCUMENTATION SHOWING THAT THE SHUNT WAS DELIBERATELY CHANGED OR THAT THE PATIENT UNDERWENT ANY EXAMINATION OR PROCEDURE THAT COULD AFFECT THE SETTING. THE REACTION COULD NOT BE EXPLAINED BY ANYTHING OTHER THAN SPONTANEOUS CHANGE. THE SHUNT THUS SEEM TO REPOSITION ITSELF, WITH SERIOUS RISKS FOR THE PATIENT AS A CONSEQUENCE.

  Patient problems: Insufficient Information

  MAUDE report 19928486 ↗
• MalfunctionAug 30, 2023Mechanics Altered; Mechanics Altered

  MEDTRONIC RECEIVED INFORMATION REGARDING A VALVE. IT WAS REPORTED THAT SURGEON TRIED TO CHANGE THE SETTINGS ON THE VALVE AND IT DID NOT WORK AT ALL. NOT TO RAISE AND LOWER BACK THE SETTINGS. THE SURGEON WAS NOT ABLE TO MOVE THE SETTINGS AT ALL WITH THE ADJUSTMENT TOOL. THERE WAS NO PATIENT PRESENT AT THE TIME OF THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17652090 ↗
• MalfunctionMar 6, 2023Mechanical Jam; Mechanical Jam

  MEDTRONIC RECEIVED INFORMATION REGARDING A SHUNT. IT WAS REPORTED THAT BEFORE IMPLANT SURGERY THE DOCTOR WANTED TO ADJUST THE STRATA VALVE TO REQUESTED SETTING FOR THE PATIENT THERAPY. THE SURGEON WAS NOT POSSIBLE TO ADJUST UP AT ANY SETTING AT ALL. THREE ADJUSTMENT TRIALS WERE PERFORMED, WITHOUT ANY POSSIBILITY TO ADJUST THE SETTINGS. THE SHUNT SEEMED TO BE STUCK AND WAS NOT POSSIBLE TO ADJUST. THE PRODUCT WAS REPLACED BY A NEW PRODUCT WHICH WAS SUCCESSFULLY ADJUSTED TO THE REQUESTED SETTING. THERE WAS A DELAY OF 5 MINUTES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16487299 ↗

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