Strata™ 42856Recalls & reported problems

Summary

The FDA's MAUDE database contains 31 adverse event reports that list this exact device (DI 00643169975828), received between Apr 24, 2018 and Mar 31, 2026 — classified as 8 injuries, 23 malfunctions.

The most frequently reported specific device problem is “Break” (6 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 25 most recent of 31 reports, in the reporter's own words as published by the FDA.

• InjuryMar 31, 2026Insufficient Device Problem Information

  ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE VALVE WAS CONDITIONAL AND ALWAYS SCANNED IN NORMAL MODE AND ADJUSTED AFTER MRI.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24742943 ↗
• MalfunctionSep 6, 2024Product Quality Problem; Product Quality Problem

  IT WAS REPORTED THAT UPON X-RAY VERIFICATION, IT WAS DISCOVERED THAT THE RADIOPAQUE MARKERS ARE NOT READILY VISIBLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20157327 ↗
• MalfunctionSep 6, 2024Product Quality Problem; Product Quality Problem

  IT WAS REPORTED THAT UPON X-RAY VERIFICATION, IT WAS DISCOVERED THAT THE RADIOPAQUE MARKERS ARE NOT READILY VISIBLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20157291 ↗
• MalfunctionSep 6, 2024Product Quality Problem; Product Quality Problem

  IT WAS REPORTED THAT UPON X-RAY VERIFICATION, IT WAS DISCOVERED THAT THE RADIOPAQUE MARKERS ARE NOT READILY VISIBLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20157281 ↗
• InjuryAug 9, 2023Mechanics Altered; Mechanics Altered

  MEDTRONIC RECEIVED INFORMATION REGARDING A PATIENT WITH COMPLEX HYDROCEPHALUS. THE PATIENT HAD A SHUNT CONVERTED TO A "VA" IN (B)(6) 2022. THE SHUNT WAS SET TO 1.5, BUT WHEN CHECKED AT THE BEGINNING OF (B)(6) 2023 IT WAS FOUND TO HAVE MOVED TO 1.0. THE SHUNT WAS REPROGRAMMED AT THIS STAGE AND REVIEWED TWO WEEKS LATER, AND THE SHUNT WAS NOT SET AT 2.5. RESET AGAIN TO 1.5. THE PATIENT WAS SEEN AGAIN ON (B)(6) 2023 AND AGAIN READING 1.0. THE DEVICE WAS ALSO CONFIRMED ON X-RAY. THE DOCTOR WAS CONCERNED THAT THE VALVE WAS NOT FUNCTIONING CORRECTLY SO THE DECISION WAS MADE TO REMOVE THE VALVE AND REPLACED. THE PATIENT WAS REPORTED AS ALIVE, AND A PRODUCT HAS BEEN INSERTED. THERE WAS NO REPORTED INFECTIOUS DISEASE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17491172 ↗
• MalfunctionFeb 18, 2022Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION REGARDING A STRATA VALVE. IT WAS REPORTED THAT THE SITE REACHED OUT TO THE MANUFACTURER REPRESENTATIVE TO REQUEST THAT MEDTRONIC INSPECT AN EXPLANTED STRATA VALVE FROM ONE OF THEIR PATIENTS. THEY SUSPECT THAT THE VALVE MAY HAVE BEEN TAMPERED WITH BY A FAMILY MEMBER AND WANTED US TO EVALUATE THE VALVE TO SEE IF MEDTRONIC COULD IDENTIFY THE ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13562424 ↗
• MalfunctionJan 12, 2022Fluid/Blood Leak; Insufficient Device Problem Information; Fluid/Blood Leak; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION REGARDING A VALVE BEING USED IN A PROCEDURE. IT WAS REPORTED THAT WHEN PERFORMING A SHUNT PROCEDURE ON THE PATIENT, THE HEALTH CARE PROFESSIONAL (HCP) OPENED THE SHUNT VALVE AND CHECKED THE PATENCY. IT WAS FOUND THAT THERE WAS FLUID LEAKAGE AT THE EDGE OF THE VALVE. CONSIDERING THE SAFETY OF THE OPERATION AND SUBSEQUENT ADVERSE RISK OF FLUID LEAKAGE, THE HCP REPLACED IT WITH ANOTHER BRAND OF SHUNT TUBE AND PERFORMED THE OPERATION AGAIN. THERE WAS NO REPORTED IMPACT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13237442 ↗
• MalfunctionOct 13, 2021Infusion or Flow Problem; Infusion or Flow Problem

  IT WAS REPORTED THE PHYSICIAN FIRST PUSHED THE VALVE, AND THE CEREBROSPINAL FLUID FLOWED WELL; HOWEVER, THEN THE CEREBROSPINAL FLUID DOES NOT FLOW WHEN IT WAS PRESSED AGAIN. NO FLUID WOULD COME OUT. THE PHYSICIAN WOULD GIVE IT ABOUT 15 MINUTES BEFORE STITCHING AND SEE IF THE CEREBROSPINAL WOULD COME OUT OR NOT, BUT IT TURNED OUT THAT THE FLUID DID NOT COME OUT. WHEN THE VALVE WAS PRESSED AGAIN AFTER THAT, THE CEREBROSPINAL FLUID WOULD NOT FLOW. THE VALVE WAS REPLACED WITH ANOTHER PRODUCT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12625922 ↗
• MalfunctionSep 8, 2021Break; Fluid/Blood Leak; Break; Fluid/Blood Leak

  IT WAS REPORTED THAT WHEN THE DOCTOR PERFORMED THE VENTRICULAR-ABDOMINAL SURGERY AND AFTER IMPLANTING THE END OF THE VENTRICLE, THE DOCTOR IMPLANTED THE ADJUSTABLE PRESSURE VALVE; HOWEVER, WHEN THE DOCTOR SQUEEZED THE VALVE (THE VALVE WAS NOT CHECKED BEFOREHAND), IT WAS FOUND THAT THE CEREBROSPINAL FLUID LEAKED DUE TO THE TOP OF THE VALVE BEING DAMAGED. THE DOCTOR REPLACED THE VALVE WITH ANOTHER ONE OF THE SAME MODEL TO NOT AFFECT THE PATIENT'S SURGERY. THIS RESULTED IN A PROCEDURE DELAY OF 30 MINUTES. THE PATIENT'S STATUS WAS ALIVE-NO INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12441137 ↗
• MalfunctionApr 12, 2021Fluid/Blood Leak; Fluid/Blood Leak

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11653318 ↗
• MalfunctionApr 12, 2021Fluid/Blood Leak; Fluid/Blood Leak

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11652643 ↗
• InjurySep 29, 2020Mechanical Jam; Mechanics Altered; Mechanical Jam; Mechanics Altered

  IT WAS REPORTED THAT 2 YEARS AGO, THE PATIENT WAS IMPLANTED WITH A PRESSURE-ADJUSTABLE SHUNT DUE TO HYDROCEPHALUS. RECENTLY, THE PATIENT DEVELOPED UNCOMFORTABLE SYMPTOMS AND FOUND SUBDURAL EFFUSION DURING A NUCLEAR MAGNETIC RE-EXAMINATION AT THE HOSPITAL. THE PRESSURE OF THE SHUNT CHANGED TO 0.5, AND THE PRESSURE COULD NOT BE ADJUSTED. THE DOCTOR SUSPECTED THAT THE VALVE WAS MALFUNCTIONING, SO THEY SURGICALLY EXPLANTED THE VALVE AND REPLACED IT WAS A NEW ADJUSTABLE PRESSURE VALVE.

  Patient problems: Insufficient Information; Therapeutic Effects, Unexpected

  MAUDE report 10601882 ↗
• MalfunctionJun 19, 2020Infusion or Flow Problem; Infusion or Flow Problem

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

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Known Impact Or Consequence To Patient

  MAUDE report 10175405 ↗
• MalfunctionJun 8, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE DEVICE WAS DEFECTIVE. IT WAS NOTED THAT IT WAS STILL IN THE STERILE PACKAGING AND THE MANUFACTURER REPRESENTATIVE WAS ABLE TO PROGRAM IT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10130767 ↗
• InjuryMay 29, 2020Infusion or Flow Problem; Infusion or Flow Problem

  IT WAS REPORTED THAT AFTER IMPLANTING THE SHUNT WITH THE RIGHT TECHNIQUE, THE DOCTOR CHECKED AND SAW CEREBROSPINAL FLUID FLOW OUT OF THE PERITONEAL CATHETER. AFTER 1 DAY OF IMPLANTATION WITH CLOSE MONITORING, THE PATIENT STARTED TO SHOW SYMPTOMS OF THE SHUNT STUCK. AFTER A FEW DAYS WITH CLINICAL EXAMINATIONS, THE DOCTOR FOUND THAT THE PATIENT'S VENTRICLE WAS ENLARGED. THE DOCTOR DECIDED TO REPLACE THE VALVE WITH ANOTHER VALVE. IT WAS NOTED THAT WHEN THE DOCTOR TOOK THE SHUNT OUT AND CHECKED IT, NO CEREBROSPINAL FLUID FLOWED OUT OF THE VALVE. THE PATIENT'S STATUS AT THE TIME OF THE REPORT WAS ALIVE-WITH INJURY (B)(6) HAD AN ENLARGED VENTRICLE.

  Patient problems: Therapeutic Effects, Unexpected

  MAUDE report 10102116 ↗
• InjuryJan 8, 2020Mechanics Altered; Mechanics Altered

  IT WAS REPORTED THAT THE ISSUE WITH THE VALVE WAS THAT IT WAS AT A DIFFERENT SETTING THAN IT WAS ORIGINALLY SET AT. THE DOCTOR WAS CONCERNED IT WAS CHANGING ON ITS OWN/MALFUNCTIONING. THE VALVE WAS TAKEN OUT AND REPLACED. THEY WERE NOT AWARE OF ANY EXTERNAL FACTORS AFFECTING THE ISSUE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9564552 ↗
• MalfunctionNov 20, 2019Break; Break

  IT WAS REPORTED THAT DURING THE SURGERY, THE DOCTOR FOUND A SMALL HOLE IN THE VALVE. THE VALVE WAS REPLACED WITH ANOTHER ONE OF THE SAME MODEL. IT WAS NOTED THAT THIS RESULTED IN A 60 MINUTE DELAY IN THE PROCEDURE. THE PATIENT'S STATUS AT THE TIME OF THE REPORT WAS ALIVE-NO INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9349024 ↗
• MalfunctionOct 28, 2019Break; Fluid/Blood Leak; Break; Fluid/Blood Leak

  ADDITIONAL INFORMATION RECEIVED CLARIFIED THAT IT SEEMED AS IF THE VALVE WAS POORLY SEALED. IT WAS STATED THERE WERE NO ENVIRONMENTAL/EXTERNAL/PATIENT FACTORS THAT MAY HAVE LED OR CONTRIBUTED TO THE ISSUE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9245174 ↗
• InjurySep 25, 2019Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT THE VALVE HAD POOR DRAINAGE. THE VALVE WAS REPLACED, AND THE NEW VALVE WAS WORKING NORMALLY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9120284 ↗
• MalfunctionJul 29, 2019Break; Break

  IT WAS REPORTED THAT DURING A PROCEDURE, THE VALVE THAT THEY ATTEMPTED TO USE WAS DAMAGED. IT WAS STATED THERE WAS A HOLE IN THE IMPLANT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8837801 ↗
• MalfunctionMar 24, 2019Break; Break

  IT WAS REPORTED THE RESERVOIR ON THE VALVE WAS DAMAGED PRE-OPERATIVELY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8446693 ↗
• MalfunctionJan 10, 2019Break; Break

  IT WAS REPORTED THAT DURING THE PROCEDURE WHILE ATTEMPTING TO CONNECT THE PERITONEAL CATHETER TO THE VALVE, THE END OF THE VALVE SNAPPED. THE BROKEN VALVE WAS REMOVED IN ITS ENTIRETY AND WAS REPLACED. THERE WAS A TWO MINUTE DELAY TO GET A NEW VALVE, BUT THERE WAS NO PATIENT IMPACT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8233035 ↗
• MalfunctionDec 17, 2018Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THE VALVE MALFUNCTIONED DURING THE PROCEDURE. IT WAS STATED THAT VALVE HAD AN ISSUE PRIMING. THE PROCEDURE WAS COMPLETED USING ANOTHER VALVE WHICH WORKED PROPERLY. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8171483 ↗
• MalfunctionDec 11, 2018Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT DURING THE PROCEDURE, THE VALVE WAS PROGRAMMED TO 1.5 AND THEN OPENED ONTO THE SURGICAL FILED. ON THE STERILE FIELD, PRIOR TO IMPLANTATION INTO THE PATIENT, THE VALVE PRESSURE WAS CHECKED MANUALLY WITH A MANOMETER AND FOUND TO BE AT 4 MM H20. IT WAS STATED THAT THIS DOES NOT CORRELATE TO A SETTING OF 1.5 AND WOULD HAVE LED TO SHUNT OVERDRAINAGE (DUE TO TOO LITTLE RESISTANCE). THE VALVE WAS REPLACED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8151597 ↗
• MalfunctionNov 13, 2018Mechanical Jam; Mechanical Jam

  IT WAS REPORTED THE NURSE WAS ATTEMPTING TO ADJUST THE VALVE WITH THE HANDTOOLS PRIOR TO OPENING THE PACKAGE, BUT THE VALVE WOULD NOT ADJUST PAST LEVEL 1.0. MULTIPLE ATTEMPTS WERE MADE TO NO AVAIL. A DIFFERENT VALVE WAS USED ANDWORKED FINE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8066944 ↗

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