Strata® 42866 (UDI 00613994804648)Recalls & reported problems

Summary

The FDA's MAUDE database contains 75 adverse event reports that list this exact device (DI 00613994804648), received between Dec 6, 2016 and Jun 7, 2024 — classified as 1 death, 29 injuries, 45 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (15 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 75 reports, in the reporter's own words as published by the FDA.

• InjuryJun 7, 2024Break; Fracture; Infusion or Flow Problem; Break; Fracture; Infusion or Flow Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING AN ADJUSTABLE SHUNT. IT WAS REPORTED THAT ON (B)(6), 2017, THE PATIENT WAS ADMITTED TO THE HOSPITAL DUE TO COMA. EXAMINATION REVEALED HYDROCEPHALUS. AFTER FOLLOW-UP, THE PATIENT WAS ADMITTED TO THE HOSPITAL AND UNDERWENT V-P (VENTRICULOPERITONEAL) SHUNT SURGERY. ON (B)(6) 2024, THE PATIENT SUDDENLY HAD CONVULSIONS ON THE LEFT LIMBS, ACCOMPANIED BY HEADACHES, AND WENT TO A LOCAL HOSPITAL FOR TREATMENT. THE DETAILS WERE UNKNOWN. LATER, THE ABOVE SYMPTOMS RECURRED, ACCOMPANIED BY A BRIEF LOSS OF CONSCIOUSNESS. HEAD CT SCAN SHOWED: RIGHT VENTRICLE ENLARGEMENT. HEAD MR SCAN SHOWED: RIGHT LATERAL VENTRICLE EXPANSION AND HYDROPS, RIGHT LATERAL VENTRICLE TOP LOCALIZED PROTRUSION. DIVERTICULUM TO BE EXAMINED. AROUND (B)(6) 2024, THE PATIENT DEVELOPED A SUBCUTANEOUS MASS ON THE RIGHT SIDE OF THE NECK; NO FEVER, HEADACHE, NAUSEA, VOMITING, ETC. FOR FURTHER DIAGNOSIS AND TREATMENT, THE PATIENT CAME TO OUR HOSPITAL FOR A FOLLOW-UP EXAMINATION ON (B)(6) 2024. THE HEAD CT SCAN SHOWED THAT THE RIGHT VENTRICLE OF THE BRAIN HAD CHANGED AFTER DRAINAGE SURGERY, AND COMPARED WITH THE CT SCAN ON (B)(6) 2018, THE CT WAS SIMILAR. THE PATIENT WAS HOSPITALIZED ON (B)

  Patient problems: Cramp(s) /Muscle Spasm(s); Headache; Loss of consciousness

  MAUDE report 19482910 ↗
• MalfunctionJun 24, 2022Fluid/Blood Leak; Fluid/Blood Leak

  MEDTRONIC RECEIVED INFORMATION REGARDING A VALVE USED DURING A HYDROCEPHALUS PROCEDURE. IT WAS REPORTED THAT THE SITE OPENED THE PACKAGE AND FOUND AN AIR LEAKAGE. DELAY INFORMATION WAS NOTED TO BE UNKNOWN. THERE WAS NO REPORTED IMPACT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14801104 ↗
• MalfunctionApr 27, 2022Fluid/Blood Leak; Fluid/Blood Leak

  MEDTRONIC RECEIVED INFORMATION REGARDING A VALVE USED DURING A PROCEDURE. IT WAS REPORTED THAT THE VALVE WAS LEAKING DURING THE FIRST STEP OF IMPLEMENTATION AFTER CONNECTION TO VENTRICULAR DRAIN. NEITHER DELAY NOR PATIENT IMPACT INFORMATION WERE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14219245 ↗
• MalfunctionMar 25, 2022Break; Fracture; Break; Fracture

  MEDTRONIC RECEIVED INFORMATION REGARDING A VALVE USED DURING A PROCEDURE. IT WAS REPORTED THAT THE PRODUCT WAS DAMAGED. IT WAS NOTED THAT THERE WAS A VALVE ASSEMBLY FAILURE. THERE WAS NO REPORTED DELAY TO THE PROCEDURE. THERE WAS NO REPORTED IMPACT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13904523 ↗
• MalfunctionMar 25, 2022Break; Fracture; Break; Fracture

  MEDTRONIC RECEIVED INFORMATION REGARDING A VALVE USED DURING A PROCEDURE. IT WAS REPORTED THAT THE PRODUCT WAS DAMAGED. DELAY AND PA TIENT IMPACT INFORMATION WERE NOT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13904390 ↗
• InjuryJan 10, 2022Infusion or Flow Problem; Infusion or Flow Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A SHUNT BEING USED IN A HYDROCEPHALUS PROCEDURE. IT WAS REPORTED THAT THE PATIENT HAD UNDERGONE A CEREBROSPINAL FLUID SHUNT SURGERY, BUT THE ISSUE COULD NOT BE SOLVED AND THE PATIENT END UP IN A COMA. THE PROCEDURE WAS FOR A NORMAL CEREBROSPINAL FLUID SHUNT. IT WAS DETERMINED THAT THERE WAS A BLOCKAGE IN THE SHUNT PASSAGE. THE WHOLE SET OF SHUNT COULD NOT SOLVE THE PROBLEM OF CEREBROSPINAL FLUID DRAINAGE.

  Patient problems: Hydrocephalus

  MAUDE report 13208629 ↗
• MalfunctionOct 22, 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 12682538 ↗
• MalfunctionJan 21, 2021Fluid/Blood Leak; Fluid/Blood Leak

  ADDITIONAL INFORMATION RECEIVED NOTED THAT THERE WAS NO INJURY TOT HE PATIENT WAS A RESULT OF THE EVENT. THE PATIENT IS CURRENTLY RECOVERING AFTER SURGERY. FURTHER INFORMATION WAS INDICATED TO BE UNKNOWN BY THE PHYSICIAN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11207731 ↗
• MalfunctionOct 28, 2019Mechanics Altered; Mechanics Altered

  ADDITIONAL INFORMATION RECEIVED REPORTED THAT A VALVE ADJUSTMENT WAS MADE TO RESOLVE THE ISSUE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9246013 ↗
• MalfunctionSep 6, 2019Fluid/Blood Leak; Fluid/Blood Leak

  ADDITIONAL INFORMATION RECEIVED REPORTED 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 8971067 ↗
• MalfunctionJul 26, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THE VALVE WAS IMPLANTED ON (B)(6) 2017. ON (B)(6) 2018, DURING A CONTROL VISIT TO ANOTHER HOSPITAL, THE PATIENT WAS SEEN TO BE HAVING SENSORY SYMPTOMS DUE TO SUSPECTED VALVE MALFUNCTION. IT WAS NOTED THAT THE PATIENT HAD NO IMPROVEMENT AFTER THE VALVE WAS IMPLANTED.

  Patient problems: Neurological Deficit/Dysfunction; Therapeutic Effects, Unexpected

  MAUDE report 8830778 ↗
• MalfunctionJul 26, 2019Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT WHEN THE VALVE WAS IMPLANTED, IT WAS SET UP AT 2.5. ON (B)(6) 2017, DURING AN OUTPATIENT VISIT, VENTRICULAR DILATATION WAS LOWERED. ON (B)(6) 2018, THE VALVE WAS SET TO 1.5 DUE TO SUSPECTED MALFUNCTION. THEN ON (B)(6) 2019, DURING AN OUTPATIENT VISIT, THE PATIENT WAS EXPERIENCING PARA-PARESIS AND URINARY INCONTINENCE. A CT SCAN REVEALED VENTRICULAR DILATATION.

  Patient problems: Incontinence; Paresis; Therapeutic Effects, Unexpected

  MAUDE report 8830715 ↗
• MalfunctionJul 26, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT AFTER THE VALVE WAS IMPLANTED, THE VALVE WAS TREATED FROM 2.5 TO 1.5 DUE TO WORSENING OF SENSORY SYMPTOMS. ON (B)(6) 2019, THE PATIENT HAD A WORSENING OF NEUROLOGICAL SYMPTOMS. IT WAS NOTED THAT THERE WERE NO PROBLEMS DURING THE PROCEDURE.

  Patient problems: Neurological Deficit/Dysfunction

  MAUDE report 8830662 ↗
• MalfunctionJul 1, 2019Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT DURING THE VENTRICULOPERITONEAL SURGERY, THE DOCTOR FOUND THAT THE VALVE LEAKED. THE VALVE WAS REPLACED WITH A NEW VALVE OF THE SAME MODEL.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8750604 ↗
• MalfunctionJun 24, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THE PATIENT WAS GETTING WORSE FOR THEIR SHUNT PROCEDURE IN 2017. THEIR SYMPTOMS HAD BEEN: VOMITING, BLURRED VISION, LACK OF ENERGY, PAIN IN AREAS FROM EAR TO THEIR STOMACH, AND THEY HAD BEEN WEARING DIAPERS FROM BLADDER ISSUES. THEIR LAST SHUNT ADJUSTMENT WAS (B)(6) 2019 AFTER AN MRI.

  Patient problems: Blurred Vision; Fatigue; Incontinence; Pain; Vomiting

  MAUDE report 8729110 ↗
• InjuryMay 29, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT AFTER THE VALVE WAS IMPLANTED, THE PATIENT HAD A CLINICAL WORSENING OF THE SENSORIUM. THE PATIENT WAS BEDRIDDEN DESPITE THE CALIBRATION OF THE VALVE. THE VALVE WAS REPLACED WITH ANOTHER DEVICE. THE PATIENT'S STATUS AT THE TIME OF THE REPORT WAS ALIVE-NO INJURY.

  Patient problems: Cognitive Changes

  MAUDE report 8650727 ↗
• InjuryApr 29, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  INFORMATION WAS RECEIVED REGARDING A PATIENT UNDERGOING CEREBRAL PERITONEAL SHUNT SURGERY DUE TO TRAUMATIC BRAIN INJURY. IT WAS REPORTED THAT THE PATIENT HAD A CONTINUOUS FEVER THAT OCCURRED ONE WEEK AFTER SURGERY AND DID NOT IMPROVE. AS THERE WAS A RISK OF INFECTION, THE DEVICE WAS REMOVED. AFTER THE PATIENT RETURNED TO NORMAL ANOTHER SURGERY WAS COMPLETED. THERE WAS NO PRODUCT DAMAGE. THERE WERE NO RELATED PATIENT SYMPTOMS. ADDITIONAL INFORMATION RECEIVED REPORTED THAT NO ADJUSTMENT WAS DONE ANYTIME AFTER IMPLANTATION. NO ACTIVITIES/ANALYSES WERE DONE ON THE VALVE AFTER THE REMOVAL FROM THE PATIENT PRIOR TO SENDING IT TO THE MANUFACTURER. THE VALVE WAS NOT BATHED IN ANY CHEMICALS OR ANTIBIOTICS PRIOR TO IMPLANTATION. NO MRI'S WERE PERFORMED WHILE THE DEVICE WAS IMPLANTED.

  Patient problems: Fever

  MAUDE report 8562406 ↗
• MalfunctionApr 8, 2019Break; Fluid/Blood Leak; Fracture; Break; Fluid/Blood Leak; Fracture

  MEDTRONIC RECEIVED A REPORT THAT, DURING VENTRICULO-PERITONEAL SHUNT SURGERY, A SMALL HOLE WAS FOUND IN THE POSITION OF THE SHUNT VALVE NEAR THE ABDOMINAL END, CAUSING LEAKAGE. THERE WERE NO RELATED PATIENT SYMPTOMS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8491560 ↗
• MalfunctionFeb 15, 2019Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THE DELTA CHAMBER WAS LEAKING DURING THE PROCEDURE. THE VALVE WAS REPLACED AND THERE WAS NO INJURY TO THE PATIENT. (B)(6) 2019.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8346184 ↗
• DeathFeb 1, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  THE ATTORNEY REPORTED THEY WERE PREPARING TO FILE A WRONGFUL DEATH SUIT AFTER THEIR CLIENT DIED FROM A MALFUNCTION OF THE VALVE. NO FURTHER INFORMATION WAS REPORTED.

  Patient problems: Death

  MAUDE report 8298114 ↗
• MalfunctionJan 2, 2019Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THE PATIENT DEVELOPED A SLIT VENTRICLE DUE TO OVERDRAINAGE. THE PATIENT HAD A 3.0 T MRI AND HAD A RETURN OF THEIR HEADACHES, NAUSEA, AND MENTAL CONFUSION. IT WAS STATED THE PATIENT HAS SINCE BEEN DISCHARGED FROM THE HOSPITAL. THE PATIENT WAS REPORTEDLY CONCERNED THE SYMPTOMS WERE RELATED TO A FIELD SAFETY NOTIFICATION FROM JANUARY 2017 WHERE THE ¿SETTING MAY BE REVERSED.¿

  Patient problems: Cognitive Changes; Headache; Nausea; Therapeutic Response, Decreased

  MAUDE report 8208481 ↗
• MalfunctionDec 27, 2018Break; Fluid/Blood Leak; Break; Fluid/Blood Leak

  IT WAS REPORTED THAT DURING THE PROCEDURE, THE VALVE BROKE AND LEAKED. THE VALVE WAS NEVER IMPLANTED AND THERE WAS NO INJURY TO THE PATIENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8200578 ↗
• MalfunctionNov 14, 2018Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT DURING AN EMERGENCY SHUNT IMPLANT PROCEDURE FOR A PATIENT WITH A MEDICAL HISTORY OF BRAIN TUMOR, THE PHYSICIAN FOUND THE VALVE TO BE LEAKING. THE VALVE WAS REPLACED AND THERE WAS NO INJURY TO THE PATIENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8071262 ↗
• InjuryOct 29, 2018Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THE PATIENT HAD CEREBROSPINAL FLUID SHUNT SURGERY ON (B)(6) 2018. WITHIN A HALF A MONTH, IT WAS FOUND THAT THE CEREBROSPINAL FLUID IN THE PATIENT WAS CLOGGED. ON (B)(6) 2018, THE DOCTOR EXPLANTED AND REPLACED THE VALVE IN THE PATIENT'S BODY WITH A NEW VALVE, AND THE POSTOPERATIVE SHUNT WAS NORMAL. 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 8014302 ↗
• InjuryAug 24, 2018Mechanics Altered; Mechanics Altered

  IT WAS REPORTED THE PATIENT WAS IMPLANTED IN (B)(6) 2017 AND HAD DIFFICULT HYDROCEPHALUS. REPORTEDLY ON 3-5 OCCASIONS, THE PATIENT HAD AN MRI AND THE VALVE SETTING WAS CHANGED. FOLLOWING THE MRI, THE VALVE WAS RESET TO 0.5, BUT THE PATIENT DEVELOPED SIGNIFICANT HYDROCEPHALUS SYMPTOMS. IT WAS NOTED THE PATIENT WAS IN THE INTENSIVE CARE UNIT FOR AT LEAST 1 INSTANCE. THE SYMPTOMS WOULD RESOLVE AFTER 2-3 DAYS. IT WAS STATED THE VALVE WAS TAPPED MANY TIMES AND THE SURGEON WAS WONDERING IF THERE WAS ANY DAMAGE TO THE VALVE OR DEBRIS WITHIN THE VALVE THAT COULD HAVE CONTRIBUTED TO THE HYDROCEPHALUS SYMPTOMS. THE VALVE WAS EXPLANTED AND THE PATIENT¿S STATUS WAS NOTED AS ALIVE ¿ NO INJURY.

  Patient problems: Hydrocephalus

  MAUDE report 7812296 ↗

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