Strata™ 42866Recalls & reported problems

Summary

The FDA's MAUDE database contains 56 adverse event reports that list this exact device (DI 00643169975835), received between May 2, 2018 and Nov 8, 2024 — classified as 20 injuries, 36 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (25 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 56 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 8, 2024Mechanics Altered; Mechanics Altered

  MEDTRONIC RECEIVED INFORMATION REGARDING AN ADJUSTABLE VALVE. IT WAS REPORTED THAT THE SHUNT SETTING CHANGED, BUT THE PATIENT HAD NOT HAD A RECENT MAGNETIC RESONANCE IMAGING (MRI). THE VALVE WAS REPROGRAMMED. THE PATIENT'S STATUS AT THE TIME OF THE REPORT WAS ALIVE-NO INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20640382 ↗
• MalfunctionOct 30, 2024Mechanics Altered; Mechanics Altered

  MEDTRONIC RECEIVED INFORMATION REGARDING AN ADJUSTABLE VALVE. IT WAS REPORTED THAT THE PATIENT'S SHUNT HAD ALLEGEDLY CHANGED PROGRAMMING ON ITS OWN. IT WOULD BE SET AT 1.0, AND THE NEXT TIME IT WAS CHECKED, IT WOULD BE AT 2.0. THE PATIENT HAD BEEN IN A NURSING HOME SINCE (B)(6) 2022 AND NOT ANYWHERE NEAR A MAGNET. THE PATIENT'S MEDICAL RECORDS DOCUMENTED NUMEROUS TIMES (GOING BACK TO 2021 TO (B)(6) 2024) OF THE SHUNT CHANGING ITS SETTING ON ITS OWN. THE FAMILY THOUGHT IF IT WAS NOT STAYING ON THE SETTING IT WAS SET VIA A MAGNET, THEN IT WAS DEFECTIVE. IT WAS NOTED THE PATIENT WAS BASICALLY NON-AMBULATORY AND NON-VERBAL BECAUSE THE FAMILY BELIEVED THE SHUNT WAS NOT WORKING CORRECTLY. THE PATIENT INITIALLY WAS SET TO 1.0 AFTER IMPLANT, AND AFTER 6 WEEKS, THE PATIENT WAS INTERESTED TO SEE IF INCREASED CEREBROSPINAL FLUID (CSF) DRAINAGE WOULD IMPROVE THEIR SYMPTOMS FURTHER. THE PATIENT'S VALVE WAS THEN SET TO 0.5. AFTER 2 WEEKS, THE PATIENT WAS SEEN IN THE CLINIC WHERE THEY HAD SIGNIFICANT CLINICAL IMPROVEMENT AT THE VALVE SETTING OF 0.5, H HOWEVER, THEY HAD DEVELOPED BILATERAL SMALL HYGROMAS. SINCE THE PATIENT WAS DOING WELL WITH NO HEADACHES, THE PATIENT WAS GOING TO BE CLOSELY FOLLO

  Patient problems: Ambulation or Postural Difficulties; Dysphasia; Seroma

  MAUDE report 20570948 ↗
• InjuryJan 29, 2021Complete Blockage; Complete Blockage

  IT WAS REPORTED THAT THE PATIENT WAS ADMITTED TO THE HOSPITAL DUE TO NORMAL PRESSURE HYDROCEPHALUS. ON (B)(6) 2020, THEY UNDERWENT VENTRICULAR-ABDOMINAL SHUNT SURGERY UNDER GENERAL ANESTHESIA. DURING THE OPERATION, THE VENTRICULAR-ABDOMINAL SHUNT WAS USED FOR DRAINAGE, AND THE PATIENT'S CONSCIOUSNESS IMPROVED AFTER THE OPERATION. ON (B)(6) 2021, IT WAS DISCOVERED THAT THE PATIENT'S CONSCIOUSNESS DISORDER WAS DEEPER THAN BEFORE. ON (B)(6) 2021, THE VENTRICULAR-ABDOMINAL SHUNT WAS REPLACED UNDER GENERAL ANESTHESIA. DURING THE OPERATION, THE VALVE WAS FOUND TO BE YELLOW AND BLOCKED. IT WAS NOTED THAT IT WAS CONSIDERED THE INCREASE IN CEREBROSPINAL FLUID PROTEIN OR THE PRESENCE OF RED BLOOD CELLS TO BE THE CAUSE OF THE BLOCKAGE. AFTER THE REPLACEMENT, THE PATIENT'S STATE OF CONSCIOUSNESS HAD IMPROVED.

  Patient problems: Cognitive Changes

  MAUDE report 11251633 ↗
• MalfunctionJan 27, 2021Mechanical Jam; Mechanical Jam

  INFORMATION WAS RECEIVED REGARDING A PATIENT IMPLANTED WITH A STRATA VALVE. IT WAS REPORTED THAT IT WAS IMPOSSIBLE TO ADJUST THE VALVE, DESPITE MULTIPLE ATTEMPTS. THE DEVICE WAS REPLACED WITH A VALVE OF THE SAME TIME WHICH WORKED AS INTENDED, AND THE PATIENT STATUS IS ALIVE - NO INJURY. IT WAS NOTED THAT THE PHYSICIAN HAS A LOT OF EXPERIENCE WITH USING THE VALVES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11238664 ↗
• InjuryDec 18, 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: Hydrocephalus

  MAUDE report 11037240 ↗
• MalfunctionNov 20, 2020Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED A LEAK WAS DISCOVERED NEAR THE DISTAL END OF THE VALVE DURING THE SURGICAL PROCEDURE. ANOTHER VALVE WAS USED IN ITS PLACE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10880540 ↗
• MalfunctionNov 10, 2020Fluid/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; No Known Impact Or Consequence To Patient

  MAUDE report 10817814 ↗
• InjuryOct 20, 2020Complete Blockage; Complete Blockage

  IT WAS REPORTED THE SHUNT SYSTEM WAS NOT SMOOTH, AND THE VALVE WAS BLOCKED. THE SHUNT SYSTEM AND VALVE WAS REPLACED WITH A NEW ONE. THE PATIENT'S MEDICAL HISTORY WAS HYDROCEPHALUS.

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

  MAUDE report 10708301 ↗
• MalfunctionAug 13, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE VALVE WAS DEFECTIVE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10403417 ↗
• InjuryJul 1, 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: Therapeutic Effects, Unexpected

  MAUDE report 10217748 ↗
• MalfunctionApr 16, 2020Fluid/Blood Leak; Fluid/Blood Leak

  ADDITIONAL INFORMATION RECEIVED REPORTED THAT THERE WERE NO EXTERNAL FACTORS THAT COULD HAVE LED TO THE ISSUE. THE VALVE WENT STRAIGHT FROM THE STERILE CORE INTO THE ROOM AND THEN ONTO THE BACK TABLE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9969819 ↗
• InjuryMar 6, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THE PATIENT WAS IMPLANTED WITH A VENTRICULOPERITONEAL SHUNT. THE PATIENT DEVELOPED A FEVER 3 DAYS AFTER THE SURGERY AND WAS TREATED CONSERVATIVELY WITH ANTIBIOTICS BUT FAILED TO ACHIEVE THE EXPECTED EFFECT. IT WAS THOUGHT THAT THERE MIGHT BE A SHUNT INFECTION. THE SHUNT WAS EXPLANTED, AND THE CORRESPONDING TREATMENT MEASURES WOULD BE TAKEN ACCORDING TO THE SPECIFIC SITUATION OF THE PATIENT. THE PATIENT'S STATUS AT THE TIME OF THE REPORT WAS ALIVE - WITH INJURY.

  Patient problems: Fever; Unspecified Infection

  MAUDE report 9799983 ↗
• InjuryFeb 7, 2020Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT AFTER IMPLANTATION OF THE ADJUSTABLE VALVE, AWARENESS OF THE PATIENT HAD BEEN STARTED TO BE DISORIENTED. IN ORDER TO SOLVE THE PROBLEM, MULTIPLE PRESSURE LEVEL ADJUSTMENTS HAD BEEN DONE, AND THE PATIENT HAD BEEN TRACKED FOR A WHILE. IT WAS SEEN THAT THE VENTRICLES OF THE PATIENT DID NOT GET SMALLER, AND AS A RESULT OF THIS, THE PHYSICIAN DECIDED THAT THE SHUNT WAS NOT DRAINING CEREBROSPINAL FLUID. THE DEVICE WAS REPLACED WITH A NEW ONE. THE PATIENT'S MEDICAL HISTORY WAS MASS OPERATED, HYDROCEPHALUS, AND THEIR STATUS AT THE TIME OF THE REPORT WAS ALIVE - NO INJURY.

  Patient problems: Confusion/ Disorientation; Therapeutic Effects, Unexpected

  MAUDE report 9683894 ↗
• MalfunctionJan 31, 2020Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT WHEN THE VALVE WAS TESTED, SALINE DID NOT FLOW OUT FROM THE PERITONEAL END WHEN THE SURGEON LIFTED UP THE VENTRICULAR CATHETER, WHICH WAS DIPPED INSIDE THE SALINE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9655961 ↗
• MalfunctionJan 29, 2020Fluid/Blood Leak; Appropriate Device Problem Term/Code Not Available; Fluid/Blood Leak; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT DURING THE SURGERY, THE PATIENT'S DRAINAGE WAS ABNORMAL, AND THE DOCTOR SUSPECTED THAT THE VALVE WAS LEAKING. THE VALVE WAS REPLACED WITH ANOTHER ONE OF THE SAME MODEL. THE PATIENT'S STATUS AT THE TIME OF THE REPORT WAS ALIVE-NO INJURY. 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 9644154 ↗
• MalfunctionJan 23, 2020Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED DURING THE VENTRICULOPERITONEAL SHUNT SURGERY, THE DOCTOR SQUEEZED THE VALVE AND FOUND CEREBROSPINAL FLUID LEAKAGE BETWEEN THE VALVE RESERVOIR AND THE BASE. THIS RESULTED IN A PROCEDURE DELAY OF 30 MINUTES. THE VALVE WAS REPLACED WITH THE SAME MODEL TO COMPLETE THE SURGERY. THE PATIENT'S MEDICAL HISTORY WAS HYDROCEPHALUS. THEIR STATUS AT THE TIME OF THE REPORT WAS ALIVE-NO INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9622143 ↗
• MalfunctionJan 23, 2020Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT AFTER THE VALVE WAS IMPLANTED, THE DOCTOR FOUND THAT THE VALVE WAS LEAKING WHEN PRESSING THE RESERVOIR TO DRAIN CEREBROSPINAL FLUID. IT WAS NOTED THAT THE CEREBROSPINAL FLUID COULD NOT BE REMOVED FROM THE ABDOMINAL CAVITY SMOOTHLY. BEFORE IMPLANTATION, THE VALVE WAS CHECKED FOR PATENCY, AND AT THE TIME, THE VALVE WAS UNBLOCKED. THE SUTURE USED AT THE CONNECTION BETWEEN THE VALVE AND THE CATHETER TO FIRMLY FIX. NO SHARP OBJECT WAS USED TO TRAP THE VALVE DURING THE SURGERY. THE VALVE WAS REPLACED WITH A NEW ONE, AND THE SURGERY WAS COMPLETED SMOOTHLY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9621998 ↗
• InjuryJan 21, 2020Break; Fluid/Blood Leak; Break; Fluid/Blood Leak

  IT WAS REPORTED THAT THE VALVE WAS CONNECTED IN THE PATIENT TO THE VENTRICLE AND ABDOMINAL CATHETER. IT WAS THEN FOUND THAT THE VALVE WAS DAMAGED/BROKEN AND LEAKING. AS A RESULT, THE SURGERY COULD NOT BE CARRIED OUT, AND ALL THE DEVICES WERE REMOVED. IT WAS STATED THAT THERE WAS A PROCEDURE DELAY OF 60 MINUTES. THE SKULL WAS CLOSED, AND THEY WERE AWAITING BACK UP PRODUCTS FOR SURGERY AGAIN. THE PATIENT'S STATUS AT THE TIME OF THE REPORT WAS ALIVE-NO INJURY. ADDITIONAL INFORMATION RECEIVED STATED THAT THE PATIENT HAD AN ADDITIONAL SURGERY TO IMPLANT ANOTHER DEVICE ON A DIFFERENT DATE. IT WAS INDICATED THAT 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 9611609 ↗
• MalfunctionJan 17, 2020Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT DOCTOR USED THE VENTRICLE SHUNT TUBE TO PERFORM THE INFUSION; HOWEVER, AFTER THE INFUSION, THE VALVE HAD BUBBLES. THE BUBBLES COULDN'T BE MOVED OUT, AND THE VALVE COULD BE USED NORMALLY. THE VALVE WAS REPLACED WITH ANOTHER ONE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9603284 ↗
• MalfunctionJan 10, 2020Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT THE PATIENT WAS IMPLANTED WITH AN ADJUSTABLE ANTI-SIPHON VALVE ON (B)(6) 2020 DUE TO SUDDENLY DEVELOPING HYDROCEPHALUS AFTER A CAR ACCIDENT AND TRAUMA. DURING THE SURGERY, NORMALLY THE VENTRICULAR AND CELIAC DUCT CATHETERS ARE CONNECTED; HOWEVER, AFTER PRESSING THE VALVE RESERVOIR, A SMALL AMOUNT OF CEREBROSPINAL FLUID LEAKED AT THE END OF THE VALVE. THE VALVE WAS REPLACED WITH A NEW ONE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9575570 ↗
• MalfunctionDec 26, 2019Break; Break

  IT WAS REPORTED THAT THE DOCTOR FOUND THAT THE BASE OF THE VALVE WAS PARTIALLY BROKEN DURING THE SURGERY OF THE VENTRICULOPERITONEAL SHUNT AND COULD NOT BE USED. THE VALVE WAS REPLACED WITH A NEW ONE TO CONTINUE THE SURGERY. 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 9519945 ↗
• MalfunctionDec 19, 2019Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT THE PATIENT UNDERWENT VENTRICULOPERITONEAL SHUNT SURGERY ON (B)(6)2019. AFTER PRE-PERFUSION OF THE VALVE BEFORE THE SURGERY, IT WAS FOUND THAT WATER LEAKED FROM THE ANTI-SIPHON CHAMBER. THE VALVE WAS REPLACED WITH ANOTHER ONE. IT WAS NOTED THAT THIS RESULTED IN A 60 MINUTE PROCEDURE DELAY. THE PATIENT STATUS AT THE TIME OF THE REPORT WAS ALIVE-NO INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9492293 ↗
• MalfunctionDec 9, 2019Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THE PATIENT SUFFERED A TRAUMATIC INJURY DUE TO A CAR ACCIDENT AND DEVELOPED HYDROCEPHALUS. ON DECEMBER 4, THE PATIENT WAS IMPLANTED WITH AN ADJUSTABLE ANTI-SIPHON SHUNT. INTRAOPERATIVELY, THE VENTRICLE END CATHETER AND ABDOMINAL CATHETER WERE CONNECTED NORMALLY. AFTER PRESSING THE VALVE RESERVOIR, A SMALL AMOUNT OF CEREBROSPINAL FLUID WAS FOUND AT THE END OF THE VALVE. THE VALVE WAS REPLACED WITH A NEW ONE AT THE DOCTOR'S REQUEST. 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 9439419 ↗
• InjuryDec 9, 2019Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THE PATIENT WAS IMPLANTED WITH AN ADJUSTABLE ANTI-SIPHON SHUNT ON (B)(6) 2019 DUE TO EXCESSIVE CEREBROSPINAL FLUID. ONE WEEK AFTER SURGERY, CEREBROSPINAL FLUID COULD NOT BE DRAINED, AND THE VALVE WAS BLOCKED. THE DIRECTOR ADVISED THAT THE VENTRICULAR CATHETER SHOULD NOT BE PULLED OUT OF THE VENTRICLE TO AVOID A POSSIBLE CEREBRAL HEMORRHAGE. A SECOND IMPLANT WAS PERFORMED 20 DAYS AFTER THE FIRST SURGERY TO EXPLANT AND IMPLANT A NEW VALVE AND PERITONEAL CATHETER. THE ORIGINAL VENTRICULAR CATHETER WAS CUT OFF, AND THE INTERFACE WAS LIGATED DIRECTLY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9439054 ↗
• MalfunctionNov 11, 2019Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THE PATIENT SUFFERED FROM A CAR ACCIDENT AND SUDDEN HYDROCEPHALUS ON (B)(6) 2019. IT WAS STATED THAT DURING THE SURGERY, WHEN THE PERITONEAL CATHETER WAS CONNECTED TO THE VALVE, IT WAS FOUND THAT THE END OF THE VALVE WAS LEAKING CEREBROSPINAL FLUID. THE VALVE WAS REPLACED WITH A NEW ONE OF THE SAME MODEL.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9304908 ↗

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