Strata® 42856 (UDI 00763000027254)Recalls & reported problems

Summary

The FDA's MAUDE database contains 30 adverse event reports that list this exact device (DI 00763000027254), received between Jan 11, 2021 and May 14, 2026 — classified as 16 injuries, 14 malfunctions.

The most frequently reported specific device problem is “Infusion or Flow Problem” (8 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 30 reports, in the reporter's own words as published by the FDA.

• InjuryMay 14, 2026Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION REGARDING AN ADJUSTABLE VALVE. IT WAS REPORTED THAT THE MANUAL AND ELECTRONIC PROGRAMMERS SHOWED THE VALVE TO BE AT A DIFFERENT PRESSURE LEVEL SETTING THAN WHEN CONFIRMING THE PRESSURE LEVEL SETTING WITH X-RAY. THE X-RAYS WERE TAKEN IMMEDIATELY AFTER PROGRAMMING THE PATIENT. IT WAS NOTED THAT THE SURGEON WAS VERY EXPERIENCED WITH THE VALVE AND TRIED PROGRAMMING/CHECKING WITH BOTH THE MANUAL AND ELECTRONIC PROGRAMMERS. THE VALVE WAS EXPLANTED AND REPLACED WITH AN NON-ADJUSTABLE VALVE. THE ORIGINAL SURGERY WAS (B)(6) 2024.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25174436 ↗
• InjuryMar 10, 2026Complete Blockage

  MEDTRONIC RECEIVED INFORMATION REGARDING AN ADJUSTABLE VALVE. IT WAS REPORTED THAT AFTER TWO POSTOPERATIVE PRESSURE ADJUSTMENTS, THE PRESSURE WAS SET TO THE LOWEST LEVEL, AND THE PATIENT DID NOT HAVE LOW INTRACRANIAL PRESSURE, BUT THERE WAS NO CEREBROSPINAL FLUID FLOWING OUT. IT WAS NOTED THIS WAS NOT DUE TO LOW INTRACRANIAL PRESSURE OR TUBE BLOCKAGE. THE SITUATION BECAME NORMAL AFTER THE SHUNT WAS REPLACED. THERE WAS A PROCEDURE DELAY OF 80 MINUTES. THE PATIENT'S STATUS AT THE TIME OF THE REPORT WAS ALIVE-NO INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24556795 ↗
• InjuryFeb 19, 2026Infusion or Flow Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING AN ADJUSTABLE VALVE. IT WAS REPORTED THAT THE VALVE WAS IMPLANT ON (B)(6) 2026, AND THEN ON (B)(6) 2026, THE DOCTOR STATED THAT THE VALVE WAS NOT WORKING BECAUSE THE PATIENT WAS NOT RESPONDING. THE PATIENT PRESENTED SIGNS AND SYMPTOMS OF DECOMPENSATED HYDROCEPHALUS DESPITE HAVING THE PERFORMANCE CHANGED FROM 2 TO 1. IT WAS NOTED THAT THE PATIENT UNDERWENT MULTIPLE VENTRICULAR PUNCTURES UNTIL THIS WAS THE ACHIEVED CONCLUSION. A REVISION SURGERY WAS PERFORMED ON (B)(6) 2026, TO SEE IF THERE COULD BE AN OBSTRUCTION THAT WAS IMPAIRING THE FUNCTIONING OF THE VALVE, AND IT WAS FOUND THAT THERE WAS NONE. A NEW VALVE WAS IMPLANTED OF THE SAME MODEL BUT DIFFERENT BATCH, AND THE PATIENT REACTED WELL AND THE VALVE WORKED PERFECTLY. THE PATIENT'S STATUS AT THE TIME OF THE REPORT WAS ALIVE-NO INJURY.

  Patient problems: Insufficient Information

  MAUDE report 24390161 ↗
• MalfunctionJan 13, 2026Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION REGARDING AN ADJUSTABLE VALVE. IT WAS REPORTED THAT THE VALVE WAS MALFUNCTIONING DURING SETUP. THE PROCEDURE WAS COMPLETED WITH BACK UP PRODUCTS. THE PATIENT'S STATUS AT THE TIME OF THE REPORT WAS ALIVE-NO INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24055302 ↗
• InjuryJan 5, 2026Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION REGARDING AN ADJUSTABLE VALVE. IT WAS REPORTED THAT THE PATIENT HAD A SHUNT REVISION, AND THE DOCTOR DETERMINED THE VALVE WAS NOT FUNCTIONING. THE DOCTOR DID NOT SEE ANY EVIDENCE OF PROTEIN BUILD UP AND COULD DETERMINE NO REASON FOR THE MALFUNCTION. THE VALVE WAS REPLACED WITH A NEW VALVE. THE PATIENT'S MEDICAL HISTORY WAS HYDROCEPHALUS. THE PATIENT'S STATUS AT THE TIME OF THE REPORT WAS ALIVE-NO INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23960690 ↗
• InjuryDec 22, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION REGARDING AN ADJUSTABLE VALVE. IT WAS REPORTED THAT THERE WAS A SHUNT MALFUNCTION. THE SHUNT WAS IMPLANTED ON (B)(6) 2025 AND EXPLANTED ON (B)(6) 2025. THE CURRENT STATUS OF THE PATIENT WAS NOTED AS IN HOUSE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23864249 ↗
• MalfunctionNov 17, 2025Break; Fracture; Break; Fracture

  MEDTRONIC RECEIVED INFORMATION REGARDING AN ADJUSTABLE VALVE. IT WAS REPORTED THAT WHEN CONNECTING THE CATHETER TO THE VALVE, THE CONNECTION BROKE. THE PROCEDURE WAS COMPLETED WITH BACK UP PRODUCTS. THE PATIENT'S STATUS AT THE TIME OF THE REPORT WAS ALIVE-NO INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23568413 ↗
• MalfunctionAug 21, 2025Fluid/Blood Leak; Fluid/Blood Leak

  MEDTRONIC RECEIVED INFORMATION REGARDING AN ADJUSTABLE VALVE. IT WAS REPORTED THAT HYDROCEPHALUS WAS DIAGNOSED PREOPERATIVELY, AND DURING THE VENTRICULOPERITONEAL SHUNT PROCEDURE, THE VALVE WAS FOUND TO BE LEAKING BEFORE INSERTION. A NEW VALVE OF THE SAME MODEL WAS THEN USED, AND THE PROCEDURE CONTINUED. THE PATIENT'S STATUS AT THE TIME OF THE REPORT WAS ALIVE-NO INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22860332 ↗
• InjuryJul 31, 2025Infusion or Flow Problem; Mechanical Jam; Infusion or Flow Problem; Mechanical Jam

  MEDTRONIC RECEIVED INFORMATION REGARDING AN ADJUSTABLE VALVE. IT WAS REPORTED THAT AFTER THE PATIENT'S OPERATION, DURING THE CEREBROSPINAL FLUID PRESSURE REGULATION PROCESS, THE PRESSURE REMAINED VERY HIGH AND COULD NOT BE ADJUSTED DOWN. AFTER EVALUATION BY THE CLINICAL DIRECTOR, IT WAS FOUND THAT THE PRESSURE REGULATING VALVE HAD FAILED. THEN, THROUGH SURGERY, A NEW PRESSURE REGULATING VALVE WAS REPLACED AND THE PRESSURE COULD BE ADJUSTED NORMALLY. THE PATIENT'S STATUS AT THE TIME OF THE REPORT WAS ALIVE-NO INJURY.

  Patient problems: Insufficient Information

  MAUDE report 22674559 ↗
• InjuryJun 3, 2025Infusion or Flow Problem; Infusion or Flow Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING AN ADJUSTABLE VALVE. IT WAS REPORTED THAT THE VALVE WAS IMPLANTED ON (B)(6) 2025 AND INITIALLY SET AT 2, THEN TO 2.5. THE X-RAY SHOWED THE VALVE TO BE SET AT 2.5, AND THE PATIENT'S SYMPTOMS HAD NOT CHANGED. THE PATIENT HAD A NUCLEAR MED SHUNT STUDY THAT SHOWED BRISK RUNOFF, AND AN OPENING PRESSURE OF 10. THE VALVE WAS EXPLANTED.

  Patient problems: Insufficient Information

  MAUDE report 22132080 ↗
• InjuryDec 12, 2024Infusion or Flow Problem; Mechanics Altered; Infusion or Flow Problem; Mechanics Altered

  MEDTRONIC RECEIVED INFORMATION REGARDING A VALVE. IT WAS REPORTED THAT THE VALVE WAS PROGRAMMED AT 0.5, HOWEVER, THE PATIENT OVERDRAINED. THE HEALTHCARE PROFESSIONAL DIALED THE VALVE UP TO 2.5, HOWEVER, THE PATIENT HAD SYMPTOMS OF UNDERDRAINAGE. THE VALVE WAS DIALED TO 2.0, AND THEN THEY TRIED TO LOWER FURTHER TO 1.5, BUT THE VALVE KEPT SPONTANEOUSLY SWAPPING BACK TO 2.0 EVERY TIME THEY WOULD RE-CHECK. THE VALVE WAS EXCHANGED. THE CURRENT STATUS OF THE PATIENT WAS INPATIENT.

  Patient problems: Insufficient Information

  MAUDE report 20912327 ↗
• InjuryNov 14, 2024Infusion or Flow Problem; Insufficient Device Problem Information; Infusion or Flow Problem; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION REGARDING AN ADJUSTABLE VALVE. IT WAS REPORTED THAT THE DOCTOR WAS PERFORMING A SHUNT REVISION AS THEY BELIEVED THERE WAS SOMETHING WRONG WITH THE VALVE. THE VALVE WAS INITIALLY PLACED IN (B)(6) 2020.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20683491 ↗
• MalfunctionApr 29, 2024Mechanical Jam; Mechanical Jam

  MEDTRONIC RECEIVED INFORMATION REGARDING AN ADJUSTABLE VALVE. IT WAS REPORTED THE PATIENT WAS ADMITTED TO THE HOSPITAL DUE TO HYDROCEPHALUS CAUSED BY TUMOR SURGERY. DURING THE VENTRICULOPERITONEAL SHUNT SURGERY, WHEN ADJUSTING THE PRESSURE BEFORE THE OPERATION, IT WAS FOUND THAT THE GEAR POSITION COULD NOT BE ADJUSTED. THE DEVICE WAS REPLACED WITH A NEW ONE, AND THE OPERATION WENT SMOOTHLY. THE PATIENT'S STATUS AT THE TIME OF THE REPORT WAS ALIVE-NO INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19202165 ↗
• InjuryApr 24, 2024Infusion or Flow Problem; Infusion or Flow Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING AN ADJUSTABLE VALVE. IT WAS REPORTED THAT THE PATIENT UNDERWENT "LAPAROSCOPIC VENTRICULOPERITONEAL SHUNT REPOSITIONING" ON (B)(6) 2024. ON (B)(6) 2024, THE PATIENT COMPLAINED THAT THE HEADACHE WORSENED, THE DISTURBANCE OF CONSCIOUSNESS WORSENED, THEY COULD NOT OPEN THEIR EYES, AND THEY HAD CONVULSIONS. REVIEW OF THE HEAD CT COMPARED WITH THE (B)(6) 2024, CT FILM SHOWED HYDROCEPHALUS INCREASED SIGNIFICANTLY THAN BEFORE; CHANGES OCCURRED AFTER VENTRICULAR DRAINAGE, AND THE DENSITY OF THE BRAIN PARENCHYMA AROUND THE RIGHT FRONTAL LOBE DRAINAGE TUBE DECREASED. IT WAS CONSIDERED THAT THE HYDROCEPHALUS WORSENED TO THE POINT WHERE THE PATIENT CONVULSED, THE CONSCIOUSNESS CHANGED, AND AFTER COMMUNICATING WITH THE FAMILY MEMBER, THEY ASKED THE GENERAL SURGERY DEPARTMENT TO CONSULT AND COOPERATE WITH THE EMERGENCY DEPARTMENT IMMEDIATELY TO PLAN A "LAPAROSCOPIC EXPLORATION AND REPOSITIONING OF THE ABDOMINAL END OF THE VENTRICULO-ABDOMINAL DRAINAGE TUBE" TO CHECK THAT THE ORIGINAL SHUNT TUBE AND ACCESSORIES WERE NOT SMOOTH. ON (B)(6) THE PATIENT WAS TRANSFERRED TO THE HOSPITAL FOR TREATMENT. THE SHUNT TUBE AND ACCESSORIES WERE REPLACED.

  Patient problems: Convulsion/Seizure; Headache; Loss of consciousness

  MAUDE report 19172079 ↗
• InjuryOct 31, 2023Complete Blockage; Complete Blockage

  MEDTRONIC RECEIVED INFORMATION REGARDING AN ADJUSTABLE SHUNT. IT WAS REPORTED THAT THE POST-OPERATIVELY, THE SHUNT WAS ABNORMAL AS THE SHUNT TUBE WAS BLOCKED, AND THE VALVE WAS CONSIDERED TO BE BLOCKED. THE SHUNT WAS REPLACED. IT WAS NOTED THE SURGEON REPORTED THAT THE SURGICAL PROCEDURE WAS NORMAL AND NOTHING ELSE WAS KNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18039503 ↗
• MalfunctionOct 27, 2023Mechanical Jam; Mechanical Jam

  MEDTRONIC RECEIVED INFORMATION REGARDING AN ADJUSTABLE VALVE. IT WAS REPORTED THAT THE VALVE WAS UNABLE TO ADJUST THE VALVE'S PRESSURE SETTING PRIOR TO THE CASE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18020725 ↗
• MalfunctionOct 2, 2023Fluid/Blood Leak; Fluid/Blood Leak

  ADDITIONAL INFORMATION RECEIVED REPORTED THAT THERE WAS NO IMPACT TO PATIENT OUTCOME. THERE WAS A PROCEDURE DELAY OF 1 MINUTE. 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 17851083 ↗
• MalfunctionJul 18, 2023Complete Blockage; Complete Blockage

  MEDTRONIC RECEIVED INFORMATION REGARDING A VALVE. IT WAS REPORTED THAT THE VALVE WAS NOT FLUSHING. THEY SWAPPED OUT WITH ANOTHER VALVE. THE DEVICE WAS NEVER IMPLANTED AND CAUSED A 10 MINUTE DELAY TO PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17344331 ↗
• MalfunctionJun 30, 2023Mechanical Jam; Mechanical Jam

  MEDTRONIC RECEIVED INFORMATION REGARDING PROGRAMMABLE VALVES. IT WAS REPORTED THAT THE VALVE WAS OPENED AND PASSED TO THE NURSE TO PROGRAM AHEAD OF IMPLANTATION, BUT THE VALVE WOULD NOT SWITCH SETTINGS. SO IT WAS SET ASIDE AND NOT USED. THIS THEN HAPPENED WITH TWO MORE VALVE FROM THE SAME BATCH. A 4TH VALVE WAS THEN TRIED, THIS TIME FROM A DIFFERENT BATCH, AND IT WORKED AS EXPECTED SO IT WAS IMPLANTED. THERE WAS NO REPORTED PATIENT INVOLVED IN THIS CASE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17237938 ↗
• MalfunctionJun 30, 2023Mechanical Jam; Mechanical Jam

  MEDTRONIC RECEIVED INFORMATION REGARDING PROGRAMMABLE VALVES. IT WAS REPORTED THAT THE VALVE WAS OPENED AND PASSED TO THE NURSE TO PROGRAM AHEAD OF IMPLANTATION, BUT THE VALVE WOULD NOT SWITCH SETTINGS. SO IT WAS SET ASIDE AND NOT USED. THIS THEN HAPPENED WITH TWO MORE VALVE FROM THE SAME BATCH. A 4TH VALVE WAS THEN TRIED, THIS TIME FROM A DIFFERENT BATCH, AND IT WORKED AS EXPECTED SO IT WAS IMPLANTED. THERE WAS NO REPORTED PATIENT INVOLVED IN THIS CASE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17237885 ↗
• MalfunctionJun 30, 2023Mechanical Jam; Mechanical Jam

  MEDTRONIC RECEIVED INFORMATION REGARDING PROGRAMMABLE VALVES. IT WAS REPORTED THAT THE VALVE WAS OPENED AND PASSED TO THE NURSE TO PROGRAM AHEAD OF IMPLANTATION, BUT THE VALVE WOULD NOT SWITCH SETTINGS. SO IT WAS SET ASIDE AND NOT USED. THIS THEN HAPPENED WITH TWO MORE VALVE FROM THE SAME BATCH. A 4TH VALVE WAS THEN TRIED, THIS TIME FROM A DIFFERENT BATCH, AND IT WORKED AS EXPECTED SO IT WAS IMPLANTED. THERE WAS NO REPORTED PATIENT INVOLVED IN THIS CASE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17237864 ↗
• InjuryMay 12, 2023Complete Blockage; Complete Blockage

  MEDTRONIC RECEIVED INFORMATION REGARDING A STRATA VALVE. IT WAS REPORTED THAT THE VALVE WAS MALFUNCTIONING IN THE PATIENT AND WOULD NOT DRAIN. THE VALVE WAS SENT BACK AND SO IT WAS EXPLANTED.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 16919799 ↗
• InjuryJan 13, 2023Infusion or Flow Problem; Mechanical Jam; Infusion or Flow Problem; Mechanical Jam

  THE ISSUE SEEMED TO BE CAUSED BY PRODUCT FAILURE. THE SHUNT WAS REPLACED ON (B)(6) 2023.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16159822 ↗
• InjuryOct 1, 2022Complete Blockage; Complete Blockage

  MEDTRONIC RECEIVED INFORMATION REGARDING A VALVE DEVICE. IT WAS REPORTED THAT THERE WAS NO LIQUOR FLOW IN THE VALVE. THIS RESULTED IN A DELAY OF THE SURGERY. THE VALVE WAS REMOVED AND A NEW ONE WAS INSTALLED.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 15525924 ↗
• MalfunctionJul 25, 2022Infusion or Flow Problem; Infusion or Flow Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A VALVE. IT WAS REPORTED THAT DURING PROCEDURE AND PRIOR TO USE THE VALVE WAS NOT SMOOTH DURING PATENCY TEST. AFTER REPEATED ATTEMPTS TO PRESS THE RESERVOIR BAG, THE FLUID COULD NOT BE DISCHARGED TO THE DISTAL END. THE SITE REPLACED THE VALVE TO PROCEED WITH THE SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15094009 ↗

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