Strata® 42365 (UDI 00763000027711)Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 00763000027711), received between Aug 30, 2021 and May 27, 2026 — classified as 2 injuries, 10 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (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 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 27, 2026Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION REGARDING AN ADJUSTABLE VALVE. IT WAS REPORTED THAT THERE WAS NO FUNCTION. THE PATIENT'S STATUS AT THE TIME OF THE REPORT WAS ALIVE-NO INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25299608 ↗
• MalfunctionMar 17, 2026Complete Blockage

  MEDTRONIC RECEIVED INFORMATION REGARDING AN ADJUSTABLE VALVE. IT WAS REPORTED THAT DURING THE VENTRICULOPERITONEAL PROCEDURE, THE PHYSICIAN TESTED THE PRODUCT AND FOUND THAT THE VALVE WAS OCCLUDED AND UNABLE TO DRAIN FLUID NORMALLY. THE VALVE WAS REPLACED WITH A BACK UP PRODUCT. THERE WAS A PROCEDURE DELAY OF 5 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 24617313 ↗
• InjuryNov 17, 2025Complete Blockage; Complete Blockage

  MEDTRONIC RECEIVED INFORMATION REGARDING AN ADJUSTABLE VALVE/SHUNT. IT WAS REPORTED THAT THE PATIENT UNDERWENT A LUMBAR-PERITONEAL SHUNT PROCEDURE ON (B)(6) 2025. POSTOPERATIVELY, THE CEREBROSPINAL FLUID (CSF) SHUNT FUNCTIONED WELL. HOWEVER, MORE THAN ONE MONTH AFTER SURGERY, HYDROCEPHALUS GRADUALLY WORSENED. THE PATIENT'S BRAIN BONE FLAP AREA WAS OBVIOUSLY BULGING, AND THE PERCUTANEOUS SHUNT PRESSURE PUMP PERCUTANEOUS PUNCTURE IRRIGATION AND ASPIRATION WERE INEFFECTIVE, RESULTING IN AGGRAVATION OF HYDROCEPHALUS. IT WAS SUSPECTED THAT PRODUCTS SUCH AS BLOOD CELLS AND PROTEIN DEGRADATION PRODUCTS IN THE CSF, RESULTING FROM TRAUMATIC INTRACRANIAL HEMORRHAGE, HAD BLOCKED THE ARACHNOID GRANULATIONS, LEADING TO IMPAIRED CSF CIRCULATION AND SUBSEQUENT HYDROCEPHALUS. THE CSF SHUNT TUBE THEN BECAME BLOCKED, RESULTING IN SHUNT FAILURE. ON (B)(6) 2025, A REPEAT SHUNT PROCEDURE WAS PERFORMED.

  Patient problems: Hydrocephalus

  MAUDE report 23568827 ↗
• MalfunctionMay 21, 2024Fluid/Blood Leak; Fluid/Blood Leak

  MEDTRONIC RECEIVED INFORMATION REGARDING AN ADJUSTABLE VALVE FOR HYDROCEPHALUS. IT WAS REPORTED THAT DURING THE SURGERY, IT WAS DISC OVERED THAT THE VALVE RESERVOIR WAS LEAKING LIQUID. THE VALVE WAS REPLACED WITH A NEW ONE, AND THE SURGERY WAS COMPLETED. THE PATIENT'S STATUS AT THE TIME OF THE REPORT WAS ALIVE-NO INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19358302 ↗
• MalfunctionNov 6, 2023Mechanics Altered; Mechanics Altered

  IT WAS REPORTED THAT AFTER THE PATIENT'S SURGERY ON MONDAY, THE GEAR WAS ADJUSTED TO 2.0. THE PATIENT THEN RETURNED TO THE ICU (INTENSIVE CARE UNIT) AND STAYED IN THE ICU FOR 2 DAYS. AFTER THE PATIENT'S CONDITION IMPROVED, THE PATIENT WAS TRANSFERRED TO THE GENERAL WARD. THEN THE PATIENT'S CONDITION DETERIORATED. CONSIDERING INSUFFICIENT DRAINAGE, THE DOCTOR ADJUSTED THE GEAR TO 1.5 ON WEDNESDAY. THEN THE PATIENT'S CONDITION DID NOT IMPROVE ON THURSDAY. AT THIS TIME, THE VALVE PRESSURE WAS MEASURED AND FOUND THAT IT HAD JUMPED TO 2.0. THE MANUFACTURER REPRESENTATIVE (REP) WENT TO ADJUST THE VALVE GEAR TO 1.0 ON FRIDAY MORNING. ON FRIDAY AFTERNOON, THE DOCTOR MEASURED THE PRESSURE AND FOUND THAT THE GEAR AUTOMATICALLY JUMPED TO 1.5. THE REP HAD ADJUSTED THE VALVE GEAR MANY TIMES AND EDUCATED THE DOCTOR ON THE CORRECT PRESSURE ADJUSTMENT METHOD. THE PATIENT'S STATUS WAS ALIVE-NO INJURY.

  Patient problems: Insufficient Information

  MAUDE report 18076400 ↗
• MalfunctionOct 19, 2023Fluid/Blood Leak; Fluid/Blood Leak

  MEDTRONIC RECEIVED INFORMATION REGARDING A VALVE. IT WAS REPORTED THAT THEN DOING A VENTRICULOATRIAL SHUNT, IT WAS DISCOVERED THAT THE VALVE WAS LEAKING, SO A NEW VALVE WAS USED. THE VALVE RESERVOIR BAG HAD A HOLE. THERE WAS A REPORTED DELAY OF 15 MINUTES. THERE WAS NO REPORTED IMPACT TO PATIENT OUTCOME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17966817 ↗
• MalfunctionJun 29, 2023Break; Fluid/Blood Leak; Fracture; Break; Fluid/Blood Leak; Fracture

  MEDTRONIC RECEIVED INFORMATION REGARDING A VALVE. IT WAS REPORTED THAT THE RESERVOIR BAG OF THE VALVE RUPTURED AND LEAKED FLUID. THE DEVICE DID NOT HAVE CONTACT WITH THE PATIENT. THE DEVICE WAS REPLACED AND THE ISSUE WAS RESOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17226576 ↗
• MalfunctionMay 15, 2023Break; Fluid/Blood Leak; Fracture; Break; Fluid/Blood Leak; Fracture

  MEDTRONIC RECEIVED INFORMATION REGARDING A STRATA DEVICE. IT WAS REPORTED THAT THE DOCTOR FOUND THAT THE RESERVOIR BAG RUPTURED AND LEAKED LIQUID DURING THE INTRAOPERATIVE TEST. THE DEVICE WAS REPLACED TO COMPLETE THE PROCEDURE. IT WAS REPORTED THAT THE DEVICE DID NOT CONTACT THE PATIENT AND THERE WAS NO INJURY TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16931312 ↗
• InjuryOct 12, 2022Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION REGARDING A DEVICE THAT WAS PERFORMED ON B)(6) 2022. AFTER A PERIOD OF TIME, THE PRODUCT WAS FOUND TO BE DAMAGED AND WAS REMOVED. THE VALVE WAS REPLACED WITH A NEW ONE. THE PATIENT WAS IMPLANTED WITH THE PRODUCT ON (B)(6) 2022, AFTER WHICH THE PHYSICIAN FOUND INSUFFICIENT DRAINAGE. WHEN REGULATING THE PRESSURE, THE PRESSURE COULD NOT BE REGULARLY REGULATED. WHEN THE DOCTOR PRESSED THE PROXIMAL END SPEED LIMITER, THE FLUID RESERVOIR WAS SQUEEZED, BUT IT COULD NOT BE SQUEEZED DOWN SUCCESSFULLY, INDICATING THAT THE DISTAL END OF THE SHUNT SYSTEM WAS BLOCKED. LATER, IT WAS SURGICALLY TAKEN OUT BY THE SURGEON AND IT WAS FOUND THAT THE DISTAL CATHETER OF THE SHUNT SYSTEM WAS NOT BLOCKED, AND THE BLOCKAGE OCCURRED AT THE LOCATION BELOW THE VALVE RESERVOIR CAPSULE.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 15587290 ↗
• MalfunctionSep 6, 2022Fluid/Blood Leak; Fluid/Blood Leak

  MEDTRONIC RECEIVED INFORMATION REGARDING A VALVE DEVICE BEING USED FOR A VP SHUNT SURGERY. IT WAS REPORTED THAT THE DOCTOR DETECTED A LEAK. AFTER CAREFUL INSPECTION A CRACK WAS FOUND AND THE PRODUCT WAS REQUIRED TO BE REPLACED. THERE WAS A REPORTED DELAY OF TWO MINUTES AND NO REPORTED IMPACT TO PATIENT OUTCOME. THE DEVICE WAS NEVER IMPLANTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15362481 ↗
• MalfunctionNov 23, 2021Fluid/Blood Leak; Fluid/Blood Leak

  MEDTRONIC RECEIVED INFORMATION REGARDING A VALVE USED OUTSIDE OF A PROCEDURE. IT WAS REPORTED THAT DURING THE TEST, AIR CONTINUOUSLY ENTERED THE PRODUCT, AND THE DOCTOR SUSPECTED IT WAS DEFECTIVE. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12863766 ↗
• MalfunctionAug 30, 2021Fluid/Blood Leak; Fluid/Blood Leak

  ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE MATERIAL HAD ALREADY BEEN OPENED AND WAS BEING MANIPULATED FOR IMPLANTATION. THE PATIENT WAS IN OPTIMAL CONDITION AFTER THE PROCEDURE SINCE THE DEFECTIVE VALVE WAS REPLACED BY ANOTHER VALVE WITHOUT INCONVENIENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12388101 ↗

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