Strata® 42866 (UDI 00763000027261)Recalls & reported problems

Summary

The FDA's MAUDE database contains 160 adverse event reports that list this exact device (DI 00763000027261), received between Sep 16, 2020 and Sep 24, 2026 — classified as 1 death, 43 injuries, 116 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (76 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 160 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 24, 2026Infusion or Flow Problem

  Medtronic received information regarding an adjustable shunt. It was reported that after implantation of the flow-diverting device, testing revealed that it was not patent. After an intraoperative replacement with a new product, it became patent. There was a procedure delay of 30 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 50882381 ↗
• InjurySep 10, 2026Break; Fracture; Infusion or Flow Problem

  Medtronic received information regarding an adjustable valve. It was reported the patient underwent ventriculoperitoneal shunt surgery on (b)(6) 2026. The shunt valve was intact intraoperatively, with no abnormalities. On (b)(6) 2026, after the patient¿s condition improved, the patient was transferred to rehabilitation. Physical examination revealed subcutaneous fluid accumulation and poor cerebrospinal fluid drainage. On (b)(6) 2026, ventriculoperitoneal shunt adjustment surgery was performed; the shunt valve was found broken intraoperatively and was replaced.

  Patient problems: Insufficient Information

  MAUDE report 50716935 ↗
• MalfunctionAug 27, 2026Mechanical Jam

  Medtronic received information regarding an adjustable valve. It was reported that further tests were conducted with the programmer, including the use of different equipment confirming that the programmer was functioning correctly. However, the valve was not responding to attempts to change its settings; it remained at the 1.0 setting, even after attempts to switch to other parameters and subsequently return to 0.5. Additional programming attempts were made including applying greater pressure over the valve site but resulted in no change in performance. Potential magnetic field interference was also investigated, but no such issue was identified. A CT scan showed the valve was well-positioned. Furthermore, according to the information received, the device functioned properly for approximately one year following implantation. Thus, the current issue appeared to be specific to the valve's adjustment mechanism, which was failing to respond to programming attempts. The physician raised the possibility of obtaining a replacement valve alone, without needing to replace the ventricular and peritoneal catheters. At present, provided the patient remains clinically stable, the family was som

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50484018 ↗
• MalfunctionJul 6, 2026Fluid/Blood Leak

  MEDTRONIC RECEIVED INFORMATION REGARDING AN ADJUSTABLE VALVE. IT WAS REPORTED THAT THERE WAS LIQUID LEAKAGE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25716083 ↗
• MalfunctionMay 29, 2026Fluid/Blood Leak

  MEDTRONIC RECEIVED INFORMATION REGARDING AN ADJUSTABLE VALVE. IT WAS REPORTED THAT THE IMPLANTATION PROCEDURE WAS SCHEDULED FOR APRIL 17, 2026. AFTER OPENING THE PACKAGE, LIQUID LEAKAGE FROM THE PRODUCT WAS NOTICED. THERE WAS A PROCEDURE DELAY OF 3 MINUTES. 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 25330368 ↗
• MalfunctionMay 20, 2026Break; Fluid/Blood Leak; Fracture

  MEDTRONIC RECEIVED INFORMATION REGARDING AN ADJUSTABLE VALVE. IT WAS REPORTED THAT THE RESERVOIR AT THE FRONT END OF THE VALVE WAS DAMAGED AND LEAKING FLUID. NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25230384 ↗
• InjuryMay 20, 2026Adverse Event Without Identified Device or Use Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING AN ADJUSTABLE SHUNT. IT WAS REPORTED THAT ON (B)(6) 2026, THE PATIENT UNDERWENT A VENTRICULOPERITONEAL SHUNT PROCEDURE DUE TO POST-TRAUMATIC HYDROCEPHALUS. POSTOPERATIVELY, THE PATIENT DEVELOPED A SEVERE INFECTION AND THE IMPLANTED DEVICES WERE SUBSEQUENTLY REMOVED. AFTER ALL CLINICAL INDICATORS MET THE REQUIRED STANDARDS, A REPEAT VENTRICULOPERITONEAL SHUNT PROCEDURE WAS PERFORMED USING NEW DEVICES. THE PATIENT'S STATUS AT THE TIME OF THE REPORT WAS ALIVE-NO INJURY.

  Patient problems: Unspecified Infection

  MAUDE report 25229868 ↗
• MalfunctionMay 14, 2026Infusion or Flow Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING AN ADJUSTABLE VALVE. IT WAS REPORTED THAT ON (B)(6) 2026, DURING A VENTRICULOPERITONEAL SHUNT PROCEDURE, A PATENCY TEST WAS PERFORMED PRIOR TO IMPLANTATION. IT WAS FOUND THAT THE OTHER END HAD POOR PATENCY. AFTER REPEATED TESTING, IT REMAINED NON-PATENT. THE DEVICE WAS REPLACED. THERE WAS A PROCEDURE DELAY OF 10 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 25173371 ↗
• MalfunctionMar 31, 2026Fluid/Blood Leak

  MEDTRONIC RECEIVED INFORMATION REGARDING AN ADJUSTABLE VALVE. IT WAS REPORTED THAT THERE WAS VALVE LEAKAGE IDENTIFIED DURING THE PRE -OPERATIVE PATENCY TESTING OF THE DEVICE. NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24741889 ↗
• MalfunctionMar 18, 2026Fluid/Blood Leak

  MEDTRONIC RECEIVED INFORMATION REGARDING AN ADJUSTABLE VALVE. IT WAS REPORTED THAT ON THURSDAY, (B)(6) 2026, WHILE THE DOCTOR WAS PERFORMING A VENTRICULOPERITONEAL SHUNT PROCEDURE, WATER LEAKAGE WAS FOUND IN THE VALVE. THE VALVE WAS PROMPTLY REPLACED WITH A BACKUP PRODUCT OF THE SAME MODEL, AND THE PROCEDURE 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 24629667 ↗
• MalfunctionMar 16, 2026Infusion or Flow Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING AN ADJUSTABLE VALVE. IT WAS REPORTED THAT THE PHYSICIAN FOUND INTRAOPERATIVELY THAT THE DRAINAGE RATE WAS ABNORMALLY FAST DESPITE THE VALVE PRESSURE BEING SET AT 2.0, RAISING CONCERNS ABOUT POTENTIAL OVER DRAINAGE. THEREFORE, THE PRODUCT WAS REPLACED WITH A NEW ONE. 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 24606675 ↗
• MalfunctionMar 6, 2026Fluid/Blood Leak

  MEDTRONIC RECEIVED INFORMATION REGARDING AN ADJUSTABLE VALVE. IT WAS REPORTED THAT ON (B)(6) 2026, DURING A LATERAL VENTRICULAR-PERITONEAL SHUNT PROCEDURE, THE DOCTOR DISCOVERED LEAKAGE AT THE RESERVOIR SITE OF THE SHUNT VALVE. THE PROCEDURE WAS COMPLETED BY PROMPTLY REPLACING IT WITH A BACKUP PRODUCT. THE PATIENT'S STATUS AT THE TIME OF THE REPORT WAS ALIVE-NO INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24530069 ↗
• InjuryJan 30, 2026Infusion or Flow Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING AN ADJUSTABLE VALVE. IT WAS REPORTED THAT THE DEVELOPED HYDROCEPHALUS AS A SEQUELA OF INTRACEREBRAL HEMORRHAGE AND UNDERWENT VENTRICULOPERITONEAL SHUNT SURGERY ON (B)(6) 2025. AFTER THE SURGERY, THE VENTRICLES BECAME SMALLER AND CONSCIOUSNESS IMPROVED, BUT HYDROCEPHALUS RECURRED A FEW WEEKS LATER. NO CATHETER OBSTRUCTION WAS FOUND UPON INVESTIGATION, AND IT WAS CONSIDERED THAT THE VALVE MIGHT NOT BE FUNCTIONING. ON (B)(6) 2026, THE SURGEON REPLACED THE VALVE WITH A NEW ONE.

  Patient problems: Insufficient Information

  MAUDE report 24220785 ↗
• MalfunctionJan 21, 2026Complete Blockage

  MEDTRONIC RECEIVED INFORMATION REGARDING AN ADJUSTABLE SHUNT. IT WAS REPORTED THAT DURING THE SURGERY, THE DOCTOR FOUND ABNORMAL AND OBSTRUCTED DRAINAGE AFTER CONNECTING THE VALVE AND THE ABDOMINAL CATHETER. AFTER REPLACING THE VALVE AND CATHETER WITH NEW ONES, NORMAL FUNCTION WAS RESTORED. THERE WAS A PROCEDURE DELAY OF 30 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 24130956 ↗
• InjuryJan 15, 2026Infusion or Flow Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING AN ADJUSTABLE VALVE. IT WAS REPORTED THAT THE PATIENT, DUE TO HYDROCEPHALUS CAUSED BY SEQUELAE OF INTRACRANIAL HEMORRHAGE, UNDERWENT VENTRICULOPERITONEAL SHUNT SURGERY ON (B)(6) 2025. POSTOPERATIVELY, THE VENTRICLES REDUCED IN SIZE, AND CONSCIOUSNESS IMPROVED. HOWEVER, A FEW WEEKS LATER, HYDROCEPHALUS REOCCURRED. AFTER RULING OUT CATHETER BLOCKAGE, IT WAS CONSIDERED THAT THE VALVE MIGHT NOT BE FUNCTIONING DUE TO A DRAINAGE FAILURE. A NEW VALVE WAS REPLACED ON (B)(6) 2025.

  Patient problems: Insufficient Information

  MAUDE report 24080033 ↗
• InjuryJan 5, 2026Adverse Event Without Identified Device or Use Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING AN ADJUSTABLE SHUNT. IT WAS REPORTED THAT THE PATIENT HAD A BRAIN BLEED (B)(6) 2025 SHORTLY AFTER THE PLACEMENT ((B)(6) 2025) OF A SHUNT AND HAD TO HAVE THE SHUNT REVISED. THE SURGEON ALLEGEDLY REMOVED THE SHUNT, CLEANED IT OUT, AND THEN RE-IMPLANTED IT. THE PATIENT NOW EXPERIENCED SEIZURE CLUSTERS WHERE THEY STRIKE THE SIDE OF THE THEIR SKULL WHERE THE SHUNT WAS PLACED. ADDITIONAL INFORMATION RECEIVED CLARIFIED THAT THE PATIENT HAD VALVE PAIN WHERE THEY WOULD START PUMMELING THE VALVE WHICH OCCURRED WITHIN THE CONTEXT OF THEIR SEIZURE CLUSTER EVENTS, NOT ALWAYS BUT MOST OFTEN AND AT THE VERY BEGINNING OF THE EVENT. THEN, THE PATIENT WOULD TRY TO DASH ACROSS THE HOUSE (USUALLY USED A WHEELCHAIR AS THEY HAD AN UNSTABLE GAIT). IF NOT AT HOME, TRIED TO BOLT. THIS WAS NOT THEIR TYPICAL BEHAVIOR AT BASELINE: LEFT ARM, LEFT LEG, LEFT FOOT RHYTHMIC SHAKING, STARING, HEAD DROPPING, LOSS OF TONE - FELL OUT OF WHEELCHAIR, EYES TO RIGHT, HEAD TO RIGHT <(>&<)> UP TOWARDS THE SEIZURES. THE SEIZURES WERE GENERALLY FOCAL SEIZURES UNTIL RECENTLY. THE PATIENT HAD A HISTORY OF TONIC CLONIC SEIZURES SINCE BIRTH THOUGH. THEY WERE DIAGNOSED WITH FRONTAL LOBE EPI

  Patient problems: Hematoma; Intracranial Hemorrhage; Pain

  MAUDE report 23960333 ↗
• InjuryDec 17, 2025Mechanics Altered; Mechanics Altered

  MEDTRONIC RECEIVED INFORMATION REGARDING AN ADJUSTABLE VALVE. IT WAS REPORTED THAT THE SURGEON STATED THE VALVE LOST THE REGULATED VALVE, AND THIS LED TO AN EPIDURAL HEMATOMA. THE VALVES WERE REGULATED TO A SPECIFIC VALUE, BUT THE VALVES WERE LOOSING THE REGULATED VALUE. IT WAS NOTED THE PATIENT DID NOT HAVE ANY MRI EXAM. NO INTERVENTION WAS PERFORMED.

  Patient problems: Intracranial Hemorrhage

  MAUDE report 23828865 ↗
• MalfunctionDec 17, 2025Fluid/Blood Leak; Fluid/Blood Leak

  MEDTRONIC RECEIVED INFORMATION REGARDING AN ADJUSTABLE VALVE. IT WAS REPORTED THAT BEFORE IMPLANTATION SURGERY, A ROUTINE PATENCY TEST OF THE PRODUCT REVEALED VALVE LEAKAGE. NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23827510 ↗
• MalfunctionDec 17, 2025Fluid/Blood Leak; Fluid/Blood Leak

  MEDTRONIC RECEIVED INFORMATION REGARDING AN ADJUSTABLE VALVE. IT WAS REPORTED THAT DURING THE SHUNT SURGERY, THE DOCTOR PERFORMED A PATENCY TEST AND FOUND THAT THE VALVE WAS LEAKING. THE VALVE WAS REPLACED WITH A NEW ONE. THE PATIENT'S STATUS AT THE TIME OF THE REPORT WAS ALIVE-NO INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23827174 ↗
• InjuryDec 17, 2025Infusion or Flow Problem; Infusion or Flow Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING AN ADJUSTABLE VALVE. IT WAS REPORTED SEVEN MONTHS AFTER THE SURGERY, THE PATIENT¿S CONDITION WAS NORMAL DURING THE INTERIM PERIOD. RECENTLY, IT WAS FOUND THAT THE VENTRICLES HAD NOT DECREASED IN SIZE, RAISING SUSPICION OF SHUNT MALFUNCTION, SO THE SHUNT WAS REMOVED. THE PATIENT'S STATUS AT THE TIME OF THE REPORT WAS ALIVE, NO INJURY.

  Patient problems: Insufficient Information

  MAUDE report 23827097 ↗
• MalfunctionDec 9, 2025Fluid/Blood Leak; Fluid/Blood Leak

  MEDTRONIC RECEIVED INFORMATION REGARDING AN ADJUSTABLE SHUNT. IT WAS REPORTED THAT ON (B)(6) 2025, A PATIENT UNDERWENT A VENTRI CULOPERITONEAL SHUNT PROCEDURE FOR POST-TRAUMATIC HYDROCEPHALUS. DURING PRE-FILLING OF THE CATHETER WITH NORMAL SALINE, LEAKAGE WAS DETECTED. THE DEVICES WERE SUBSEQUENTLY REPLACED WITH NEW CATHETER AND VALVE. THE PATIENT'S STATUS AT THE TIME OF THE REPORT WAS ALIVE-NO INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23756002 ↗
• MalfunctionNov 18, 2025Break; Fluid/Blood Leak; Fracture; Break; Fluid/Blood Leak; Fracture

  MEDTRONIC RECEIVED INFORMATION REGARDING AN ADJUSTABLE VALVE. IT WAS REPORTED THAT THERE WAS A HOLE IN THE SHUNT; THEREFORE, LEAKING PRIOR TO USE. NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23582274 ↗
• MalfunctionNov 14, 2025Break; Fracture; Break; Fracture

  MEDTRONIC RECEIVED INFORMATION REGARDING AN ADJUSTABLE VALVE. IT WAS REPORTED THAT THE RESERVOIR WAS DAMAGED. THE VALVE WAS REPLACED WITH A NEW ONE. THE PATIENT'S STATUS AT THE TIME OF THE REPORT WAS ALIVE-NO INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23554184 ↗
• MalfunctionNov 7, 2025Fluid/Blood Leak; Fluid/Blood Leak

  MEDTRONIC RECEIVED INFORMATION REGARDING AN ADJUSTABLE VALVE. IT WAS REPORTED THAT THE SURGEON SAID, "IT LEAKED" WHEN THEY PREPARED/TESTED THE VALVE BEFORE AS PER THE INSTRUCTIONS FOR USE (IFU) (TO FILL NORMAL SALINE TO CHECK THE VALVE). NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23496037 ↗
• MalfunctionOct 15, 2025Fluid/Blood Leak; Fluid/Blood Leak

  MEDTRONIC RECEIVED INFORMATION REGARDING AN ADJUSTABLE VALVE. IT WAS REPORTED THAT DURING THE CEREBROSPINAL FLUID SHUNT SURGERY, THE ADJUSTABLE PRESSURE VALVE DEVELOPED A LIQUID LEAK, AND A LARGE AMOUNT OF BLOODY MATERIAL WAS FOUND IN THE RESERVOIR. THE PROCEDURE WAS COMPLETED WITH BACKUP 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 23278741 ↗

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