Strata® 27819Recalls & reported problems

Summary

The FDA's MAUDE database contains 38 adverse event reports that list this exact device (DI 00763000027391), received between Nov 9, 2020 and Jun 11, 2026 — classified as 6 injuries, 32 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (17 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 38 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 11, 2026Fluid/Blood Leak

  MEDTRONIC RECEIVED INFORMATION REGARDING AN ADJUSTABLE SHUNT. IT WAS REPORTED THAT AFTER THE PRODUCT WAS OPENED, FLUID LEAKED FROM THE ABDOMINAL/PERITONEAL END. THE PRODUCT WAS REPLACED BY ANOTHER MANUFACTURER'S PRODUCT TO COMPLETE THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25473021 ↗
• MalfunctionApr 30, 2026Break; Fracture

  MEDTRONIC RECEIVED INFORMATION REGARDING AN ADJUSTABLE VALVE. IT WAS REPORTED THAT WHEN THE IMPLANTATION PROCEDURE WAS NEAR COMPLETION, THE PHYSICIAN IDENTIFIED A FRACTURE OF THE ANTI-SIPHON CHAMBER. THE DEVICE WAS REMOVED AND REPLACED WITH A NEW PRODUCT. THERE WAS A PROCEDURE DELAY OF 20 MINUTES. THE PATIENT'S STATUS AT THE TIME OF THE REPORT WAS ALIVE-NO INJURY. THE PATIENT'S MEDICAL HISTORY WAS HYPERTENSION AND HYDROCEPHALUS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25043755 ↗
• MalfunctionJan 28, 2026Break; Fracture

  MEDTRONIC RECEIVED INFORMATION REGARDING A SHUNT. IT WAS REPORTED THAT DURING THE PROCEDURE, IT WAS FOUND THAT THE STYLET HAD NO TIP, AND THE PROCEDURE COULD NOT BE COMPLETED SMOOTHLY. A BACK UP KIT WAS URGENTLY OPENED TO COMPLETE THE PROCEDURE. THERE WAS A PROCEDURE DELAY OF 20 MINUTES. THE PATIENT'S STATUS WAS ALIVE- NO INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24199519 ↗
• MalfunctionJan 22, 2026Break; Fluid/Blood Leak; Fracture

  MEDTRONIC RECEIVED INFORMATION REGARDING AN ADJUSTABLE SHUNT. IT WAS REPORTED THAT ON (B)(6) 2026, THE PATIENT UNDERWENT A VENT RICULOPERITONEAL SHUNT PROCEDURE. DURING THE SURGERY, THE SURGEON NOTICED THAT WHEN INJECTING WATER INTO THE CEREBROSPINAL FLUID SHUNT AND ITS ACCESSORIES, THE VALVE AND THE PERITONEAL END TUBING WALL SHOWED A FRACTURE AT THE VALVE'S END. THE FRACTURE CAUSED WATER LEAKAGE. UPON DISCOVERING THIS ISSUE, THE SURGEON IMMEDIATELY CEASED USING THE PRODUCT. THERE WAS A PROCEDURE DELAY OF 30 MINUTES. THE PROCEDURE WAS COMPLETED WITH BACK UP PRODUCTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24144986 ↗
• MalfunctionJun 25, 2025Break; Fluid/Blood Leak; Fracture; Break; Fluid/Blood Leak; Fracture

  MEDTRONIC RECEIVED INFORMATION REGARDING AN ADJUSTABLE VALVE. IT WAS REPORTED THAT THE PATIENT DEVELOPED SECONDARY HYDROCEPHALUS AND UNDERWENT RIGHT VENTRICULOPERITONEAL SHUNT SURGERY. AFTER THE VALVE WAS CONNECTED, IT WAS FOUND THAT THE RESERVOIR WAS DAMAGED AND LEAKING. THE VALVE WAS REPLACED IMMEDIATELY. THE PATIENT'S STATUS AT THE TIME OF THE REPORT WAS ALIVE-NO INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22327168 ↗
• InjuryJun 13, 2025Infusion or Flow Problem; Mechanical Jam; Infusion or Flow Problem; Mechanical Jam

  ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT HAS BEEN IN A COMA.

  Patient problems: Coma; No Clinical Signs, Symptoms or Conditions

  MAUDE report 22205281 ↗
• MalfunctionJun 10, 2025Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  ADDITIONAL INFORMATION RECEIVED REPORTED THAT IT WAS UNKNOWN WHAT THE FOREIGN MATERIAL WAS INSIDE THE VALVE. AFTER OPENING THE PACKAGE, THE FOREIGN MATERIAL WAS FOUND AND IT WAS IMPOSSIBLE TO DETERMINE WHAT THE INGREDIENTS WERE. THE VALVE WAS NOT ATTEMPTED TO BE USED OR IMPLANTED AFTER THE FOREIGN MATERIAL WAS DISCOVERED, AND DIRT MAY HAVE CONTAMINATED IT DURING TRANSPORTATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22176044 ↗
• MalfunctionDec 30, 2024Complete Blockage; Complete Blockage

  MEDTRONIC RECEIVED INFORMATION REGARDING AN ADJUSTABLE VALVE. IT WAS REPORTED THAT DURING THE SURGERY, THE DOCTOR FOUND THAT THE CATHETER WAS NOT UNOBSTRUCTED AT THE TAIL END AFTER CONNECTING IT TO THE VALVE. AFTER THE VALVE WAS PULLED OUT, IT WAS FOUND THAT THE VALVE WAS BLOCKED. THE VALVE WAS REPLACED WITH A NEW ONE FOR THE SURGERY. THERE WAS A PROCEDURE DELAY OF 30 MINUTES. THE PATIENT'S STATUS WAS ALIVE-NO INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21034297 ↗
• MalfunctionJul 22, 2024Break; Fracture; Break; Fracture

  MEDTRONIC RECEIVED INFORMATION REGARDING AN ADJUSTABLE SHUNT. IT WAS REPORTED THAT ON (B)(6) 2024, WHEN THE DOCTOR USED THE CEREBROSPINAL FLUID SHUNT TUBE DURING THE SURGERY, THE DOCTOR DID A PATENCY INSPECTION AND FOUND THAT THE PRODUCT WAS DAMAGED. THE DEVICE WAS REPLACED WITH A NEW ONE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19793129 ↗
• MalfunctionJun 20, 2024Fluid/Blood Leak; Fluid/Blood Leak

  MEDTRONIC RECEIVED INFORMATION REGARDING AN ADJUSTABLE VALVE. IT WAS REPORTED ON APRIL 22, 2024, THE DOCTOR DISCOVERED THAT THE VALVE WAS LEAKING LIQUID WHILE PERFORMING A VENTRICULAR PERITONEAL SHUNT. THE VALVE WAS REPLACED WITH THE SAME PRODUCT TO ENSURE SMOOTH SURGERY. THE PATIENT'S STATUS AT THE TIME OF THE REPORT WAS ALIVE-NO INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19575352 ↗
• MalfunctionJun 20, 2024Fluid/Blood Leak; Fluid/Blood Leak

  MEDTRONIC RECEIVED INFORMATION REGARDING AN ADJUSTABLE VALVE. IT WAS REPORTED ON APRIL 27, 2024, DURING A VENTRICULAR PERITONEAL SURGERY, THE DOCTOR DISCOVERED THAT THE VALVE WAS LEAKING LIQUID. THE VALVE WAS REPLACED WITH THE SAME PRODUCT TO ENSURE SMOOTH SURGERY. THE PATIENT'S STATUS AT THE TIME OF THE REPORT WAS ALIVE-NO INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19575219 ↗
• MalfunctionMay 23, 2024Fluid/Blood Leak; Fluid/Blood Leak

  MEDTRONIC RECEIVED INFORMATION REGARDING AN ADJUSTABLE VALVE. IT WAS REPORTED THAT ON (B)(6) 2024, DURING THE VALVE PATENCY TEST BEFORE IMPLANTATION, LEAKAGE FROM THE ANTI-SIPHON CHAMBER WAS FOUND. THE VALVE WAS REPLACED WITH A NEW ONE. THERE WAS A PROCEDURE DELAY OF 90 MINUTES. THE PATIENT HAD NO INFECTIOUS DISEASES. THE PATIENT'S DISEASE WAS IDIOPATHIC NORMAL PRESSURE HYDROCEPHALUS. THE PATIENT'S CONDITION WAS STABLE, AND THE SURGICAL EFFECT WAS SATISFACTORY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19381809 ↗
• MalfunctionApr 30, 2024Fluid/Blood Leak; Fluid/Blood Leak

  MEDTRONIC RECEIVED INFORMATION REGARDING AN ADJUSTABLE SHUNT. IT WAS REPORTED THAT WHEN THE SHUNT VALVE WAS IMPLANTED, IT WAS FOUND THE THE VALVE WAS LEAKING. IT WAS REPLACED WITH A NEW BACKUP PRODUCT. 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 19212453 ↗
• MalfunctionApr 29, 2024Disconnection; Loose or Intermittent Connection; Device Dislodged or Dislocated; Disconnection; Loose or Intermittent Connection; Device Dislodged or Dislocated

  MEDTRONIC RECEIVED INFORMATION REGARDING AN ADJUSTABLE VALVE. IT WAS REPORTED DURING THE SURGERY WHEN THE PRODUCT WAS OPENED, IT WAS FOUND THAT THE ABDOMINAL END CONNECTION WAS LOOSE/DETACHED. THE DEVICE WAS REPLACED WITH A NEW ONE. THERE WAS A PROCEDURE DELAY OF 10 MINUTES. THE PATIENT'S STATUS AT THE TIME OF THE REPORT WAS ALIVE-NO INJURY. THE PATIENT'S MEDICAL HISTORY WAS INTRACRANIAL ANEURYSM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19201143 ↗
• MalfunctionMar 20, 2024Fluid/Blood Leak; Fluid/Blood Leak

  MEDTRONIC RECEIVED INFORMATION REGARDING AN ADJUSTABLE VALVE. IT WAS REPORTED THAT THE HEALTHCARE PROFESSIONAL (HCP) WAS USING THE PRODUCT AND FOUND THAT THE VALVE WAS LEAKING. THE DEVICE WAS REPLACED WITH A BACKUP PRODUCT OF THE SAME MODEL. THE PATIENT'S STATUS WAS ALIVE-NO INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18940988 ↗
• MalfunctionMar 14, 2024Break; Fluid/Blood Leak; Fracture; Break; Fluid/Blood Leak; Fracture

  MEDTRONIC RECEIVED INFORMATION REGARDING A SHUNT. WHEN THE SHUNT TUBE WAS OPENED FOR TESTING, IT WAS FOUND THAT THE RESERVOIR BAG WAS DAMAGED AND LEAKING. THE DEVICE WAS NOT IMPLANTED. THERE WAS NO IMPACT TO PATIENT OUTCOME. A DIFFERENT DEVICE WAS USED AND THE ISSUE WAS RESOLVED. IT WAS CONFIRMED THAT THE ISSUE ONLY OCCURRED WITH ONE PRODUCT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18903541 ↗
• MalfunctionJan 31, 2024Infusion or Flow Problem; Infusion or Flow Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING AN ADJUSTABLE VALVE. IT WAS REPORTED THAT DURING THE SURGERY, THE SURGEON TESTED THE PATENCY OF THE VALVE BEFORE IMPLANTATION AND FOUND THAT THE DRAINAGE OF THE VALVE WAS NOT SMOOTH. THERE WAS A PROCEDURE DELAY OF 30 MINUTES. THE VALVE WAS REPLACED WITH A NEW ONE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18614749 ↗
• MalfunctionNov 16, 2023Break; Fracture; Break; Fracture

  MEDTRONIC RECEIVED INFORMATION REGARDING AN ADJUSTABLE SHUNT. IT WAS REPORTED THAT THE ANTI-SIPHON CHAMBER WAS DEFORMED. THE DAMAGE WAS FOUND UPON DISASSEMBLY, SO A NEW PRODUCT WAS OPENED FOR IMPLANTATION WHICH DELAYED SOME OPERATION TIME. THE PATIENT'S STATUS AT THE TIME OF THE REPORT WAS ALIVE-NO INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18148885 ↗
• MalfunctionOct 26, 2023Break; Fracture; Break; Fracture

  MEDTRONIC RECEIVED INFORMATION REGARDING AN ADJUSTABLE SHUNT. IT WAS REPORTED THAT DURING THE SURGERY, A CRACK WAS DISCOVERED ON THE VALVE. THE PROCEDURE WAS COMPLETED WITH BACKUP PRODUCTS. THE PATIENT'S STATUS WAS ALIVE-NO INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18010942 ↗
• InjuryOct 12, 2023Break; Fluid/Blood Leak; Fracture; Break; Fluid/Blood Leak; Fracture

  MEDTRONIC RECEIVED INFORMATION REGARDING A SHUNT AND CATHETER USED DURING A PROCEDURE. IT WAS REPORTED THAT ONE MONTH AFTER THE PATIENT WAS IMPLANTED WITH THE SHUNT SYSTEM, THERE WAS FLUID ACCUMULATION FOUND NEAR THE VALVE. THE DOCTOR THOUGHT THE VALVE AND TUBE WERE DETACHED. HOWEVER, WHEN OPENED IT AGAIN, IT WAS DISCOVERED THAT THE VALVE WAS LEAKING FLUID. THE SHUNT AND CATHETER WERE REPLACED. IT WAS NOTED THE PRODUCT WAS DAMAGED. THE PATIENT'S STATUS AT THE TIME OF THE REPORT WAS ALIVE-NO INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17920000 ↗
• MalfunctionOct 11, 2023Infusion or Flow Problem; Infusion or Flow Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A SHUNT. IT WAS REPORTED THAT AFTER THE PATIENT WAS IMPLANTED WITH A HYDROPHILIC-COATED PRESSURE-ADJUSTABLE SHUNT TUBE, THE SHUNT WAS NOT SMOOTH. THE SHUNT TUBE WAS REPLACED WITH PRODUCTS OF THE SAME MODEL. THE PATIENT'S STATUS WAS ALIVE-NO INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17911973 ↗
• InjurySep 13, 2023Fluid/Blood Leak; Fluid/Blood Leak

  MEDTRONIC RECEIVED INFORMATION REGARDING A HYDROCEPHALUS VALVE. IT WAS REPORTED THAT ON (B)(6) 2023, AFTER IMPLANTING THE CEREBROSPINAL FLUID SHUNT, THE SURGEON DID A PASS TEST AND FOUND THAT THE VALVE WAS LEAKING. THE SHUNT 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 17736092 ↗
• MalfunctionJul 27, 2023Fluid/Blood Leak; Fluid/Blood Leak

  MEDTRONIC RECEIVED INFORMATION REGARDING A SHUNT THAT WAS USED DURING A PROCEDURE. IT WAS REPORTED THAT THE SITE FOUND FLUID LEAKAGE FROM THE VALVE AND THE ABDOMINAL CONNECTION TUBE DURING USE. THERE WAS NO REPORTED DELAY TO THE PROCEDURE. PATIENT IMPACT INFORMATION WAS NOT PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17405706 ↗
• MalfunctionJul 26, 2023Fluid/Blood Leak; Fluid/Blood Leak

  MEDTRONIC RECEIVED INFORMATION REGARDING A SHUNT. IT WAS REPORTED THAT BEFORE IMPLANTATION, THE DOCTOR USED THE CSF SHUNT TO DO A PATENCY TEST. THERE WAS FLUID LEAKING. THERE WAS NO REPORTED IMPACT TO PATIENT OUTCOME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17397348 ↗
• MalfunctionJul 12, 2023Complete Blockage; Complete Blockage

  WHEN THE PATENCY OF THE VALVE WAS FOUND TO BE NOT ACCEPTABLE THE VALVE WAS REPLACED AND THE PATIENT WAS CLOSED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17306650 ↗

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