Delta® 27219-5 (UDI 00763000030971)Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00763000030971), received between Sep 3, 2021 and Dec 10, 2025 — classified as 2 injuries, 5 malfunctions.

The most frequently reported specific device problem is “Infusion or Flow Problem” (3 reports).

5 other recalls cover devices cleared under the same FDA submission (K902783); 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• InjuryDec 10, 2025Infusion or Flow Problem; Infusion or Flow Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A VALVE. IT WAS REPORTED THAT THE VALVE WAS IMPLANTED ON (B)(6) 2025. THE PATIENT WENT BACK IN FOR A REVISION SURGERY ON (B)(6) 2025. THE SURGEON STATED THAT THE VALVE WAS DEFECTIVE AND NOT PROPERLY FLOWING. THE SURGERY REPLACED ALL COMPONENTS OF THE SHUNT SYSTEM WITH NEW PARTS. NO ADVERSE EVENTS WITH THE PATIENT HAVE BEEN REPORTED FROM THE SURGEON/FACILITY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23766965 ↗
• MalfunctionAug 15, 2024Complete Blockage; Complete Blockage

  MEDTRONIC RECEIVED INFORMATION REGARDING A VALVE. IT WAS REPORTED THAT THE DOCTOR HAD A VALVE FAILURE ON A PATIENT THE MORNING OF THE REPORTED EVENT. ACCORDING TO THE DOCTOR, THERE WAS ZERO FLOW THROUGH THE VALVE. THE REPORTED ISSUE OCCURRED PRIOR TO IMPLANTATION AND WAS NEVER IMPLANTED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19989931 ↗
• MalfunctionMay 14, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION REGARDING A VALVE. IT WAS REPORTED THAT THE VALVE THAT WAS PLACED IN JANUARY WAS REMOVED THE PREVIOUS NIGHT BECAUSE IT HAD STOPPED WORKING. THE VALVE WAS REPLACED WITH ANOTHER ONE, HOWEVER, IT WAS FOUND TO BE DEFECTIVE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19309738 ↗
• MalfunctionFeb 2, 2024Infusion or Flow Problem; Infusion or Flow Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A VALVE. IT WAS REPORTED THAT THE VALVE WAS IMPLANTED AND ATTACHED TO THE DISTAL CATHETER AND TEST IN VIVO WITH A STANDARD FLUID COLUMN MANOMETER. THE FLUID COLUMN RAN DOWN BRISKLY BUT STOPPED AT A BACK PRESSURE OF 29CM OF WATER. THE VALVE WAS FLUSHED AND ANOTHER FLUID COLUMN WAS CHECKED, WITH THE SAME RESULTS, NORMAL RUN DOWN WITH A BACK PRESSURE OF 29CM OF WATER. THE VALVE WAS THEN EXPLANTED AND DISCONNECTED FROM THE DISTAL CATHETER AND TEST EX VIVO ON THE BACK TABLE AGAIN WITH THE MANOMETER, WITH THE SAME RESULTS, BACK PRESSURE OF 29 CM H20. A NEW VALVE WAS ACQUIRED, AND IMPLANTED, AND WHEN CHECKED VIA THE MANOMETER, NORMAL FLOW TO THE APPROPRIATE VALVE PRESSURE WAS NOTED. 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 18631125 ↗
• InjuryJun 20, 2023Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION REGARDING A VALVE. IT WAS REPORTED THAT THE DEVICE WAS INSTALLED ON THE PATIENT BUT IT DID NOT WORK. THE DOCTOR DISCONNECTED, RECONNECTED, AND MADE SEVERAL TESTS TO DISCARD THE HYPOTHESIS OF HAVING MADE AN ERROR DURING THE PROCEDURE AND EVEN THEN IT DID NOT WORK. THE SITE USED ANOTHER VALVE AND WHEN IT WAS IMPLANTED THE VALVE HAD NO ISSUE. THERE WAS A 15-30 MINUTE DELAY. THE CHILD'S HYDROCEPHALUS WAS CAUSED BY A COMPLEX MALFORMATION OF THE NERVOUS SYSTEM WITH SEMILOBAR HALOPROSENCEPHALY. TRIED TO DO DVE 6 MONTHS AGO WITH NO SUCCESS.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 17162863 ↗
• MalfunctionJun 9, 2023Break; Fracture; Break; Fracture

  MEDTRONIC RECEIVED INFORMATION REGARDING A PATIENT WITH HYDROCEPHALUS. DURING THE SURGERY TO REPLACE THE PATIENTS SHUNT, THE DOCTOR FOUND THAT THE SHUNT WAS DAMAGED, WITH A HOLE IN IT. DUE TO THE UNAVAILABILITY OF ANY OTHER OPTIONS, THE DOCTOR MADE THE DECISION TO RETAIN THE OLD SHUNT. IT WAS REPORTED THAT THERE WAS NO IMPACT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17098744 ↗
• MalfunctionSep 3, 2021Infusion 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: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12422249 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K902783. One submission often covers many models, so check the product and lot details in each record.

• Z-1115-2021 · Jan 11, 2021 · Open, Classified
  Medtronic Delta CSF (Cerebro Spinal Fluid) -Flow Control Valves for the following CFNs/REF numbers: 24048 - VALVE 24048 DELTA RGL PL 0.5, 24053 - CHAMBER 24053 DELTA, 24147 -
• Z-0873-2021 · Dec 16, 2020 · Open, Classified
  REF 27219-5 X1, Medtronic, Delta Valve, Neonatal, Performance Level 1.5, CE 0344, Sterile EO - Product Usage: Neonatal Delta Snap Shunt Assemblies are components of CSF-Flow Contr
• Z-0872-2021 · Dec 16, 2020 · Open, Classified
  REF 27219-2 X1, Medtronic, Delta Valve, Neonatal, Performance Level 2.0, CE 0344, Sterile EO - Product Usage: Neonatal Delta Snap Shunt Assemblies are components of CSF-Flow Contr
• Z-0871-2021 · Dec 16, 2020 · Open, Classified
  REF 27219-1 X1, Medtronic, Delta Valve, Neonatal, Performance Level 1.0, CE 0344, Sterile EO - Product Usage: Neonatal Delta Snap Shunt Assemblies are components of CSF-Flow Contr
• Z-0398-2014 · Nov 18, 2013 · Terminated
  Medtronic Delta Shunt Assembly Kit with Bioglide Small, Performance Level 1.0, Catalog No. 276201. Delta Shunt Assemblies are designed for use in shunting CSF from the lateral ve