Delta® 27219-1 (UDI 00763000030964)Recalls & reported problems

Summary

The FDA's MAUDE database contains 24 adverse event reports that list this exact device (DI 00763000030964), received between Sep 14, 2020 and Aug 27, 2024 — classified as 24 malfunctions.

The most frequently reported specific device problem is “Device Misassembled During Manufacturing /Shipping” (20 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 24 most recent of 24 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 27, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION REGARDING A VALVE. IT WAS REPORTED THAT THERE WAS AN OUT OF BOX FAILURE. NO PATIENT INJURY OCCURRED, AND THE ONLY DELAY WAS OPENING ANOTHER VALVE FROM A DIFFERENT COMPANY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20076679 ↗
• 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 12422238 ↗
• MalfunctionJan 28, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT IT SEEMED THAT THE VENTRICULAR CONNECTION SITE WAS MUCH SHORTER THAN IT WAS SUPPOSED TO BE. THE FACILITY WAS CURRENTLY CEASING ALL USE OF THE VALVES. ADDITIONAL INFORMATION RECEIVED REPORTED THAT JUST BY LOOKING AT THE VALVE IN THE STERILE PACKAGING, THERE WAS A DISTINCT DIFFERENCE BETWEEN THE TWO CONNECTORS. THE DISTAL CONNECTOR WAS MUCH LONGER THAN THE PROXIMAL CONNECTOR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11243816 ↗
• MalfunctionNov 17, 2020Device Misassembled During Manufacturing /Shipping; Device Misassembled During Manufacturing /Shipping

  IT WAS REPORTED THAT IT SEEMED THAT THE VENTRICULAR CONNECTION SITE WAS MUCH SHORTER THAN IT WAS SUPPOSED TO BE. THE FACILITY WAS CURRENTLY CEASING ALL USE OF THE VALVES. ADDITIONAL INFORMATION RECEIVED REPORTED THAT JUST BY LOOKING AT THE VALVE IN THE STERILE PACKAGING, THERE WAS A DISTINCT DIFFERENCE BETWEEN THE TWO CONNECTORS. THE DISTAL CONNECTOR WAS MUCH LONGER THAN THE PROXIMAL CONNECTOR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10856930 ↗
• MalfunctionNov 17, 2020Device Misassembled During Manufacturing /Shipping; Device Misassembled During Manufacturing /Shipping

  IT WAS REPORTED THAT IT SEEMED THAT THE VENTRICULAR CONNECTION SITE WAS MUCH SHORTER THAN IT WAS SUPPOSED TO BE. THE FACILITY WAS CURRENTLY CEASING ALL USE OF THE VALVES. ADDITIONAL INFORMATION RECEIVED REPORTED THAT JUST BY LOOKING AT THE VALVE IN THE STERILE PACKAGING, THERE WAS A DISTINCT DIFFERENCE BETWEEN THE TWO CONNECTORS. THE DISTAL CONNECTOR WAS MUCH LONGER THAN THE PROXIMAL CONNECTOR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10856873 ↗
• MalfunctionNov 17, 2020Device Misassembled During Manufacturing /Shipping; Device Misassembled During Manufacturing /Shipping

  IT WAS REPORTED THAT IT SEEMED THAT THE VENTRICULAR CONNECTION SITE WAS MUCH SHORTER THAN IT WAS SUPPOSED TO BE. THE FACILITY WAS CURRENTLY CEASING ALL USE OF THE VALVES. ADDITIONAL INFORMATION RECEIVED REPORTED THAT JUST BY LOOKING AT THE VALVE IN THE STERILE PACKAGING, THERE WAS A DISTINCT DIFFERENCE BETWEEN THE TWO CONNECTORS. THE DISTAL CONNECTOR WAS MUCH LONGER THAN THE PROXIMAL CONNECTOR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10856830 ↗
• MalfunctionNov 17, 2020Device Misassembled During Manufacturing /Shipping; Device Misassembled During Manufacturing /Shipping

  IT WAS REPORTED THAT IT SEEMED THAT THE VENTRICULAR CONNECTION SITE WAS MUCH SHORTER THAN IT WAS SUPPOSED TO BE. THE FACILITY WAS CURRENTLY CEASING ALL USE OF THE VALVES. ADDITIONAL INFORMATION RECEIVED REPORTED THAT JUST BY LOOKING AT THE VALVE IN THE STERILE PACKAGING, THERE WAS A DISTINCT DIFFERENCE BETWEEN THE TWO CONNECTORS. THE DISTAL CONNECTOR WAS MUCH LONGER THAN THE PROXIMAL CONNECTOR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10856820 ↗
• MalfunctionNov 17, 2020Device Misassembled During Manufacturing /Shipping; Device Misassembled During Manufacturing /Shipping

  IT WAS REPORTED THAT IT SEEMED THAT THE VENTRICULAR CONNECTION SITE WAS MUCH SHORTER THAN IT WAS SUPPOSED TO BE. THE FACILITY WAS CURRENTLY CEASING ALL USE OF THE VALVES. ADDITIONAL INFORMATION RECEIVED REPORTED THAT JUST BY LOOKING AT THE VALVE IN THE STERILE PACKAGING, THERE WAS A DISTINCT DIFFERENCE BETWEEN THE TWO CONNECTORS. THE DISTAL CONNECTOR WAS MUCH LONGER THAN THE PROXIMAL CONNECTOR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10856753 ↗
• MalfunctionNov 17, 2020Device Misassembled During Manufacturing /Shipping; Device Misassembled During Manufacturing /Shipping

  IT WAS REPORTED THAT IT SEEMED THAT THE VENTRICULAR CONNECTION SITE WAS MUCH SHORTER THAN IT WAS SUPPOSED TO BE. THE FACILITY WAS CURRENTLY CEASING ALL USE OF THE VALVES. ADDITIONAL INFORMATION RECEIVED REPORTED THAT JUST BY LOOKING AT THE VALVE IN THE STERILE PACKAGING, THERE WAS A DISTINCT DIFFERENCE BETWEEN THE TWO CONNECTORS. THE DISTAL CONNECTOR WAS MUCH LONGER THAN THE PROXIMAL CONNECTOR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10856742 ↗
• MalfunctionNov 17, 2020Device Misassembled During Manufacturing /Shipping; Device Misassembled During Manufacturing /Shipping

  IT WAS REPORTED THAT IT SEEMED THAT THE VENTRICULAR CONNECTION SITE WAS MUCH SHORTER THAN IT WAS SUPPOSED TO BE. THE FACILITY WAS CURRENTLY CEASING ALL USE OF THE VALVES. ADDITIONAL INFORMATION RECEIVED REPORTED THAT JUST BY LOOKING AT THE VALVE IN THE STERILE PACKAGING, THERE WAS A DISTINCT DIFFERENCE BETWEEN THE TWO CONNECTORS. THE DISTAL CONNECTOR WAS MUCH LONGER THAN THE PROXIMAL CONNECTOR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10856696 ↗
• MalfunctionNov 17, 2020Device Misassembled During Manufacturing /Shipping; Device Misassembled During Manufacturing /Shipping

  IT WAS REPORTED THAT IT SEEMED THAT THE VENTRICULAR CONNECTION SITE WAS MUCH SHORTER THAN IT WAS SUPPOSED TO BE. THE FACILITY WAS CURRENTLY CEASING ALL USE OF THE VALVES. ADDITIONAL INFORMATION RECEIVED REPORTED THAT JUST BY LOOKING AT THE VALVE IN THE STERILE PACKAGING, THERE WAS A DISTINCT DIFFERENCE BETWEEN THE TWO CONNECTORS. THE DISTAL CONNECTOR WAS MUCH LONGER THAN THE PROXIMAL CONNECTOR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10856692 ↗
• MalfunctionNov 17, 2020Device Misassembled During Manufacturing /Shipping; Device Misassembled During Manufacturing /Shipping

  IT WAS REPORTED THAT IT SEEMED THAT THE VENTRICULAR CONNECTION SITE WAS MUCH SHORTER THAN IT WAS SUPPOSED TO BE. THE FACILITY WAS CURRENTLY CEASING ALL USE OF THE VALVES. ADDITIONAL INFORMATION RECEIVED REPORTED THAT JUST BY LOOKING AT THE VALVE IN THE STERILE PACKAGING, THERE WAS A DISTINCT DIFFERENCE BETWEEN THE TWO CONNECTORS. THE DISTAL CONNECTOR WAS MUCH LONGER THAN THE PROXIMAL CONNECTOR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10856653 ↗
• MalfunctionNov 17, 2020Device Misassembled During Manufacturing /Shipping; Device Misassembled During Manufacturing /Shipping

  IT WAS REPORTED THAT IT SEEMED THAT THE VENTRICULAR CONNECTION SITE WAS MUCH SHORTER THAN IT WAS SUPPOSED TO BE. THE FACILITY WAS CURRENTLY CEASING ALL USE OF THE VALVES. ADDITIONAL INFORMATION RECEIVED REPORTED THAT JUST BY LOOKING AT THE VALVE IN THE STERILE PACKAGING, THERE WAS A DISTINCT DIFFERENCE BETWEEN THE TWO CONNECTORS. THE DISTAL CONNECTOR WAS MUCH LONGER THAN THE PROXIMAL CONNECTOR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10856623 ↗
• MalfunctionNov 17, 2020Device Misassembled During Manufacturing /Shipping; Device Misassembled During Manufacturing /Shipping

  IT WAS REPORTED THAT IT SEEMED THAT THE VENTRICULAR CONNECTION SITE WAS MUCH SHORTER THAN IT WAS SUPPOSED TO BE. THE FACILITY WAS CURRENTLY CEASING ALL USE OF THE VALVES. ADDITIONAL INFORMATION RECEIVED REPORTED THAT JUST BY LOOKING AT THE VALVE IN THE STERILE PACKAGING, THERE WAS A DISTINCT DIFFERENCE BETWEEN THE TWO CONNECTORS. THE DISTAL CONNECTOR WAS MUCH LONGER THAN THE PROXIMAL CONNECTOR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10856545 ↗
• MalfunctionNov 17, 2020Device Misassembled During Manufacturing /Shipping; Device Misassembled During Manufacturing /Shipping

  IT WAS REPORTED THAT IT SEEMED THAT THE VENTRICULAR CONNECTION SITE WAS MUCH SHORTER THAN IT WAS SUPPOSED TO BE. THE FACILITY WAS CURRENTLY CEASING ALL USE OF THE VALVES. ADDITIONAL INFORMATION RECEIVED REPORTED THAT JUST BY LOOKING AT THE VALVE IN THE STERILE PACKAGING, THERE WAS A DISTINCT DIFFERENCE BETWEEN THE TWO CONNECTORS. THE DISTAL CONNECTOR WAS MUCH LONGER THAN THE PROXIMAL CONNECTOR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10856539 ↗
• MalfunctionNov 17, 2020Device Misassembled During Manufacturing /Shipping; Device Misassembled During Manufacturing /Shipping

  IT WAS REPORTED THAT IT SEEMED THAT THE VENTRICULAR CONNECTION SITE WAS MUCH SHORTER THAN IT WAS SUPPOSED TO BE. THE FACILITY WAS CURRENTLY CEASING ALL USE OF THE VALVES. ADDITIONAL INFORMATION RECEIVED REPORTED THAT JUST BY LOOKING AT THE VALVE IN THE STERILE PACKAGING, THERE WAS A DISTINCT DIFFERENCE BETWEEN THE TWO CONNECTORS. THE DISTAL CONNECTOR WAS MUCH LONGER THAN THE PROXIMAL CONNECTOR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10856525 ↗
• MalfunctionNov 17, 2020Device Misassembled During Manufacturing /Shipping; Device Misassembled During Manufacturing /Shipping

  IT WAS REPORTED THAT IT SEEMED THAT THE VENTRICULAR CONNECTION SITE WAS MUCH SHORTER THAN IT WAS SUPPOSED TO BE. THE FACILITY WAS CURRENTLY CEASING ALL USE OF THE VALVES. ADDITIONAL INFORMATION RECEIVED REPORTED THAT JUST BY LOOKING AT THE VALVE IN THE STERILE PACKAGING, THERE WAS A DISTINCT DIFFERENCE BETWEEN THE TWO CONNECTORS. THE DISTAL CONNECTOR WAS MUCH LONGER THAN THE PROXIMAL CONNECTOR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10856506 ↗
• MalfunctionNov 17, 2020Device Misassembled During Manufacturing /Shipping; Device Misassembled During Manufacturing /Shipping

  IT WAS REPORTED THAT IT SEEMED THAT THE VENTRICULAR CONNECTION SITE WAS MUCH SHORTER THAN IT WAS SUPPOSED TO BE. THE FACILITY WAS CURRENTLY CEASING ALL USE OF THE VALVES. ADDITIONAL INFORMATION RECEIVED REPORTED THAT JUST BY LOOKING AT THE VALVE IN THE STERILE PACKAGING, THERE WAS A DISTINCT DIFFERENCE BETWEEN THE TWO CONNECTORS. THE DISTAL CONNECTOR WAS MUCH LONGER THAN THE PROXIMAL CONNECTOR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10856486 ↗
• MalfunctionNov 17, 2020Device Misassembled During Manufacturing /Shipping; Device Misassembled During Manufacturing /Shipping

  IT WAS REPORTED THAT IT SEEMED THAT THE VENTRICULAR CONNECTION SITE WAS MUCH SHORTER THAN IT WAS SUPPOSED TO BE. THE FACILITY WAS CURRENTLY CEASING ALL USE OF THE VALVES. ADDITIONAL INFORMATION RECEIVED REPORTED THAT JUST BY LOOKING AT THE VALVE IN THE STERILE PACKAGING, THERE WAS A DISTINCT DIFFERENCE BETWEEN THE TWO CONNECTORS. THE DISTAL CONNECTOR WAS MUCH LONGER THAN THE PROXIMAL CONNECTOR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10856352 ↗
• MalfunctionNov 17, 2020Device Misassembled During Manufacturing /Shipping; Device Misassembled During Manufacturing /Shipping

  IT WAS REPORTED THAT IT SEEMED THAT THE VENTRICULAR CONNECTION SITE WAS MUCH SHORTER THAN IT WAS SUPPOSED TO BE. THE FACILITY WAS CURRENTLY CEASING ALL USE OF THE VALVES. ADDITIONAL INFORMATION RECEIVED REPORTED THAT JUST BY LOOKING AT THE VALVE IN THE STERILE PACKAGING, THERE WAS A DISTINCT DIFFERENCE BETWEEN THE TWO CONNECTORS. THE DISTAL CONNECTOR WAS MUCH LONGER THAN THE PROXIMAL CONNECTOR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10856345 ↗
• MalfunctionNov 17, 2020Device Misassembled During Manufacturing /Shipping; Device Misassembled During Manufacturing /Shipping

  IT WAS REPORTED THAT IT SEEMED THAT THE VENTRICULAR CONNECTION SITE WAS MUCH SHORTER THAN IT WAS SUPPOSED TO BE. THE FACILITY WAS CURRENTLY CEASING ALL USE OF THE VALVES. ADDITIONAL INFORMATION RECEIVED REPORTED THAT JUST BY LOOKING AT THE VALVE IN THE STERILE PACKAGING, THERE WAS A DISTINCT DIFFERENCE BETWEEN THE TWO CONNECTORS. THE DISTAL CONNECTOR WAS MUCH LONGER THAN THE PROXIMAL CONNECTOR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10856309 ↗
• MalfunctionNov 17, 2020Device Misassembled During Manufacturing /Shipping; Device Misassembled During Manufacturing /Shipping

  IT WAS REPORTED THAT IT SEEMED THAT THE VENTRICULAR CONNECTION SITE WAS MUCH SHORTER THAN IT WAS SUPPOSED TO BE. THE FACILITY WAS CURRENTLY CEASING ALL USE OF THE VALVES. ADDITIONAL INFORMATION RECEIVED REPORTED THAT JUST BY LOOKING AT THE VALVE IN THE STERILE PACKAGING, THERE WAS A DISTINCT DIFFERENCE BETWEEN THE TWO CONNECTORS. THE DISTAL CONNECTOR WAS MUCH LONGER THAN THE PROXIMAL CONNECTOR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10856307 ↗
• MalfunctionNov 17, 2020Device Misassembled During Manufacturing /Shipping; Device Misassembled During Manufacturing /Shipping

  IT WAS REPORTED THAT IT SEEMED THAT THE VENTRICULAR CONNECTION SITE WAS MUCH SHORTER THAN IT WAS SUPPOSED TO BE. THE FACILITY WAS CURRENTLY CEASING ALL USE OF THE VALVES. ADDITIONAL INFORMATION RECEIVED REPORTED THAT JUST BY LOOKING AT THE VALVE IN THE STERILE PACKAGING, THERE WAS A DISTINCT DIFFERENCE BETWEEN THE TWO CONNECTORS. THE DISTAL CONNECTOR WAS MUCH LONGER THAN THE PROXIMAL CONNECTOR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10855611 ↗
• MalfunctionSep 14, 2020Break; Break

  IT WAS REPORTED THAT THE VALVE HAD A DAMAGED DISTAL CATHETER CONNECTOR.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Known Impact Or Consequence To Patient

  MAUDE report 10530957 ↗

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-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-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-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