Delta® 27219-5 (UDI 00643169507395)Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00643169507395), received between Mar 29, 2018 and Mar 19, 2022 — classified as 2 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (2 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. 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 19, 2022Infusion or Flow Problem; Infusion or Flow Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A VALVE. IT WAS REPORTED THAT THE VALVE DID NOT DRAIN LIQUID. THERE WAS A REPORTED DELAY TO THE PROCEDURE OF 1 HOUR. THERE WAS NO REPORTED IMPACT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13826702 ↗
• MalfunctionJan 27, 2020Insufficient Device Problem Information; Appropriate Device Problem Term/Code Not Available; Insufficient Device Problem Information; Appropriate Device Problem Term/Code Not Available

  ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE SHUNT DID NOT DRAIN THE LCR LIQUID AND WAS CHANGED TO A SMALL PROGRAMMABLE SHUNT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9633052 ↗
• InjuryOct 25, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THE IMPLANTED VALVE WAS DEFECTIVE AND WAS EXPLANTED. IT WAS STATED THERE WAS NO ENVIRONMENTAL/EXTERNAL/PATIENT FACTORS THAT MAY HAVE LED OR CONTRIBUTED TO THE ISSUE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9240385 ↗
• MalfunctionMar 19, 2019Loose or Intermittent Connection; Device Dislodged or Dislocated; Loose or Intermittent Connection; Device Dislodged or Dislocated

  IT WAS REPORTED THAT ONE END OF THE VALVE WAS FOUND TO BE WOBBLY INSTEAD OF RIGID. IT WAS NOTED THAT THIS WAS HOW THE PHYSICIAN REMEMBERED THE VALVE TO BE, RIGID ON EACH END SO THEY COULD GET IT ONTO THE CATHETER.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8434924 ↗
• MalfunctionMar 19, 2019Loose or Intermittent Connection; Device Dislodged or Dislocated; Loose or Intermittent Connection; Device Dislodged or Dislocated

  IT WAS REPORTED THAT ONE END OF THE VALVE WAS FOUND TO BE WOBBLY INSTEAD OF RIGID. IT WAS NOTED THAT THIS WAS HOW THE PHYSICIAN REMEMBERED THE VALVE TO BE, RIGID ON EACH END SO THEY COULD GET IT ONTO THE CATHETER.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8434920 ↗
• InjuryMar 29, 2018Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THE PATIENT EXPERIENCED AN ACCUMULATION OF CEREBROSPINAL FLUID (CSF) AND HEAD ENLARGEMENT. THERE WAS NO CSF DRAINAGE WITH THE DEVICE. THE DEVICE WAS REPLACED WITH A NEW ONE AND THE PATIENT¿S STATUS WAS LISTED AS NO INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7382201 ↗

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