Medtronic Neonatal Delta Valve Recall: Risk of Shunt Disconnection
Medtronic recalls neonatal Delta Valve shunt components due to potential shunt malfunction from improper valve connection. Affected units have a shorter ventricular catheter connection site than designed.
Use caution until it’s fixed
Neonatal Valves were manufactured with a ventricular catheter connection site shorter than the design specification. The defect can lead to difficulty in securing the valve to the proximal catheter which could result in disconnection of the ventricular catheter from the valve and shunt malfunction
Contact the company
What happened, in plain English
Medtronic is recalling neonatal Delta Valve shunt components because they may not connect securely to the catheter, risking shunt malfunction. This could affect infants with brain fluid drainage systems. Read more at govinfonow.com/recall/63649-medtronic-neonatal-delta-valve-recall-risk-of-shunt-disconnection.
Source Summary by GovInfoNow · govinfonow.com/recall/63649-medtronic-neonatal-delta-valve-recall-risk-of-shunt-disconnection · Updated August 19, 2026 · FDA enforcement record: FDA #Z-0872-2021
Cite this page
“Medtronic Neonatal Delta Valve Recall: Risk of Shunt Disconnection.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/63649-medtronic-neonatal-delta-valve-recall-risk-of-shunt-disconnection. Based on FDA recall #Z-0872-2021 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0872-2021%22&limit=1).
Why it’s dangerous
The neonatal valve has a shorter ventricular catheter connection site than designed, which can cause the valve to disconnect from the catheter. This disconnection may lead to shunt malfunction, potentially causing brain fluid buildup or other complications.
Who’s affected
Parents and caregivers of infants using Medtronic neonatal shunt systems are most at risk. The affected product is used for brain fluid drainage in newborns.
How to tell if you have this one
Check for the product name 'Delta Valve', model 'X1', and lot number 0219281777. These components are part of neonatal shunt systems for brain fluid drainage.
- Brand
Medtronic- Category
Medical device
All 3 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
- Classification
Class II- Status
Ongoing- Distribution
Worldwide distribution - US Nationwide distribution including in the states of AL, AZ, CA, CO, FL, GA, IL, KS, KY, LA, MA, MI, MO, NV, NM, NY, ND, OH, OK, TN, VA and the countries of Albania, Australia, Brazil, Cyprus, Ireland, Mexico, Qatar, Romania, Russian Federation, Serbia, South Africa, Spain, United Kingdom.
| Recall number | Product, codes & lots | Quantity |
|---|---|---|
| Z-0871-2021 | 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 Control Shunt Systems designed to provide controlled CSF flow from the ventricles of the brain into the peritoneal cavity.; Lot # 0219927059, 0220149614, 0220393237, 0220601648,0220601649, 0220813029 | 95 units |
| Z-0872-2021 | 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 Control Shunt Systems designed to provide controlled CSF flow from the ventricles of the brain into the peritoneal cavity.; Lot # 0219281777 | N/A |
| Z-0873-2021 | 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 Control Shunt Systems designed to provide controlled CSF flow from the ventricles of the brain into the peritoneal cavity.; Lot # 0219948893, 0220166870, 0220236215, 0220704352, 0220720015, 0220752505 | N/A |
What to do — step by step
Check Shunt Connection
Inspect the valve for a shorter ventricular catheter connection site than expected. If disconnected, contact your healthcare provider immediately.
Where it went and when
Where it was distributed
Distributed nationwide and abroad; the notice names 21 states.
FDA distribution: “Worldwide distribution - US Nationwide distribution including in the states of AL, AZ, CA, CO, FL, GA, IL, KS, KY, LA, MA, MI, MO, NV, NM, NY, ND, OH, OK, TN, VA and the countries of Albania, Australia, Brazil, Cyprus, Ireland, Mexico,…” States read from FDA’s own wording; “not listed” means the notice does not name it.
Named in the notice: Alabama, Arizona, California, Colorado, Florida, Georgia, Illinois, Kansas, Kentucky, Louisiana, Massachusetts, Michigan, Missouri, Nevada, New Mexico, New York, North Dakota, Ohio, Oklahoma, Tennessee, Virginia.
Recall timeline
FDA published this recall 42 days after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
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Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #Z-0872-2021 (December 16, 2020) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0872-2021 to see it in context.
- Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.