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.
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
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.
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.
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.
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.
Inspect the valve for a shorter ventricular catheter connection site than expected. If disconnected, contact your healthcare provider immediately.
The recall addresses a potential risk of shunt malfunction due to improper valve connection. If your baby uses a Medtronic neonatal shunt system, contact your healthcare provider for guidance.
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.
Contact your healthcare provider immediately if the valve appears disconnected. The manufacturer does not provide a specific remedy for this issue.
We’ve drafted a message you can send Medtronic to request your refund or repair — edit it as you like.
Subject: Recall Z-0872-2021 — Medtronic Medtronic Hello, I own a Medtronic that is covered by recall Z-0872-2021 from Medtronic. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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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.