Medtronic recalls neonatal Delta Valve shunt components due to potential disconnection causing shunt malfunction. Affected units include specific lot numbers for neonatal CSF flow control systems.
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 that may disconnect from the catheter, risking shunt malfunction. This could affect newborns with brain fluid management systems.
The valve's catheter connection site is shorter than designed, which can cause it to become loose. If disconnected, the shunt may not function properly, leading to fluid buildup or other complications in newborns.
Newborns using Medtronic Delta Valve shunt systems for brain fluid management are most at risk. Parents and caregivers of infants with these shunts should check if their device is affected.
Check for the lot numbers: 0219927059, 0220149614, 0220393237, 0220601648, 0220601649, or 0220813029. These are specific production batches of the neonatal Delta Valve shunt components.
Look for the lot numbers listed: 0219927059, 0220149614, 0220393237, 0220601648, 0220601649, or 0220813029.
The valve's catheter connection site is shorter than designed, which can cause it to become loose and disconnect from the catheter, potentially leading to shunt malfunction.
Check the lot number on your device; affected units include specific batches: 0219927059, 0220149614, 0220393237, 0220601648, 0220601649, or 0220813029.
The recall does not require immediate discontinuation; affected units should be checked and potentially replaced as per the manufacturer's guidance.
We’ve drafted a message you can send Medtronic to request your refund or repair — edit it as you like.
Subject: Recall Z-0871-2021 — Medtronic Medtronic Hello, I own a Medtronic that is covered by recall Z-0871-2021 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.
