Medtronic Neurosurgery 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. Recall
Hazard assessment based on recall description.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
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.
Brand
Medtronic Neurosurgery
Lot Codes / Batch Numbers
Lot # 0219948893, 0220166870, 0220236215, 0220704352, 0220720015, 0220752505
Products Sold
Lot # 0219948893, 0220166870, 0220236215, 0220704352, 0220720015, 0220752505
Medtronic Neurosurgery is recalling REF 27219-5 X1, Medtronic, Delta Valve, Neonatal, Performance Level 1.5, CE 0344, Sterile EO - Prod due to Neonatal Valves were manufactured with a ventricular catheter connection site shorter than the design specification. The defect can lead to difficulty. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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
Recommended Action
Per FDA guidance
On 12/16/2020, Medtronic sent a "URGENT: MEDICAL DEVICE RECALL" notification to affected customers via FedEx. In addition, to notifying consignees about the recall, the firm ask consignees to take the following actions: 1. Identify, segregate, and quarantine affected valves within your inventory. 2. Contact Medtronic to return affected valves and receive replacement(s). See instructions below. 3. Please complete and return the customer confirmation form, even if you do not have any affected valves. 4. Return the form via email to RS.NavFCA@Medtronic.com or via fax to 651-367-7075 within 30 days of receipt.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026