Class 2 Device Recall Delta" Neonatal Valves

• Date Initiated by Firm: December 16, 2020
• Create Date: January 15, 2021
• Recall Status: Open, Classified
• Recall Number: Z-0871-2021
• Recall Event ID: 87069
• 510(K)Number: K902783
• Product Classification: Shunt, central nervous system and components - Product Code JXG
• Product: 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.
• Code Information: Lot # 0219927059, 0220149614, 0220393237, 0220601648,0220601649, 0220813029
• Recalling Firm/ Manufacturer: Medtronic Neurosurgery; 5290 California Ave; Irvine CA 92617-3073
• For Additional Information Contact: David Young; 508-452-1644
• Manufacturer Reason for Recall: 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
• FDA Determined Cause: Device Design
• Action: 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.
• Quantity in Commerce: 95 units
• 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.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.

• 510(K) Database: 510(K)s with Product Code = JXG