REF 27219-5 X1, Medtronic, Delta Valve, Neonatal, Performance Level 1.5, CE 0344, Sterile EO - P...
FDA Recall #Z-0873-2021 — Class II — December 16, 2020
Product Description
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.
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
Recalling Firm
Medtronic Neurosurgery — Irvine, CA
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Devices
Product Quantity
N/A
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.
Code Information
Lot # 0219948893, 0220166870, 0220236215, 0220704352, 0220720015, 0220752505
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated