REF 27219-2 X1, Medtronic, Delta Valve, Neonatal, Performance Level 2.0, 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.
Enforcement
- Recall Number
- Z-0872-2021
- Event ID
- 87069
- Classification
- Class II
- Status
- Ongoing
- Product Type
- Devices
- Firm
- Medtronic Neurosurgery
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- January 27, 2021
- Initiation Date
- December 16, 2020
- Classification Date
- January 15, 2021
- Address
- 5290 California Ave, N/A, Irvine, CA, 92617-3073, United States
Description
REF 27219-2 X1, Medtronic, Delta Valve, Neonatal, Performance Level 2.0, 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.
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
Lot # 0219281777
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.
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