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Recall Observatory FDA recall evidence

Device 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.

Z-0873-2021

December 16, 2020

Class II

Product summary

Firm
Medtronic Neurosurgery
Event
Event 87069
Status
Ongoing
Classification
Class II
Quantity
N/A
Official record key
device-enforcement:Z-0873-2021

Official wording

Reason: 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

Code information: Lot # 0219948893, 0220166870, 0220236215, 0220704352, 0220720015, 0220752505

Distribution pattern: 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.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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