Medtronic Neurosurgery: Medical Device Recall in 2021 - (Recall #: Z-0871-2021)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2021.

Data Source: FDA.

Product Description:

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.

Product Classification:

Class II

Date Initiated: December 16, 2020

Date Posted: January 27, 2021

Recall Number: Z-0871-2021

Event ID: 87069

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

Status: Ongoing

Product Quantity: 95 units

Code Information:

Lot # 0219927059, 0220149614, 0220393237, 0220601648,0220601649, 0220813029

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.

Voluntary or Mandated:

Voluntary: Firm initiated