# FDA recall Z-0872-2021

> **Medtronic Neurosurgery** · Class II · device recall initiated 2020-12-16.

## Product

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.

## 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

## 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.

## Key facts

- **Recall number:** Z-0872-2021
- **Recalling firm:** Medtronic Neurosurgery
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2020-12-16
- **Report date:** 2021-01-27

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Irvine, CA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0872-2021

## Citation

> AI Analytics. FDA recall Z-0872-2021. Retrieved 2026-06-05 from https://api.ai-analytics.org/recall/Z-0872-2021. Source: US FDA. Licensed CC0.

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