REF 27219-2 X1 — Class II medical device recall Z-0872-2021
Ongoing recall by Medtronic Neurosurgery, reported 2021-01-27, distributed nationwide. Neonatal Valves were manufactured with a ventricular catheter connection site shorter than the design specific
| Recall number | Z-0872-2021 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Medtronic Neurosurgery, Irvine, CA, United States |
| Recall initiated | 2020-12-16 |
| Classified | 2021-01-15 |
| Reported by FDA | 2021-01-27 |
| Distributed | Nationwide (US) |
| Countries outside the US | AU, BR, CY, ES, GB, IE, MX, QA, RO, RS, ZA |
| Reason classes | device malfunction |
| Lot numbers | 0219281777 |
| Model numbers | 27219-2 |
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
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0872-2021. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.