Medtronic Preimplantation Test Kit — Class II medical device recall Z-1810-2013
Terminated recall by Medtronic Neurosurgery, reported 2013-07-31, distributed nationwide. Medtronic Neurosurgery is recalling the Medtronic Preimplantation Test Kit because the outer carton had expira
| Recall number | Z-1810-2013 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Medtronic Neurosurgery, Goleta, CA, United States |
| Recall initiated | 2013-06-28 |
| Classified | 2013-07-25 |
| Reported by FDA | 2013-07-31 |
| Terminated | 2013-09-23 |
| Distributed | Nationwide (US) |
| Quantity | 915 units |
| Reason classes | sterility |
| Model numbers | 21047 |
Product
Medtronic Preimplantation Test Kit, Catalog No. 21047. The kit is indicated for use with Medtronic CSF-Flow Control Valves and Delta Valves, when a simple preimplantation test is desired to verify that the valve conforms to labeled product specifications.
Reason for recall
Medtronic Neurosurgery is recalling the Medtronic Preimplantation Test Kit because the outer carton had expiration dates that were incorrect. The date on the outer carton is later than the expiration date for one or more of the individually packaged sterile components in the kit.
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-1810-2013. 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.