Refill Kit 8551/856X — Class II medical device recall Z-1568-2014
Terminated recall by Medtronic Neuromodulation, reported 2014-05-14, distributed nationwide. Some refill kits in the affected lots may contain an extension tubing set that is occluded and healthcare prof
| Recall number | Z-1568-2014 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Medtronic Neuromodulation, Minneapolis, MN, United States |
| Recall initiated | 2014-04-04 |
| Classified | 2014-05-08 |
| Reported by FDA | 2014-05-14 |
| Terminated | 2014-11-05 |
| Distributed | Nationwide (US) |
| Countries outside the US | AU, PA, SG, TH |
| Quantity | 13,784 |
| Lot numbers | CS3613, CS3643, CS3663, N440259, N440527, N440582, N440654, N440909, N440978, N441199, N441268, N441806, N441817, N441998, N442081, N442131, N442178, N442513, N442532, N442560, N442588, N442831, N443427 |
| Model numbers | 8551/856X, 8561, 8562, 8564 |
Product
Refill Kit 8551/856X (includes Models 8561, 8562 and 8564) for use with Medtronic Implantable Programmable Infusion Pumps. Product Usage: The Refill Kits are intended for use in refilling Medtronic programmable, implantable infusion pumps with the exception of Medtronic MiniMed infusion pumps.
Reason for recall
Some refill kits in the affected lots may contain an extension tubing set that is occluded and healthcare professionals may be unable to aspirate or fill the SynchroMed pumps. There is no problem with the Lioresal Intrathecal (baclofen injection) contained in the affected drug refill kits. There have been no patient injuries beyond additional needle sticks associated with this issue.
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-1568-2014. 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.