Medtronic SynchroMed EL Programmable pumps — Class I medical device recall Z-1571-2013
Terminated recall by Medtronic Neuromodulation, reported 2013-07-03, distributed nationwide. Medtronic is providing Healthcare Professionals with important safety information and patient management recom
| Recall number | Z-1571-2013 |
|---|---|
| Product type | Medical device |
| Classification | Class I |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Medtronic Neuromodulation, Minneapolis, MN, United States |
| Recall initiated | 2013-06-03 |
| Classified | 2013-06-25 |
| Reported by FDA | 2013-07-03 |
| Terminated | 2015-05-14 |
| Distributed | Nationwide (US) |
| Quantity | 261,109 devices |
| Model numbers | 8626, 8626L, 8627, 8627L |
Product
Medtronic SynchroMed EL Programmable pumps, Models 8626, 8626L, 8627, 8627L, (The SynchroMed EL Pumps are supplied in 10 ml or 18 ml reservoir size.) Sterilized using ethylene oxide. Product Usage: The pump is part of an infusion system that stores and delivers a prescribed drug to a specific site. The drug is stored in the pump reservoir. Per a programmed prescription, the drug moves from the pump reservoir, through the pump tubing, catheter port, and catheter, to the infusion site. The SynchroMed II Programmable Pump is indicated when patient therapy requires the chronic infusion of the following drugs or fluids: Chronic intraspinal (epidural and intrathecal) infusion of preservative-free morphine sulfate sterile solution in the treatment of chronic intractable pain, Chronic intrathecal infusion of preservative-free ziconotide sterile solution for the management of severe chronic pain, Chronic intrathecal infusion of Lioresal Intrathecal (baclofen Injection ) in the management of serve spasticity, Chronic Intravascular Infusion of Floxuridine (FUDR) or methotrexate for the treatment of primary or metastatic cancer.
Reason for recall
Medtronic is providing Healthcare Professionals with important safety information and patient management recommendations regarding the unintended delivery of drug during the priming bolus function for the SynchroMed implantable infusion pump. The unintended delivery of drug can contribute to patient overdose or underdose symptoms which may be clinically relevant.
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-1571-2013. 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.