FDA Device recall Z-0496-2013
SynchroMed EL, models 8626-10, 8626L-10, 8626-18, 8626L-18, 8627-10, 8627L-10, 8627-18, 8627L-18. implantable infusion pump
- FDA Device
- Class I
- terminated
- Published 2012-12-19
On 2012-12-19 the FDA classified a Class I recall of SynchroMed EL, models 8626-10, 8626L-10, 8626-18, 8626L-18, 8627-10, 8627L-10, 8627-18, 8627L-18. implantable infusion pump by Medtronic Neuromodulation, citing medtronic notified Healthcare Professionals of the impact of unapproved drugs on the performance of the SynchroMed infusion pump system. Use of unapproved drugs with SynchroMed pu….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0496-2013 |
| Classification | Class I |
| Status | terminated |
| Initiated | 2012-11-09 |
| Published | 2012-12-19 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Medtronic Neuromodulation |
| Distribution | US |
Product
SynchroMed EL, models 8626-10, 8626L-10, 8626-18, 8626L-18, 8627-10, 8627L-10, 8627-18, 8627L-18. implantable infusion pump. The pump is part of an implanted infusion system that consists of a SynchroMed EL pump and a catheter. The SynchroMed EL Infusion System is indicated for use when patient therapy requires the chronic infusion of drugs or fluids. The SynchroMed EL Infusion System with a 10 mL reservoir volume is indicated for use in the smaller patient who has insufficient body mass to support the larger SynchroMed EL pump or in patients who choose a smaller, lower profile pump when presented with the choice, when patient therapy requires the chronic infusion of drugs or fluids referred to in this manual.
Reason
Medtronic notified Healthcare Professionals of the impact of unapproved drugs on the performance of the SynchroMed infusion pump system. Use of unapproved drugs with SynchroMed pumps can result in an increased risk of permanent motor stall and cessation of drug infusion. UPDATE 2/1/2016: Medtronic received approval to incorporate enhancements to the SynchroMed II pump which decreases the potential for internal electrical shorting and motor corrosion, and is retrieving any unused pumps.
Identifiers
| code_info | All SynchroMed EL and SynchroMed II pumps |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
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Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0496-2013%22
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