Reported Mar 8, 2017 · Terminated
Medtronic SynchroMed II Implantable Drug Infusion System. This system includes: Model 8870 Software Application Card,…
Medtronic Neuromodulation
High riskUsing this product could cause serious injury, illness or death — stop using it now.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Medtronic Neuromodulation · 7000 Central Ave · Minneapolis, MN · 55421-1241
Is this the product you have?
- Medtronic SynchroMed II Implantable Drug Infusion System
- This system includesModel 8870 Software Application Card, Model 8840 N'Vision Clinician Programmer, and Model 8637 SynchroMed II Implantable Drug Infusion Pump (supplied in 20 ml or 40 ml reservoir size.)
- Product UsageThe SynchroMed II Programmable Pump is indicated when patient therapy requires the chronic infusion
- of the following drugs or fluidsChronic 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
- Lot codes and dates
- software application cards with versions other than AAU01
- Amount recalled
- 22,298 software cards
Where it was sold
- Nationwide
Why it was recalled
Stop using this product now
Medtronic is following up to a May 2013 communication regarding the Priming Bolus function for the SynchroMed Infusion System. Medtronic is updating the Model 8870 software application card (to version AAU01) and the SynchroMed pump labeling to address the priming bolus issue.
Using this product could cause serious injury, illness or death — stop using it now.
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