FDAFDA · Food and drugs·Recall number Z-1571-2013
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.
Published July 3, 2013 · Recall initiated: June 3, 2013
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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.
What to do
Voluntary: Firm initiated · Visit
Recall details
- Manufacturer
- Medtronic Neuromodulation
- Distributor
- Worldwide Distribution - USA Nationwide
- Lot
- all SynchroMed EL pumps
- Risk classification
- Class I
- Area (FDA)
- device
- Country
- United States
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