Z-1571-2013 Class I Terminated
FDA device recall Z-1571-2013 was initiated by Medtronic Neuromodulation on Jun 3, 2013 and is designated Class I. 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 recall status is terminated (terminated May 14, 2015). Affected quantity: 261,109 total devices estimated implanted Worldwide.
Recall Details
- Product Type
- Devices
- Report Date
- Jul 3, 2013
- Initiation Date
- Jun 3, 2013
- Termination Date
- May 14, 2015
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 261,109 total devices estimated implanted Worldwide
Product Description
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.
Distribution Pattern
Worldwide Distribution - USA Nationwide
Code Information
all SynchroMed EL pumps
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-1571-2013
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 26, 2026