Z-1570-2013 Class I Terminated
FDA device recall Z-1570-2013 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 II, Model 8637, (The SynchroMed II Pump is supplied in 20 ml or 40 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 implantable components of the SynchroMed II infusion system include the pump, catheter, and catheter accessories. 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 II pumps
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-1570-2013
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 26, 2026