Z-0788-2017 Class I Terminated
FDA device recall Z-0788-2017 was initiated by Medtronic Neuromodulation on Oct 3, 2016 and is designated Class I. Reason for recall: 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… The recall status is terminated (terminated Jun 2, 2022). Affected quantity: 22,298 software cards.
Recall Details
- Product Type
- Devices
- Report Date
- Mar 8, 2017
- Initiation Date
- Oct 3, 2016
- Termination Date
- Jun 2, 2022
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 22,298 software cards
Product Description
Medtronic SynchroMed II Implantable Drug Infusion System. This system includes: Model 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 Usage: 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 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.
Distribution Pattern
Worldwide Distribution - (US Nationwide) Internationally to Germany, Greece, Australia, United Kingdom, Switzerland, Italy, Norway, France, Canada, and Malta.
Code Information
software application cards with versions other than AAU01
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-0788-2017
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 26, 2026