Z-0788-2017Class I

Medtronic SynchroMed II Implantable Drug Infusion System. This system includes: Model 8870 Software...

Name: Z-0788-2017 Medtronic SynchroMed II Implantable Drug Infusion System. This system includes: Model 8870 Software...
Creator: Medtronic Neuromodulation
Published: 2016-10-03
License: https://open.fda.gov/license/

Medtronic Neuromodulation / initiated 2016-10-03 / Terminated / root cause: labeling and UDI

FDA source

Medtronic Neuromodulation began a recall of Medtronic SynchroMed II Implantable Drug Infusion System. This system includes: Model 8870 Software Application Card, Model 8840 N'Vision Clinician Programmer... on 2016-10-03. FDA classified it as Class I and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-0788-2017
Classification: Class I
Status: Terminated
Initiated: 2016-10-03
Posted: 2016-12-19
Terminated: 2022-06-02
Recalling firm: Medtronic Neuromodulation
Product: 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
Product code: LKK Pump, Infusion, Implanted, Programmable
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.
Root cause tag: labeling and UDI
FDA root cause: Under Investigation by firm
Action: Medtronic Representatives began visiting consignees on 10/3/2016 to replace previous version Model 8870 software application cards, contained within the model 8840 N Vision Clinician Programmer, with the updated version (new version is AAU01). Beginning October 20, 2016, Implanting and Following physicians were sent an Urgent Medical Device Correction letter dated September 2016, . This letter to physicians is informing them of the updated Model 8870 software application card, and changes to SynchroMed infusion system labeling. A response form is requested to be returned to Medtronic. Customers with questions were instructed to contact Medtronic Neuromodulation Technical Services at 1-800-707-0933.
Quantity in commerce: 22,298 software cards
Distribution: Worldwide Distribution - (US Nationwide) Internationally to Germany, Greece, Australia, United Kingdom, Switzerland, Italy, Norway, France, Canada, and Malta.
Product codes and lots: software application cards with versions other than AAU01

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0788-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0788-2017	Class I	Terminated	Voluntary: Firm initiated	2017-03-08	2017-03-01

Product code LKK

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)