Z-1570-2013Class I

Medtronic SynchroMed II, Model 8637, (The SynchroMed II Pump is supplied in 20 ml or 40 ml reservoir size.)...

Name: Z-1570-2013 Medtronic SynchroMed II, Model 8637, (The SynchroMed II Pump is supplied in 20 ml or 40 ml reservoir size.)...
Creator: Medtronic Neuromodulation
Published: 2013-06-03
License: https://open.fda.gov/license/

Medtronic Neuromodulation / initiated 2013-06-03 / Terminated / root cause: design

FDA source

Medtronic Neuromodulation began a recall of 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... on 2013-06-03. FDA classified it as Class I and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-1570-2013
Classification: Class I
Status: Terminated
Initiated: 2013-06-03
Posted: 2013-06-25
Terminated: 2015-05-14
Recalling firm: Medtronic Neuromodulation
Product: 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.
Product code: LKK Pump, Infusion, Implanted, Programmable
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.
Root cause tag: design
FDA root cause: Device Design
Action: Medtronic sent an Urgent Medical Device Correction letter dated May 2013, to all affected customers. The letter described the background and nature of the issue and provided recommendations for patient management and monitoring after initiation of Intrathecal Therapy. The letter directed customers to continue to use the priming bolus precedure; to monitor all patients following start or restart of intrathecal therapy; consider priming the pump prior to implant; and educate caregivers and family members to recognize the signs and sypmtoms associated with intrathecal drug therapy complications. For questions contact your local Medtronic field representative or Medtronic Neuromodulation Technical Services at 1-800-707-0933.
Quantity in commerce: 261,109 total devices estimated implanted Worldwide
Distribution: Worldwide Distribution - USA Nationwide
Product codes and lots: all SynchroMed II pumps

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1570-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1570-2013	Class I	Terminated	Voluntary: Firm initiated	2013-07-03	2013-06-25
Z-1571-2013	Class I	Terminated	Voluntary: Firm initiated	2013-07-03	2013-06-25

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)