Z-1694-2017Class II

SynchroMed II implantable drug infusion pump, Model 8637-40

Name: Z-1694-2017 SynchroMed II implantable drug infusion pump, Model 8637-40
Creator: Medtronic Neuromodulation
Published: 2017-02-09
License: https://open.fda.gov/license/

Medtronic Neuromodulation / initiated 2017-02-09 / Terminated

FDA source

Medtronic Neuromodulation began a recall of SynchroMed II implantable drug infusion pump, Model 8637-40 on 2017-02-09. FDA classified it as Class II and gives the reason as "Medtronic received a complaint that there was an error code displayed on the programmer when the physician attempted to interrogate an implanted SynchroMed II pump. The error code prevented the physician from updating...". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1694-2017
Classification: Class II
Status: Terminated
Initiated: 2017-02-09
Posted: 2017-03-29
Terminated: 2018-09-04
Recalling firm: Medtronic Neuromodulation
Product: SynchroMed II implantable drug infusion pump, Model 8637-40,
Product code: LKK Pump, Infusion, Implanted, Programmable
Reason for recall: Medtronic received a complaint that there was an error code displayed on the programmer when the physician attempted to interrogate an implanted SynchroMed II pump. The error code prevented the physician from updating the pump; however the pump was providing therapy.
FDA root cause: Under Investigation by firm
Action: A Medtronic representative visited the clinic on 2/9/2017 and corrected the SynchroMed II pump by resetting the pump memory using a SynchroMed Lab Programmer running on a Medtronic laptop with a validated protocol. Consignee was given a Medtronic "Urgent Medical Device Correction" letter dated February 8, 2017. The letter described the Issue and Actions to be taken by the consignee. For questions contact your Medtronic Representative Medtronic or Neuromodulation Technical Services at 1-800-707-0933.
Quantity in commerce: 1
Distribution: IL
Product codes and lots: Serial Number NGV526743H

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1694-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1694-2017	Class II	Terminated	Voluntary: Firm initiated	2017-04-05	2017-03-29

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)