The Recall Desk
ModerateFDA (Devices)·Z-1694-2017·Announced 2017-04-05

Medtronic Recalls Single SynchroMed II Implantable Drug Infusion Pump

Medtronic is recalling one SynchroMed II implantable drug infusion pump in Illinois due to a programmer error code that prevented updates.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II, and the source text describes a functional error that prevented updates but did not result in reported injury or death, fitting the criteria for a moderate severity precautionary recall.

Plain-English summary

Medtronic Neuromodulation is recalling one unit of the SynchroMed II implantable drug infusion pump, Model 8637-40, with serial number NGV526743H. The device was distributed in Illinois.

The recall was initiated after Medtronic received a complaint that an error code appeared on the programmer when a physician attempted to interrogate the implanted pump. This error code prevented the physician from updating the pump, although the pump continued to provide therapy.

Patients with this specific device should contact their physician or Medtronic for further instructions regarding the recall.

The recalled product

Product
SynchroMed II implantable drug infusion pump, Model 8637-40,
Manufacturer
Medtronic Neuromodulation
Category
Medical Device — Implantable Drug Infusion Pump
Hazard
Affected units
1

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

  • Serial Number NGV526743H

Distribution

Distributed in 1 state:

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