The Recall Desk
ModerateFDA (Devices)·Z-0700-2017·Announced 2016-12-14

Medtronic Recalls Model 37751 Recharger for Spinal Cord Stimulation

Medtronic is recalling Model 37751 Rechargers used for spinal cord stimulation because they may become unresponsive with a blank display and beeping sound.

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 hazard involves a device malfunction that prevents charging but does not report immediate physical injury or death, fitting the criteria for a moderate severity voluntary precautionary recall.

Plain-English summary

Medtronic Neuromodulation is recalling the Model 37751 Recharger, a hand-held device used to charge the battery in a patient's neurostimulator. This recharger is part of the Models 37754 and 97754 Charging Systems used for spinal cord stimulation.

The recall was initiated after Medtronic identified an increased number of customer complaints regarding rechargers entering an unresponsive error state. In this state, the device is non-functional, displays a blank screen, and emits a beep every five seconds. Medtronic determined that rechargers manufactured starting in November 2014, identified by serial numbers beginning with NKA4 or NKU4, are more susceptible to this issue.

The recall affects 42,887 units distributed worldwide, including the United States, Canada, and other countries. Patients and healthcare providers should check the serial numbers on their rechargers to determine if they are affected. If a device is affected, users should contact Medtronic for further instructions on replacement or repair.

The recalled product

Product
Model 37751 Recharger Product Usage: The Medtronic 37751 Recharger is a hand-held device used to charge the battery in a patient s neurostimulator. It includes a display to provide information on the charging system. The charging system consists of the Model 37751 Recharger,
Affected units
42,887

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 numbers beginning with NKA4 or NKU4

Distribution

Distributed nationwide across the United States.

The notice also names 1 state specifically: