Class II — Potential Health Hazard

Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

SynchroMed II implantable drug infusion pump Recalled by Medtronic Neuromodulation Due to Medtronic received a complaint that there was an...

Date: February 9, 2017
Company: Medtronic Neuromodulation
Status: Terminated
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Medtronic Neuromodulation directly.

Affected Products

SynchroMed II implantable drug infusion pump, Model 8637-40,

Quantity: 1

Why Was This Recalled?

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.

Where Was This Sold?

This product was distributed to 1 state: IL

Affected (1 state)Not affected

About Medtronic Neuromodulation

Medtronic Neuromodulation has 95 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report