Class II — Potential Health Hazard

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

Cyberonics Vagus Nerve Stimulator (VNS) Therapy AspireSR Generator Recalled by Cyberonics, Inc Due to Certain Model 106 Pulse Generators demonstrate delays in...

Date: October 7, 2015
Company: Cyberonics, Inc
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 Cyberonics, Inc directly.

Affected Products

Cyberonics Vagus Nerve Stimulator (VNS) Therapy AspireSR Generator, Model 106

Quantity: 27 units

Why Was This Recalled?

Certain Model 106 Pulse Generators demonstrate delays in sensing during use of the 'Verify Heartbeat Detection' feature and exhibit potential for decreased battery longevity.

Where Was This Sold?

This product was distributed to 17 states: CA, CO, FL, GA, IL, IN, KS, KY, MI, NY, NC, OH, OR, PA, TX, UT, WV

Affected (17 states)Not affected

About Cyberonics, Inc

Cyberonics, Inc has 9 total recalls tracked by RecallDetector.

Related Recalls

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