Class II — Potential Health Hazard

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

Medtronic InSync III Recalled by Medtronic Inc. Due to Medtronic has confirmed an issue with InSync III...

Date: November 9, 2015
Company: Medtronic 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 Medtronic Inc. directly.

Affected Products

Medtronic InSync III, model 8042, 8042B and 8042U. Implantable pulse generator pacemaker.

Quantity: 96,787

Why Was This Recalled?

Medtronic has confirmed an issue with InSync III CRT-pacemaker devices related to long-term battery performance. The root cause is unexpected high battery impedance.

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About Medtronic Inc.

Medtronic Inc. has 85 total recalls tracked by RecallDetector.

Related Recalls

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