Medtronic InSync III, model 8042, 8042B and 8042U. Implantable pulse generator pacemaker.
FDA Recall Notice
Source: U.S. Food and Drug Administration (FDA) — official FDA notice for recall FDA-Z-0342-2016.
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.
Corrective Action (per FDA)
Source: U.S. Food and Drug Administration (FDA) — official FDA notice for recall FDA-Z-0342-2016.
Recall terminated by FDA.
✅ What you should do
- Stop using the product if you own it.
- Check the model number, lot code, or sell-by date against the recall notice above.
- Contact Medtronic Inc. or the retailer where you bought it for a refund, replacement, or repair.
- For the most current official instructions, visit the FDA recall page.
- If you've been hurt by this product, report the incident to FDA.
Consumer Contact (per FDA)
Source: U.S. Food and Drug Administration (FDA) — official FDA notice for recall FDA-Z-0342-2016.
Medtronic Inc.
About the U.S. Food and Drug Administration
The FDA regulates drugs, medical devices, food, cosmetics, and tobacco. Adverse event reports and recall notices are the main public safety signal.
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If you had a reaction, found contamination, or experienced a labeling problem with this product, report it to the FDA. The agency uses consumer reports to track emerging safety signals and trigger recalls.
Medtronic Inc. Recall FAQ
Medtronic Inc. is the subject of a medical implants safety report: Medtronic InSync III, model 8042, 8042B and 8042U. Implantable pulse generator pacemaker.. The notice was published on November 9, 2015 by the U.S. Food and Drug Administration (FDA). Approximately 96,787 units are potentially affected.