The Recall Desk
HighFDA (Devices)·Z-0342-2016·Announced 2015-12-09

Medtronic InSync III Pacemaker Recall for Battery Impedance Issue

Medtronic is recalling InSync III pacemakers due to unexpected high battery impedance affecting long-term performance.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall is classified as FDA Class II. The hazard involves a medical device defect (battery impedance) that poses a risk of harm to patients, but the source text does not report any specific injuries, hospitalizations, or deaths, placing it in the High severity category per the rubric.

Plain-English summary

Medtronic Inc. is recalling the InSync III implantable pulse generator pacemaker, including models 8042, 8042B, and 8042U. The recall involves 96,787 units that were distributed worldwide, including the United States, Puerto Rico, and numerous international markets.

The recall is being conducted because Medtronic confirmed an issue related to long-term battery performance. The root cause of the defect is identified as unexpected high battery impedance.

Patients with these specific devices should contact their healthcare provider or Medtronic for further instructions regarding the recall and potential replacement or monitoring.

The recalled product

Product
Medtronic InSync III, model 8042, 8042B and 8042U. Implantable pulse generator pacemaker.
Manufacturer
Medtronic Inc.
Category
Medical Device — Pacemaker
Hazard
Affected units
96,787

Distribution

Distributed nationwide across the United States.

The notice also names 2 states specifically:

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