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.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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
- Affected units
- 96,787
Distribution
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