Medtronic Recalls Implantable Pulse Generators Due to Longevity Estimation Error
Medtronic is recalling implantable pulse generators because a longevity estimation error may occur in early device life when specific pacing vectors are programmed.
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 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, but the source text explicitly states that no other device features or therapies are impacted, and the defect is limited to a longevity estimation error rather than a direct safety hazard like failure to pace or shock. This aligns with the rubric for moderate severity involving low-risk issues or voluntary precautionary measures where no immediate harm is reported.
Plain-English summary
Medtronic Inc. is recalling specific models of implantable pulse generators, including the Azure and Astra families, due to a potential longevity estimation error. The issue affects devices used to treat arrhythmias related to bradycardia and heart failure. The error may occur in the early years of the device's life when a unipolar pacing vector is programmed in the right atrial and/or right ventricular lead. No other device features or therapies are impacted by this defect.
Approximately 575,815 units were distributed worldwide. The recall applies to all codes for the affected product lines. Medtronic has identified that the longevity estimation function may provide inaccurate information under these specific programming conditions, though the device's core therapeutic functions remain unaffected.
Patients with these implanted devices should contact their healthcare provider or Medtronic for guidance on monitoring the device's longevity and any necessary follow-up care. The company is working to address the estimation error to ensure accurate device management.
The recalled product
- Product
- Implantable Pulse Generators - Product Usage: used to treat arrhythmias related to bradycardia. Additionally, CRT-P devices can also provide cardiac resynchronization therapy (CRT) in treatment of heart failure. 1. Azure family: Azure XT DR MRI SureScan", Azure S DR MRI…
- Hazard
- Affected units
- 575,815
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- all codes
Distribution
Distribution scope not specified by the agency.
Part of a larger recall action
This product is one of 4 recalled by Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 4 products in this recall →Related recalls
Same manufacturer · Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
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