FDA Device recall Z-1525-2021
Implantable Pulse Generators - Product Usage: used to treat arrhythmias related to bradycardia
- FDA Device
- Class II
- ongoing
- Published 2021-05-12
On 2021-05-12 the FDA classified a Class II recall of Implantable Pulse Generators - Product Usage: used to treat arrhythmias related to bradycardia by Medtronic Cardiac Rhythm And Heart Failure Crhf, citing A longevity estimation error may occur in the early years of device life when a unipolar pacing vector is programmed in the right atrial (RA) lead and/or the right ventricular (RV….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1525-2021 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2021-04-06 |
| Published | 2021-05-12 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Medtronic Cardiac Rhythm And Heart Failure Crhf |
| Distribution | n/a |
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 SureScan, Azure XT SR MRI SureScan, Azure S SR MRI SureScan. 2. Astra family: Astra XT DR MRI SureScan, Astra XT SR MRI SureScan.
Reason
A longevity estimation error may occur in the early years of device life when a unipolar pacing vector is programmed in the right atrial (RA) lead and/or the right ventricular (RV) lead. No other device features or therapies are impacted.
Identifiers
| code_info | all codes |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1525-2021%22
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