FDA Device recall Z-2432-2024
Abbott Infinity 7, Implantable Pulse Generator, REF: 6663, SterileEO, Rx Only
- FDA Device
- Class II
- ongoing
- Published 2024-07-31
On 2024-07-31 the FDA classified a Class II recall of Abbott Infinity 7, Implantable Pulse Generator, REF: 6663, SterileEO, Rx Only by Abbott Medical, citing their is a potential that the implantable pulse generator replacement indicator and end of service date may be shorter than indicated in the product labeling potentially resulting….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2432-2024 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2024-05-22 |
| Published | 2024-07-31 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Abbott Medical |
| Distribution | US |
Product
Abbott Infinity 7, Implantable Pulse Generator, REF: 6663, SterileEO, Rx Only
Reason
Their is a potential that the implantable pulse generator replacement indicator and end of service date may be shorter than indicated in the product labeling potentially resulting in loss of therapy.
Identifiers
| code_info | All Serial numbers/UDI: 05415067020277 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2432-2024%22
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