Abbott Infinity 5 — Class II medical device recall Z-2429-2024
Ongoing recall by Abbott Medical, reported 2024-07-31, distributed nationwide. Their is a potential that the implantable pulse generator replacement indicator and end of service date may be
| Recall number | Z-2429-2024 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Abbott Medical, Plano, TX, United States |
| Recall initiated | 2024-05-22 |
| Classified | 2024-07-25 |
| Reported by FDA | 2024-07-31 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AR, AT, AU, BE, BR, CA, CO, CY, CZ, DE, DZ, EC, EE, ES, FI, FR, GB, GR, HU, IE, IL, IN, IT, JO, JP, KR, LT, MX, NL, NO, PK, PL, PT, SA, SE, TR, TW, ZA |
| Quantity | 5,900 units |
| Reason classes | labeling |
| UPC / GTIN / UDI-DI | 05415067020246, 05415067030016 |
| Model numbers | 6660 |
Product
Abbott Infinity 5, Implantable Pulse Generator, REF: 6660, SterileEO, Rx Only
Reason for recall
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2429-2024. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.