Abbott Proclaim 7 Implantable Pulse Generator — Class II medical device recall Z-2363-2024
Ongoing recall by Abbott Medical, reported 2024-07-24, distributed nationwide. The duration between the implantable pulse generator reaching the elective replacement indicator threshold and
| Recall number | Z-2363-2024 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Abbott Medical, Plano, TX, United States |
| Recall initiated | 2024-05-16 |
| Classified | 2024-07-16 |
| Reported by FDA | 2024-07-24 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AR, AT, AU, BE, BR, CA, CH, CL, CN, CO, CR, CY, CZ, DE, DK, EE, ES, FI, FR, GB, GR, HU, IE, IL, IT, JP, KR, KW, LT, LU, MX, NL, NO, NZ, PL, PT, SA, SE, SG, SI, TR, TW, ZA |
| Quantity | 457 unity |
| Reason classes | labeling |
| UPC / GTIN / UDI-DI | 05415067023254 |
| Model numbers | 3667 |
Product
Abbott Proclaim 7 Implantable Pulse Generator, REF 3667, Sterile EO, Rx Only
Reason for recall
The duration between the implantable pulse generator reaching the elective replacement indicator threshold and end of service may be shorter than indicated in product labeling.
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-2363-2024. 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.