FDA Device recall Z-2362-2024
Abbott Proclaim 5 Implantable Pulse Generator, REF 3665, Sterile EO, Rx Only
- FDA Device
- Class II
- ongoing
- Published 2024-07-24
On 2024-07-24 the FDA classified a Class II recall of Abbott Proclaim 5 Implantable Pulse Generator, REF 3665, Sterile EO, Rx Only by Abbott Medical, citing 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.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2362-2024 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2024-05-16 |
| Published | 2024-07-24 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Abbott Medical |
| Distribution | US |
Product
Abbott Proclaim 5 Implantable Pulse Generator, REF 3665, Sterile EO, Rx Only
Reason
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.
Identifiers
| code_info | 05415067023247/ All Serial Numbers |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
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FDA Device · Class II · 2026-06-17 · Abbott Medical - Eterna SCS IPG (Implantable Pulse Generator), Model Number 32400
FDA Device · Class II · 2025-11-19 · Abbott Medical - Liberta RC DBS IPG (Implantable Pulse Generator), Model Number 62400
FDA Device · Class II · 2025-11-19 · Abbott Medical - Aveir DR Leadless Pacemaker (LP) Ventricular Device REF LSP202V UDI-DI code: 05415067040725 REF LSP112V UDI-DI code: 05415067034472 The Ave…
FDA Device · Class II · 2025-04-23 · Abbott Medical - The Merlin PCS 3650 programmer Model 3330 The Merlin PCS programmer model 3650 is a portable, dedicated programming system which operates u…
FDA Device · Class II · 2025-01-01 · Abbott Medical
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2362-2024%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.