FDA Device recall Z-2360-2024
Abbott Proclaim XR 7 Implantable Pulse Generator, REF 3662, 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 XR 7 Implantable Pulse Generator, REF 3662, 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-2360-2024 |
| 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 XR 7 Implantable Pulse Generator, REF 3662, 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 | UDI:05415067031426/ 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.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2360-2024%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.