Recall Z-2362-2024— Abbott Medical
Class II · Ongoing
Class II FDA medical device recall by Abbott Medical, initiated 2024-05-16. FDA's recall record names no specific 510(k) clearance for this event. 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..
- Recalling firm
- Abbott Medical
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2024-05-16
- Firm location
- Plano, TX, United States
Product description
Abbott Proclaim 5 Implantable Pulse Generator, REF 3665, 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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.