Recall Z-2431-2024— Abbott Medical
Class II · Ongoing
Class II FDA medical device recall by Abbott Medical, initiated 2024-05-22. FDA's recall record names no specific 510(k) clearance for this event. Product: Abbott Infinity 7, Implantable Pulse Generator, REF: 6662, SterileEO, Rx Only. Reason: 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..
- Recalling firm
- Abbott Medical
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2024-05-22
- Firm location
- Plano, TX, United States
Product description
Abbott Infinity 7, Implantable Pulse Generator, REF: 6662, 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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.