Abbott Medical Recall 94796
Description: Abbott Infinity 7, Implantable Pulse Generator, REF: 6663, SterileEO, Rx Only
Abbott Medical Recall 94796 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-2432-2024 |
| Event ID | 94796 |
| Event Description | Abbott Infinity 7, Implantable Pulse Generator, REF: 6663, SterileEO, Rx Only |
| Product Type | Devices |
| Distribution | Worldwide - US Nationwide distribution including in the states of AL, AR, AZ, CA, CO, DC, FL, GA, IL, IN, KY, LA, MA, MD, MI, MN, MO, MT, NC, ND, NE, NH, NJ, NY, OH, OK, OR, PA, PR, SC, TX, UT, VA, WA, WI, WY and the countries of Algeria, Argentina, Australia, Austria, Belgium, Brazil, Canada, Colombia, Cyprus, Czech Republic, Ecuador, Estonia, Finland, France, Germany, Greece, Hungary, India, Ireland, Israel, Italy, Japan, Jordan, Korea, Lithuania, Mexico, Netherlands, Norway, Pakistan, Poland, Portugal, Russian Federation, Saudi Arabia, South Africa, Spain, Sweden, Taiwan, Turkey, United Arab Emirates, United Kingdom. |
| Quantity | 1198 units |
| Recall 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. |
| Device Classification | 20240731 |
| Device Code Info | All Serial numbers/UDI: 05415067020277 |
| Center Classification Date | 20240725 |
| Recall Initiation Date | 20240522 |
| Recalling Firm | Abbott Medical |
| Initial Notification | Letter |
| Similar To |