Abbott sent a customer communication on 2023-02-27 to raise awareness around the potential for early structural valve deterioration (SVD), a known risk associated with these devices, compared to other valves and to provide reminders and considerations with regards to this known risk. There are no new issues regarding safety, efficacy or usefulness of the device, and no changes to the approved labeling. Recall start date: March 17, 2023
RecallTracker