Trifecta Heart Valve
Brand(s)
Summary
Contact the manufacturer if you require additional information.
Affected products
Affected products |
Lot or serial number |
Model or catalog number |
|---|---|---|
Trifecta Heart Valve |
More than 10 numbers, contact manufacturer. |
TF-23A |
Trifecta Valve With Glide Technology |
More than 10 numbers, contact manufacturer. |
TFGT-23A |
Problème
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
Additional information
Details
St. Jude Medical
177 County Road B East, St. Paul, Minnesota, United States, 55117