Urgent Field Safety Notice For Evoque Tricuspid Valve Replacement System: Edwards Evoque Valve By Edwards Lifesciences LLC
Recall Summary Edwards Lifesciences is issuing an urgent safety notice for the EVOQUE Tricuspid Valve Replacement System used in heart valve surgery. The notice was classified as Class I, indicating a serious issue with the device. The affected products were distributed in Germany and the European Union.
- Recalling firm
- Edwards Lifesciences LLC
- Product
- EVOQUE Tricuspid Valve Replacement System: Edwards EVOQUE Valve
- Reason
- Urgent Field Safety Notice for EVOQUE Tricuspid Valve Replacement System: Edwards EVOQUE Valve by Edwards Lifesciences LLC
- Classification
- Class I
- Category
- medical device recall
- Country
- Germany
- Agency
- BFARM
- Recall date
- 2026-04-09
- Status
- Ongoing
- Distribution
- Germany / EU
Official recall notice from BFARM
Recall details on Nibble Recalls: https://trynibble.app/recalls/41424b26-5205-4b26-8cc8-982961a3affd