Recall Z-0561-2021— Medtronic Heart Valves Division
Class II · Terminated
Class II FDA medical device recall by Medtronic Heart Valves Division, initiated 2020-10-23, terminated 2022-11-22. FDA's recall record names no specific 510(k) clearance for this event. Product: Evolut (TM) PRO+ System. With the following model numbers: a. EVPROPLUS-23US, Labeled as VLV EVPROPLUS-23US COMM JPN, VLV EVPROPLUS-23 COMM US; b. EVPROPLUS-26US, Labeled as VLV EVPROPLUS-26US COMM JPN, VLV EVPROPLUS-26 COMM US; c. EVPROPLUS-29US, Labeled as VLV EVPROPLUS-29US COMM JPN, VLV EVPROPLUS-29 COMM US; d. EVPROPLUS-34US, Labeled as VLV EVPROPLUS-34 COMM US, VLV EVPROPLUS-34 COMM US SA.. Reason: Potential for Transcatheter Aortic Valve (TAV) leaflet damage when performing a post-implant balloon dilatation (PID)..
- Recalling firm
- Medtronic Heart Valves Division
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2020-10-23
- Terminated
- 2022-11-22
- Firm location
- Santa Ana, CA, United States
Product description
Evolut (TM) PRO+ System. With the following model numbers: a. EVPROPLUS-23US, Labeled as VLV EVPROPLUS-23US COMM JPN, VLV EVPROPLUS-23 COMM US; b. EVPROPLUS-26US, Labeled as VLV EVPROPLUS-26US COMM JPN, VLV EVPROPLUS-26 COMM US; c. EVPROPLUS-29US, Labeled as VLV EVPROPLUS-29US COMM JPN, VLV EVPROPLUS-29 COMM US; d. EVPROPLUS-34US, Labeled as VLV EVPROPLUS-34 COMM US, VLV EVPROPLUS-34 COMM US SA.
Reason for recall
Potential for Transcatheter Aortic Valve (TAV) leaflet damage when performing a post-implant balloon dilatation (PID).
Data sourced from openFDA. This site is unofficial and independent of the FDA.