Recall Z-2042-2021— Medtronic Heart Valves Division
Class II · Ongoing
Class II FDA medical device recall by Medtronic Heart Valves Division, initiated 2021-06-11. FDA's recall record names no specific 510(k) clearance for this event. Product: CoreValve Evolut PRO Delivery Catheter System, REF: ENVPRO-14; ENVPRO-16;. Reason: Due to reports of actuator separation for various delivery catheter systems. Affected products were manufactured before July 11, 2020..
- Recalling firm
- Medtronic Heart Valves Division
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2021-06-11
- Firm location
- Santa Ana, CA, United States
Product description
CoreValve Evolut PRO Delivery Catheter System, REF: ENVPRO-14; ENVPRO-16;
Reason for recall
Due to reports of actuator separation for various delivery catheter systems. Affected products were manufactured before July 11, 2020.
Data sourced from openFDA. This site is unofficial and independent of the FDA.