Medtronic CoreValve LLC

FDA Regulatory Profile

Medtronic CoreValve LLC appears in FDA public data with 2 recalls, 0 510(k) clearances, 2 FDA inspections, and 0 compliance actions on record. Its most recent recall (Z-1449-2020, Class II) was initiated on January 14, 2020.

Summary

Total Recalls
2
510(k) Clearances
0
Inspections
2
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-1449-2020Class IIMedtronic Simulus 750 Flexible Ring/Band Accessory Kit - Product Usage: Used to size a patient's mitJanuary 14, 2020
Z-1450-2020Class IIMedtronic Simulus 850 Semi Rigid Ring/Band Accessory Kit Used to size a patient's mitral or tricJanuary 14, 2020