Recall Z-2264-2015— Medtronic Cardiovascular Surgery-the Heart Valve Division
Class I · Terminated
Class I FDA medical device recall by Medtronic Cardiovascular Surgery-the Heart Valve Division, initiated 2015-07-15, terminated 2016-05-20. FDA's recall record names no specific 510(k) clearance for this event. Product: EnVeo R Loading System, Model No. LS-EnVeoR-23, LS-EnVeoR-2629, LS-EnVeoR-23-C, LS-EnVeoR-2629-C. Cardiovascular valve delivery system for use with the Medtronic CoreValve Evolut R system.. Reason: Medtronic is recalling the EnVeo R Loading Systems because of the presence of particulate..
- Recalling firm
- Medtronic Cardiovascular Surgery-the Heart Valve Division
- Classification
- Class I
- Status
- Terminated
- Initiated
- 2015-07-15
- Terminated
- 2016-05-20
- Firm location
- Santa Ana, CA, United States
Product description
EnVeo R Loading System, Model No. LS-EnVeoR-23, LS-EnVeoR-2629, LS-EnVeoR-23-C, LS-EnVeoR-2629-C. Cardiovascular valve delivery system for use with the Medtronic CoreValve Evolut R system.
Reason for recall
Medtronic is recalling the EnVeo R Loading Systems because of the presence of particulate.
Data sourced from openFDA. This site is unofficial and independent of the FDA.