Recall Z-1993-2023— Heartware, Inc.
Class II · Ongoing
Class II FDA medical device recall by Heartware, Inc., initiated 2023-05-16. FDA's recall record names no specific 510(k) clearance for this event. Product: HeartWare Ventricular Assist Device System. a) Monitor 1521US Explore Tech, b) Monitor 1521GB Explore Tech, c) Monitor 1521IL Explore Tech, d) Monitor 1521DE Explore Tech. Reason: Medtronic has identified that the logfiles downloaded from the recently updated Model 1521 monitors (Serial Numbers: MON4xxxxxx for OUS and MON5xxxxxx for US), are unable to be processed by the Autologs web portal..
- Recalling firm
- Heartware, Inc.
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2023-05-16
- Firm location
- Miami Lakes, FL, United States
Product description
HeartWare Ventricular Assist Device System. a) Monitor 1521US Explore Tech, b) Monitor 1521GB Explore Tech, c) Monitor 1521IL Explore Tech, d) Monitor 1521DE Explore Tech
Reason for recall
Medtronic has identified that the logfiles downloaded from the recently updated Model 1521 monitors (Serial Numbers: MON4xxxxxx for OUS and MON5xxxxxx for US), are unable to be processed by the Autologs web portal.
Data sourced from openFDA. This site is unofficial and independent of the FDA.