Drug & Device Safety Atlas

FDA recall record · openFDA

Heartware, Inc.

10 FDA recalls on record (2023) — 10 device. 10 still ongoing.

0
Class I (most serious)
10
Class II
0
Class III
10
ongoing

How to read this. A recall count is not a quality verdict — large manufacturers recall more simply by volume, and a voluntary recall is the safety system working as intended. The signal to weight is the Class I count (the FDA's most-serious tier — reasonable probability of serious harm or death) and whether recalls are still ongoing. Most recalls are Class II/III. "Ongoing" reflects openFDA's last-published status — device recalls often stay marked ongoing long after they're resolved in practice; confirm current status at the FDA.

Most common reasons

Updates to the HVAD system instructions for use (IFU) and patient manual (PM) will be provided. These updates will clari 9
Medtronic has identified that the logfiles downloaded from the recently updated Model 1521 monitors (Serial Numbers: MON 1

Recalls

PUMP 1103 HVAD (HeartWare Ventricular Assist Device) IMPLANT KIT, Model Number 1103 Class II 2023-10-31 HVAD (HeartWare Ventricular Assist Device) STERILE IMPLANT KIT/IMPLANT KIT OUS, Model Number 1205 Class II 2023-10-31 PUMP 1104 HVAD (HeartWare Ventricular Assist Device) IMPLANT KIT EN JA, Model Number 1104JP Class II 2023-10-31 HVAD (HeartWare Ventricular Assist Device) STERILE IMPLANT KIT, Model Number 1100 Class II 2023-10-31 PUMP 1104 HVAD (HeartWare Ventricular Assist Device) IMPLANT KIT, Model Number 1104 Class II 2023-10-31 PUMP MCS1705PU HVAD (HeartWare Ventricular Assist Device) IMPLANT KIT US, Model Number MCS1705PU Class II 2023-10-31 STERILE HVAD (HeartWare Ventricular Assist Device) PUMP (US), Model Number 1101 Class II 2023-10-31 HVAD (HeartWare Ventricular Assist Device) STERILE IMPLANT KIT, Model Number 1102 Class II 2023-10-31 1104CA-CLIN - HVAD (HeartWare Ventricular Assist Device) PUMP, Model Number 1104CA-CLIN Class II 2023-10-31 HeartWare Ventricular Assist Device System. a) Monitor 1521US Explore Tech, b) Monitor 1521GB Explore Tech, c) Monit Class II 2023-05-16

RECORDED — these are the FDA's published recall enforcement records (openFDA). Recalls are listed under the exact firm name as filed; a large manufacturer may also file under name variants, so this may not be the company's complete cross-variant record — confirm at the FDA recall database. This page informs and routes; it is not medical advice or a verdict on the company.

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