The FDA announced on Feb. 26, 2021, that Heartware, Inc. is recalling Instructions for Use and Patient Manuals for the HeartWare HVAD System to update alarm duration descriptions. This recall affects devices distributed worldwide as of the announcement date.
How to tell if you have it
- Heartware HVAD pump implant kits Models 1100, 1101, 1102, 1103, 1104, 1104JP, 1205, and MCS1705PU
- Heartware HVAD controller kits Models 1403US, 1407AU, 1407CA, 1407CH, 1407DE, 1407GB, 1407IL, 1407IN, 1407IT, 1407JP, 1407KR, 1420, and 1420JP
- Heartware HVAD controller AC adapter Models 1430AR, 1430AU, 1430CA, 1430CH, 1430DE, 1430GB, 1430IL, 1430IN, 1430IT, 1430JP, and 1430US
- Heartware HVAD controller DC Adapter Model 1440
- Heartware HVAD data cable - monitor Model 1575
- Heartware HVAD battery pack Models 1650, 1650CA-CLIN, and 1650DE
- Heartware HVAD patient pack Model 1475
- Heartware HVAD waist packs Models 2050, 2050IL, and 2050US
- Heartware HVAD shoulder packs Models 2060, 2060IL, and 2060US
The hazard
The recall updates the Instructions for Use to advise clinicians that alarms resolving after a very short period may indicate an intermittent problem. The Patient Manual is updated to instruct patients to contact clinicians if they cannot identify an alarm before it clears, as this might also mean there is an intermittent problem.
Context
GovInfoNow's records show Heartware, Inc. has had 17 other recalls on record since Aug. 28, 2018. Other recent recalls of similar products include Heartware PUMP 1104 HVAD Implant Kit Recall (Oct. 31, 2023), Heartware Ventricular Assist Device Monitors recall (May 16, 2023), and Heartware HVAD Pump Kit REF 1104JP recall (Nov. 29, 2022). Other recent recalls of similar products include ICU Medical Plum Duo Infusion System recall (Dec. 15, 2025), Philips IntelliVue MX50 recall (Oct. 31, 2025), and Boston Scientific LUX-Dx Cardiac Monitor System Recall (Aug. 6, 2026).