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Heartware, Inc. Recall 89559

Description: HeartWare Ventricular Assist Device (HVAD) System

Heartware, Inc. Recall 89559 Information

Mandated?Voluntary: Firm initiated
Recall NumberZ-0726-2022
Event ID89559
Event DescriptionHeartWare Ventricular Assist Device (HVAD) System
Product TypeDevices
DistributionDistribution throughout the United States. OUS distribution in Argentina, Armenia, Australia, Austria, Belgium, Brazil, Canada, Chile, Colombia, Croatia, Czech Republic, Denmark, Egypt, Estonia, Finland, France, Germany, Greece, Hong Kong, Hungary, India, Israel, Italy, Japan, Kazakhstan, Korea (South), Kuwait, Latvia, Lebanon, Lithuania, Luxembourg, Malaysia, Mauritius, Netherlands, New Zealand, North Macedonia, Norway, Pakistan, Poland, Qatar, Romania, Saudi Arabia, Serbia, Singapore, Slovakia, South Africa, Spain, Sweden, Switzerland, Taiwan, Turkey, Ukraine, United Arab Emirates, United Kingdom, and Vietnam.
Quantity197,889 units
Recall ReasonUpdated cleaning instructions are being provided for the Controller AC Adapter, DC Adapter, and Battery to provide clarity to avoid cleaning the power source connector pins, as this could remove the lubricant that is applied to the pins as a mitigation for power switching.
Device Classification20220316
Device Code InfoAll lots/serials for the following product model numbers: 1440, 1400, 1401, 1401AU, 1401BR, 1401CA, 1401CH, 1401DE, 1401GB, 1401IL, 1401IN, 1401IT, 1401JP, 1401US, 1403US, 1407AR, 1407AU, 1407BR, 1407CA, 1407CA-CLIN, 1407CH, 1407DE, 1407GB, 1407IL, 1407IN, 1407IT, 1407JP, 1407KR, 1425AU, 1425CA, 1425DE, 1425GB, 1425IL, 1425IT, 1425US, 1430AR, 1430AU, 1430CA, 1430CH, 1430DE, 1430GB, 1430IL, 1430IN, 1430IT, 1430JP, 1430US, 1440, 1650, 1650, 1650CA-CLIN, 1650DE
Center Classification Date20220304
Recall Initiation Date20220127
Recalling FirmHeartware, Inc.
Initial Notification Letter
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