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HeartWare HVAD System Battery Charger AC Adapter The HeartWare HVAD System is indicated for he...

FDA Device Recall #Z-1428-2020 — Class I — January 23, 2020

Recall Summary

Recall Number Z-1428-2020
Classification Class I — Serious risk
Date Initiated January 23, 2020
Status Ongoing
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm Heartware, Inc.
Location Miami Lakes, FL
Product Type Devices
Quantity 5,489 devices total

Product Description

HeartWare HVAD System Battery Charger AC Adapter The HeartWare HVAD System is indicated for hemodynamic support in patients with advanced, refractory left ventricular heart failure; either as a Bridge to Cardiac Transplantation (BTT), myocardial recovery, or as Destination Therapy (DT) in patients for whom subsequent transplantation is not planned.

Reason for Recall

Potential for an HVAD System user to mistakenly insert the Battery Charger AC Adapter into an HVAD Controller power port.

Distribution Pattern

No affected devices distributed within the US. International distribution to Australia, Austria, Belgium, Brazil, Canada, Chile, Colombia, Croatia, Czech Republic, Denmark, EGYPT, Estonia, Finland, France, Germany, Greece, Hong Kong, India, Israel, Italy, Japan, Kazakhstan, Korea, Korea, Republic of, Kuwait, Latvia, Lebanon, Lithuania, Luxembourg, Macedonia, Malaysia, Netherlands, New Zealand, Norway, Poland, Romania, Saudi Arabia, Serbia, Singapore, Slovakia, South Africa, Spain, Sweden, Switzerland, Taiwan, Taiwan, Province of China, Turkey, United Arab Emirates, United Kingdom, Vietnam.

Lot / Code Information

Model Number: 1640, all Serial Numbers. Known Model Numbers (Serial Numbers) GTIN Numbers: 1640CA (BAC004576) 00888707001298, 1640GB (BAC004765) 00888707001328, 1640GB (BAC004768) 00888707001328, 1640AR (BAC004772) 00888707001274, 1640IN (BAC004829) 00888707000543, 1640DE (BAC005530) 00888707001304, 1640CA (BAC005842) 00888707001298, 1640CA (BAC005854) 00888707001298, 1640BR (BAC005875) 00888707001281, 1640BR (BAC005876) 00888707001281, 1640GB (BAC005920) 00888707001328, 1640AU (BAC005966) 00888707001267, 1640AU (BAC005980) 00888707001267, 1640IN (BAC005997) 00888707000543, 1640AU (BAC006001) 00888707001267, 1640IL (BAC006027) 00888707001335, 1640IT (BAC006032) 00888707001342, 1640IN (BAC006033) 00888707000543, 1640IN (BAC006034) 00888707000543, 1640IN (BAC006035) 00888707000543, 1640IN (BAC006036) 00888707000543, 1640IL (BAC006037) 00888707001335, 1640IL (BAC006038) 00888707001335, 1640GB (BAC006039) 00888707001328, 1640DE (BAC006040) 00888707001304, 1640DE (BAC006041) 00888707001304, 1640DE (BAC006056) 00888707001304, 1640CA (BAC006087) 00888707001298, 1640IN (BAC006102) 00888707000543, 1640IN (BAC006104) 00888707000543, 1640DE (BAC090005) 00888707002325, 1640CH (BAC090006) 00888707002318, 1640CH (BAC090012) 00888707002318, 1640GB (BAC090079) 00888707002332, 1640IT (BAC090082) 00888707002363, 1640IT (BAC090083) 00888707002363, 1640GB (BAC090084) 00888707002332, 1640CH (BAC090165) 00888707002318, 1640CH (BAC090166) 00888707002318, 1640DE (BAC090167) 00888707002325, 1640DE (BAC090168) 00888707002325, 1640DE (BAC090170) 00888707002325, 1640GB (BAC090171) 00888707002332, 1640GB (BAC090172) 00888707002332, 1640IT (BAC090173) 00888707002363, 1640IT (BAC090174) 00888707002363, 1640DE (BAC090175) 00888707002325, 1640IN (BAC090237) 00888707002356, 1640IN (BAC090238) 00888707002356, 1640DE (BAC090414) 00888707002325, 1640DE (BAC090415) 00888707002325, 1640DE (BAC090416) 00888707002325, 1640DE (BAC090417) 00888707002325, 1640DE (BAC090447) 00888707002325, 1640DE (BAC090448) 00888707002325, 1640IT (BAC090611) 00888707002363, 1640AU (BAC090659) 00888707002288, 1640AU (BAC090660) 00888707002288, 1640CA (bac090661) 00888707002301, 1640CA (BAC090662) 00888707002301, 1640GB (BAC090663) 00888707002332, 1640GB (BAC090664) 00888707002332, 1640IT (BAC090665) 00888707002363, 1640DE (BAC090666) 00888707002325, 1640DE (BAC090667) 00888707002325, 1640AU (BAC090732) 00888707002288, 1640AU (bac090733) 00888707002288, 1640GB (BAC090734) 00888707002332, 1640GB (BAC090735) 00888707002332, 1640DE (BAC090864) 00888707002325, 1640DE (BAC090976) 00888707002325, 1640DE (BAC091324) 00888707003018, 1640DE (BAC091325) 00888707003018, 1640DE (BAC091326) 00888707003018, 1640DE (BAC091327) 00888707003018, 1640DE (BAC091330) 00888707003018, 1640DE (BAC091331) 00888707003018, 1640DE (BAC091332) 00888707003018, 1640DE (BAC091333) 00888707003018, 1640DE (BAC091420) 00888707003018, 1640DE (BAC091421) 00888707003018, 1640CA (BAC091690) 00888707003056, 1640CA (BAC091691) 00888707003056, 1640DE (BAC091695) 00888707003018, 1640DE (BAC091696) 00888707003018, 1640DE (BAC091697) 00888707003018, 1640DE (BAC091698) 00888707003018, 1640DE (BAC091699) 00888707003018, 1640DE (BAC091700) 00888707003018, 1640DE (BAC091701) 00888707003018, 1640DE (BAC091702) 00888707003018, 1640DE (BAC091703) 00888707003018, 1640DE (BAC091704) 00888707003018, 1640GB (BAC091738) 00888707003025, 1640GB (BAC091739) 00888707003025, 1640DE (BAC091741) 00888707003018, 1640GB (BAC091743) 00888707003025, 1640GB (BAC091744) 00888707003025, 1640DE (BAC091758) 00888707003018, 1640DE (BAC091811) 00888707003018, 1640DE (BAC091812) 00888707003018, 1640DE (BAC092205) 00888707003018, 1640DE (BAC092206) 00888707003018, 1640IT (BAC092283) 00888707003032, 1640GB (BAC092289) 00888707003025, 1640JP (BAC092290) 00888707002370, 1640JP (BAC092292) 00888707002370, 1640CA (BAC092294) 00888707003056, 1640DE (BAC092332) 00888707003018, 1640DE (BAC092333) 00888707003018, 1640DE (BAC092334) 00888707003018, 1640DE (BAC092335) 00888707003018, 1640DE (BAC092391) 00888707003018, 1640IN (BAC092396) 00888707003049, 1640JP (BAC092459) 00888707002370, 1640DE (BAC092495) 00888707003018, 1640DE (BAC092506) 00888707003018, 1640DE (BAC092556) 00888707003018, 1640DE (BAC092557) 00888707003018, 1640DE (BAC092558) 00888707003018, 1640DE (BAC092559) 00888707003018, 1640DE (BAC092560) 00888707003018, 1640JP (BAC092595) 00888707002370, 1640JP (BAC092680) 00888707002370, 1640JP (BAC092681) 00888707002370, 1640JP (BAC092682) 00888707002370, 1640JP (BAC092683) 00888707002370, 1640JP (BAC092684) 00888707002370, 1640JP (BAC092685) 00888707002370, 1640JP (BAC092687) 00888707002370, 1640JP (BAC092689) 00888707002370, 1640JP (BAC092690) 00888707002370, 1640GB (BAC092748) 00888707003025, 1640GB (BAC092752) 00888707003025, 1640DE (BAC092760) 00888707003018, 1640IN (BAC100001) 00888707005913, 1640IN (BAC100002) 00888707005913, 1640GB (BAC100003) 00888707005890, 1640GB (BAC100004) 00888707005890, 1640DE (BAC100005) 00888707005883, 1640CA (BAC100006) 00888707005869, 1640IT (BAC100009) 00888707005920, 1640IT (BAC100010) 00888707005920, 1640CA (BAC100015) 00888707005869, 1640DE (BAC100030) 00888707005883, 1640DE (BAC100031) 00888707005883, 1640CA (BAC100256) 00888707005869, 1640CA (BAC100349) 00888707005869, 1640DE (BAC100385) 00888707005883, 1640CA (BAC100391) 00888707005869, 1640GB (BAC100402) 00888707005890, 1640IT (BAC100412) 00888707005920, 1640GB (BAC100413) 00888707005890, 1640GB (BAC100414) 00888707005890, 1640GB (BAC100415) 00888707005890, 1640DE (BAC100451) 00888707005883, 1640DE (BAC100452) 00888707005883, 1640GB (BAC100525) 00888707005890, 1640CH (BAC100597) 00888707005876, 1640IL (BAC100599) 00888707005906, 1640CH (BAC100600) 00888707005876, 1640DE (BAC100725) 00888707005883, 1640GB (BAC100742) 00888707005890, 1640GB (BAC100743) 00888707005890, 1640GB (BAC100866) 00888707005890, 1640GB (BAC100867) 00888707005890, 1640GB (BAC100868) 00888707005890, 1640DE (BAC000048) 00888707001304, 1640DE (BAC000122) 00888707001304, 1640DE (BAC000123) 00888707001304, 1640DE (BAC000125) 00888707001304, 1640CA (BAC000544) 00888707001298, 1640DE (BAC002505) 00888707001304, 1640DE (BAC091485) 00888707003018, 1640DE (BAC091486) 00888707003018, 1640DE (BAC091487) 00888707003018, 1640DE (BAC091488) 00888707003018, 1640DE (BAC091489) 00888707003018, 1640DE (BAC091494) 00888707003018, 1640DE (BAC091495) 00888707003018, 1640DE (BAC091496) 00888707003018, 1640DE (BAC091497) 00888707003018, 1640DE (BAC091498) 00888707003018, 1640DE (BAC091499) 00888707003018, 1640DE (BAC091500) 00888707003018, 1640DE (BAC091501) 00888707003018, 1640DE (BAC091502) 00888707003018, 1640DE (BAC091503) 00888707003018, 1640DE (BAC091504) 00888707003018, 1640DE (BAC091505) 00888707003018, 1640DE (BAC091506) 00888707003018, 1640DE (BAC091507) 00888707003018, 1640DE (BAC091539) 00888707003018, 1640IN (BAC091710) 00888707003049, 1640IN (BAC091711) 00888707003049, 1640IT (BAC091715) 00888707003032, 1640CA (BAC091716) 00888707003056, 1640CA (BAC091717) 00888707003056, 1640CA (BAC091718) 00888707003056, 1640CA (BAC091719) 00888707003056, 1640IT (BAC091735) 00888707003032, 1640IT (BAC091736) 00888707003032, 1640IT (BAC091737) 00888707003032, 1640GB (BAC091742) 00888707003025, 1640GB (BAC091805) 00888707003025, 1640GB (BAC091806) 00888707003025, 1640GB (BAC091807) 00888707003025, 1640GB (BAC091808) 00888707003025, 1640DE (BAC091813) 00888707003018, 1640DE (BAC091814) 00888707003018, 1640JP (BAC091961) 00888707002370, 1640AU (BAC000247) 00888707001267, 1640AU (BAC000679) 00888707001267, 1640AU (BAC001066) 00888707001267, 1640AU (BAC001076) 00888707001267, 1640DE (BAC001196) 00888707001304, 1640CH (BAC001384) 00888707001311, 1640IL (BAC001707) 00888707001335, 1640CH (BAC001811) 00888707001311, 1640CH (BAC001812) 00888707001311, 1640IT (BAC001815) 00888707001342, 1640CH (BAC001818) 00888707001311, 1640IT (BAC001828) 00888707001342, 1640AR (BAC001852) 00888707001274, 1640BR (BAC001980) 00888707001281, 1640IL (BAC001982) 00888707001335, 1640IN (BAC002000) 00888707000543, 1640AR (BAC002157) 00888707001274, 1640AU (BAC002192) 00888707001267, 1640AU (BAC002333) 00888707001267, 1640JP (BAC002547) 00888707001359, 1640JP (BAC002548) 00888707001359, 1640CA (BAC002777) 00888707001298, 1640CA (BAC002778) 00888707001298, 1640CA (BAC002779) 00888707001298, 1640CA (BAC002780) 00888707001298, 1640CA (BAC002781) 00888707001298, 1640CA-CLIN (BAC003225) 00888707001571, 1640CA-CLIN (BAC003226) 00888707001571, 1640CA-CLIN (BAC003227) 00888707001571, 1640CA-CLIN (BAC003228) 00888707001571, 1640DE (BAC003345) 00888707001304, 1640DE (BAC003346) 00888707001304, 1640DE (BAC003349) 00888707001304, 1640GB (BAC003354) 00888707001328, 1640GB (BAC003357) 00888707001328, 1640GB (BAC003358) 00888707001328, 1640GB (BAC003359) 00888707001328, 1640GB (BAC003462) 00888707001328, 1640DE (BAC004553) 00888707001304, 1640CA (BAC004575) 00888707001298, 1640CH (BAC004665) 00888707001311, 1640IL (BAC004763) 00888707001335, 1640IL (BAC004766) 00888707001335, 1640GB (BAC004769) 00888707001328, 1640AR (BAC004771) 00888707001274, 1640AU (BAC004773) 00888707001267, 1640IT (BAC004774) 00888707001342, 1640GB (BAC004775) 00888707001328, 1640IT (BAC004777) 00888707001342, 1640IN (BAC004830) 00888707000543, 1640DE (BAC005320) 00888707001304, 1640IN (BAC005967) 00888707000543, 1640IN (BAC005968) 00888707000543, 1640IN (BAC005969) 00888707000543, 1640IN (BAC005970) 00888707000543, 1640AU (BAC005973) 00888707001267, 1640AU (BAC005981) 00888707001267, 1640IL (BAC006018) 00888707001335, 1640IL (BAC006019) 00888707001335, 1640IL (BAC006020) 00888707001335, 1640IL (BAC006021) 00888707001335, 1640IT (BAC006022) 00888707001342, 1640IT (BAC006023) 00888707001342, 1640IT (BAC006024) 00888707001342, 1640IT (BAC006025) 00888707001342, 1640IN (BAC006103) 00888707000543, 1640IN (BAC006105) 00888707000543, 1640IL (BAC090222) 00888707002349, 1640IL (BAC090226) 00888707002349, 1640GB (BAC090437) 00888707002332, 1640IT (BAC092284) 00888707003032, 1640IN (BAC092285) 00888707003049, 1640IN (BAC092287) 00888707003049, 1640GB (BAC092288) 00888707003025, 1640IN (BAC092397) 00888707003049, 1640IN (BAC092460) 00888707003049, 1640IN (BAC092465) 00888707003049, 1640JP (BAC092592) 00888707002370, 1640JP (BAC092593) 00888707002370, 1640DE (BAC006047) 00888707001304, 1640DE (BAC006002) 00888707001304, 1640GB (BAC006107) 00888707001328, 1640GB (BAC006108) 00888707001328, 1640AU (BAC005907) 00888707001267, 1640AU (BAC001853) 00888707001267, 1640AU (BAC001856) 00888707001267, 1640DE (BAC003922) 00888707001304, 1640DE (BAC004552) 00888707001304, 1640DE (BAC004347) 00888707001304, 1640IT (BAC004173) 00888707001342, 1640GB (BAC004836) 00888707001328, 1640DE (BAC003839) 00888707001304, 1640IN (BAC004701) 00888707000543, 1640CH (BAC004116) 00888707001311, 1640DE (BAC004350) 00888707001304, 1640DE (BAC004176) 00888707001304, 1640DE (BAC004354) 00888707001304, 1640DE (BAC004348) 00888707001304, 1640DE (BAC004351) 00888707001304, 1640DE (BAC003112) 00888707001304, 1640DE (BAC003347) 00888707001304, 1640GB (BAC003451) 00888707001328, 1640GB (BAC001199) 00888707001328, 1640GB (BAC001820) 00888707001328, 1640GB (BAC001823) 00888707001328, 1640DE (BAC002494) 00888707001304, 1640DE (BAC002506) 00888707001304, 1640GB (BAC000809) 00888707001328, 1640CA (BAC002260) 00888707001298, 1640CA (BAC002271) 00888707001298, 1640CA (BAC002335) 00888707001298, 1640JP (BAC002631) 00888707001359, 1640DE (BAC001834) 00888707001304, 1640DE (BAC001829) 00888707001304, 1640DE (BAC000030) 00888707001304, 1640DE (BAC001833) 00888707001304, 1640DE (BAC000026) 00888707001304, 1640CA (BAC001804) 00888707001298, 1640CA (BAC001808) 00888707001298, 1640CA (BAC002334) 00888707001298, 1640DE (BAC001830) 00888707001304, 1640DE (BAC000065) 00888707001304, 1640DE (BAC000069) 00888707001304, 1640DE (BAC000070) 00888707001304, 1640DE (BAC000071) 00888707001304

Other Recalls from Heartware, Inc.

Recall # Classification Product Date
Z-0478-2024 Class II PUMP 1103 HVAD (HeartWare Ventricular Assist De... Oct 31, 2023
Z-0482-2024 Class II HVAD (HeartWare Ventricular Assist Device) STER... Oct 31, 2023
Z-0481-2024 Class II PUMP 1104 HVAD (HeartWare Ventricular Assist De... Oct 31, 2023
Z-0479-2024 Class II PUMP 1104 HVAD (HeartWare Ventricular Assist De... Oct 31, 2023
Z-0475-2024 Class II HVAD (HeartWare Ventricular Assist Device) STER... Oct 31, 2023

Frequently Asked Questions

Contact your physician immediately if you use an electrical device or implant affected by this recall. For external devices (monitors, pumps), stop using the device and contact the manufacturer for a replacement. For implanted devices (pacemakers, ICDs), your cardiologist will assess whether you need device replacement surgery — the decision depends on how dependent you are on the device and the actual failure rate observed in the field. Do not attempt to repair or modify a recalled electrical medical device yourself. Monitor for any new or unusual symptoms and report them to your doctor.

Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.

Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.

What Should You Do?

Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.

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