FDA Device Recall Z-1428-2020

Heartware, Inc. · Miami Lakes, FL

Class I — life-threatening Ongoing

Highest impact — Class I device recall — FDA determination that use of, or exposure to, the device will cause serious adverse health consequences or death.

Device

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.

Lot / serial / GTIN: 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

Quantity: 5,489 devices total

Reason for recall

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

Recall record

Recall number: Z-1428-2020
Classification: Class I
Status: Ongoing
Voluntary or mandated: Voluntary: Firm initiated
Firm notification: Letter
Distribution: 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.
Recall initiated: 2020-01-23
Classified by FDA Center: 2020-03-09
FDA published: 2020-03-18
Recalling firm: Heartware, Inc.
Firm location: Miami Lakes, FL

Operational response

A Class I device recall indicates a strong likelihood of serious adverse health consequence or death from continued use. Identify affected units by serial number, lot, or GTIN against your inventory and against implanted-device patient registry. Pull affected inventory from active use immediately. For implanted devices, follow the recalling firm’s patient-notification protocol; in most cases this requires informing affected patients and their treating physicians directly.

For the official FDA enforcement record, see FDA's Recall Search.

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