Class 1 Device Recall HeartWare HVAD System Battery Charger AC Adapter

• Date Initiated by Firm: January 23, 2020
• Date Posted: March 09, 2020
• Recall Status: Open, Classified
• Recall Number: Z-1428-2020
• Recall Event ID: 84829
• PMA Number: P100047
• Product Classification: Ventricular (assist) bypass - Product Code DSQ
• Product: 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.
• 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
• Recalling Firm/ Manufacturer: Heartware, Inc.; 14400 Nw 60th Ave; Miami Lakes FL 33014-2807
• For Additional Information Contact: 877-367-4823
• Manufacturer Reason for Recall: Potential for an HVAD System user to mistakenly insert the Battery Charger AC Adapter into an HVAD Controller power port.
• FDA Determined Cause: Device Design
• Action: Heartware notified customers on about 01/23/2020 via "Urgent Field Safety Notice" letter. Customers were notified of the potential for an HVAD System user to mistakenly insert the Battery Charger AC Adapter into an HVAD Controller power port. When this occurs, communication circuits between the battery and the Controller may be damaged. If circuit damage occurs, it will be necessary to exchange the Controller to restore communication between the batteries and Controller. Instructions included to advise patients to carefully follow the guidance provided in the patient manual related to connecting a power source. Pay attention when connecting and disconnecting power supply cables to ensure users verify the correct cable is being connected to their Controller. Patients were instructed to report any persistent, unexpected audible tones to their Clinician for additional instructions. Additional instructions included to ensure all personnel within your organization or any customers if further distributed are notified of this recall. If you have any questions, please contact the Cardiac and Vascular Group Customer Focused Quality at 763-526-2513 or by email to: carlos.j.alfonzo@medtronic.com.
• Quantity in Commerce: 5,489 devices total
• 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.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.

• PMA Database: PMAs with Product Code = DSQ