Heartware, Inc.: 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.

Recall number

Z-1428-2020

Recalling firm

Heartware, Inc.

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.

Status

Open, Classified

Initiated

2020-01-23

Posted

2020-03-09

Terminated

not on file

Reason

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

Root 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

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.

Lot, serial or model codes

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

510(k) numbers

not on file

PMA numbers

["P100047"]

Product code

DSQ

Firm FEI

3007042319

Firm city

Miami Lakes

Firm state

FL

Firm country

not on file

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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