Z-1428-2020Class I

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

Name: Z-1428-2020 HeartWare HVAD System Battery Charger AC Adapter The HeartWare HVAD System is indicated for hemodynamic...
Creator: Heartware, Inc.
Published: 2020-01-23
License: https://open.fda.gov/license/

HeartWare, Inc. / initiated 2020-01-23 / Open, Classified / root cause: design

FDA source

Heartware, Inc. began a recall of HeartWare HVAD System Battery Charger AC Adapter The HeartWare HVAD System is indicated for hemodynamic support in patients with advanced, refractory left... on 2020-01-23. FDA classified it as Class I and gives the reason as "Potential for an HVAD System user to mistakenly insert the Battery Charger AC Adapter into an HVAD Controller power port". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as design.

Recall record

Recall number: Z-1428-2020
Classification: Class I
Status: Open, Classified
Initiated: 2020-01-23
Posted: 2020-03-09
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.
Product code: DSQ Ventricular (Assist) Bypass
Reason for recall: Potential for an HVAD System user to mistakenly insert the Battery Charger AC Adapter into an HVAD Controller power port.
Root cause tag: design
FDA 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: [email protected].
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.
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1428-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1427-2020	Class I	Ongoing	Voluntary: Firm initiated	2020-03-18	2020-03-09
Z-1428-2020	Class I	Ongoing	Voluntary: Firm initiated	2020-03-18	2020-03-09

Product code DSQ

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)