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HeartWare HVAD System Battery Charger AC Adapter recallZ-1428-2020 · Heartware, Inc. · initiated Jan 23, 2020

Class I Open, Classified All recalls posted in March 2020

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Heartware, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

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

FDA root cause category: Device Design

What the company is doing

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].

Recall details

Recall number
Z-1428-2020
Recall class
Class I (most serious)
Status
Open, Classified
Initiated by the company
Jan 23, 2020
Posted by the FDA
Mar 9, 2020
Recalling firm
Heartware, Inc.
Quantity
5,489 devices total
Product code
DSQ
FDA submissions
P100047
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 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.

Code information (models, lots, serial numbers)

Show the full code information (12k characters)

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 devices under the same FDA submission

33 devices cleared under P100047 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.

Other products in the same recall event

The FDA groups related products into one recall event (event 84829).

Sources and updates

How recalls are matched to devices · Editorial policy · Report an error on this page