CLASS II ONGOING Device recall · Reported 28 Dec 2022 · FDA Enforcement Report

HeartWare Model recalled

Heartware is recalling HeartWare Model 1101. The recall was initiated on 29 Nov 2022 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesSerial Numbers: HW1146, HW1205, HW1209, HW1247, HW1454, HW1533, HW1634, HW1688, HW1951, HW200, HW281, HW378, HW383, HW469, HW492, HW557, HW816, HW933, HW1091, HW1143, HW1144, HW1200, HW1242, HW1243, HW1244, HW1276, HW1280, HW1398, HW1403, HW1415, HW1437, HW1439, HW1456, HW1524, HW1553, HW1555, HW1637, HW1694, HW1697, HW1769, HW1816, HW1818, HW1963, HW198, hw209, HW229, HW257, HW290, HW304, HW310, HW321, HW323, HW433, HW467, HW482, HW488, HW536, HW562, HW568, HW578, HW581, HW590, HW591, HW610, HW635, HW645, HW678, HW795, HW796, HW798, HW801, HW819, HW825, HW827, HW888, HW889, HW922, HW978, HW107, HW210, HW216, HW526

Quantity recalled82 units

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-0743-2023
FDA event ID: 91281
Recalling firm: Heartware, Miami Lakes, FL
Classification: Class II
Status: Ongoing
Recall initiated: 29 Nov 2022
FDA classified: 21 Dec 2022
Reported: 28 Dec 2022
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Other Medical Devices

Timeline

29 Nov 2022	Recall initiated by company
21 Dec 2022	Classified by FDA	+22 days
28 Dec 2022	Published in enforcement report	+7 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

Over time, the driveline cover may become hardened, creating difficulty or an inability to slide the cover back to access the driveline to controller connector. Access to the driveline connector may be delayed, which may result in patient harm from a prolonged pump stop, if an urgent driveline connection or controller issue needs to be addressed. In the event a hardened driveline cover is observed, contact your Medtronic field representative for further assessment and/or servicing.

Product as listed by the FDA

HeartWare Model 1101

Where it was distributed

Worldwide distribution.

Questions about this recall

Why was it recalled?

Which lots are affected?

Serial Numbers: HW1146, HW1205, HW1209, HW1247, HW1454, HW1533, HW1634, HW1688, HW1951, HW200, HW281, HW378, HW383, HW469, HW492, HW557, HW816, HW933, HW1091, HW1143, HW1144, HW1200, HW1242, HW1243, HW1244, HW1276, HW1280, HW1398, HW1403, HW1415, HW1437, HW1439, HW1456, HW1524, HW1553, HW1555, HW1637, HW1694, HW1697, HW1769, HW1816, HW1818, HW1963, HW198, hw209, HW229, HW257, HW290, HW304, HW310, HW321, HW323, HW433, HW467, HW482, HW488, HW536, HW562, HW568, HW578, HW581, HW590, HW591, HW610, HW635, HW645, HW678, HW795, HW796, HW798, HW801, HW819, HW825, HW827, HW888, HW889, HW922, HW978, HW107, HW210, HW216, HW526

Where was it sold?

Worldwide distribution.

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

Other products in this recall event

7 other products · FDA event 91281

This product is part of a recall event; the main page for the event is HeartWare Model recalled.

Reported	Class	Recall	Company	Reason	Where
28 Dec 2022	CLASS II	HeartWare Model recalled	Heartware	Other	FL
28 Dec 2022	CLASS II	HVAD Pump Kit recalled by Heartware	Heartware	Other	FL
28 Dec 2022	CLASS II	HVAD Pump Kit recalled by Heartware	Heartware	Other	FL
28 Dec 2022	CLASS II	HVAD Pump Kit recalled by Heartware	Heartware	Other	FL
28 Dec 2022	CLASS II	HeartWare Model recalled	Heartware	Other	FL
28 Dec 2022	CLASS II	HVAD Pump Kit recalled by Heartware	Heartware	Other	FL
28 Dec 2022	CLASS II	HVAD Pump Kit recalled by Heartware	Heartware	Other	FL

More recalls from Heartware

All 69

Reported	Class	Recall	Company	Reason	Where
13 Dec 2023Device	CLASS II	1104CA-Clin - Hvad (HeartWare Ventricular Assist Device) Pump recalled	Heartware	Device Malfunction	FL
13 Dec 2023Device	CLASS II	Hvad (HeartWare Ventricular Assist Device) Sterile Implant Kit recalled	Heartware	Device Malfunction	FL
13 Dec 2023Device	CLASS II	Sterile Hvad (HeartWare Ventricular Assist Device) Pump (US) recalled	Heartware	Device Malfunction	FL
13 Dec 2023Device	CLASS II	Pump MCS1705PU Hvad (HeartWare Ventricular Assist Device) recalled	Heartware	Device Malfunction	FL
13 Dec 2023Device	CLASS II	Hvad (HeartWare Ventricular Assist Device) Sterile Implant Kit recalled	Heartware	Device Malfunction	FL

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