FDA Device recall Z-0745-2023

HeartWare HVAD Pump Kit, REF 1103

FDA Device
Class II
ongoing
Published 2022-12-28

On 2022-12-28 the FDA classified a Class II recall of HeartWare HVAD Pump Kit, REF 1103 by Heartware, citing 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 driv….

Read the official FDA Device notice

Agency	FDA Device
Recall number	Z-0745-2023
Classification	Class II
Status	ongoing
Initiated	2022-11-29
Published	2022-12-28
Last updated	2026-09-13 11:56 UTC
Company	Heartware
Distribution	n/a

Product

HeartWare HVAD Pump Kit, REF 1103

Reason

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.

Identifiers

code_info	UDI/DI 00888707003261, Serial Numbers: HW11011, HW11013, HW11019, HW11033, HW11036, HW11047, HW11060, HW11064, HW11067… UDI/DI 00888707003261, Serial Numbers: HW11011, HW11013, HW11019, HW11033, HW11036, HW11047, HW11060, HW11064, HW11067, HW11074, HW11075, HW11078, HW11086, HW11088, HW11094, HW11106, HW11107, HW11112, HW11113, HW11116, HW11120, HW11123, HW11126, HW11129, HW11140, HW11141, HW11146, HW11155, HW11157, HW11168, HW11171, HW11174, HW11181, HW11183, HW11187, HW11193, HW11201, HW11209, HW11210, HW11222, HW11224, HW11244, HW11263, HW11277, HW11299, HW11318, HW11332, HW11335, HW11338, HW11339, HW11347, HW11353, HW11356, HW11357, HW11364, HW11368, HW11383, HW11384, HW11385, HW11386, HW11388, HW11405, HW11413, HW11427, HW11442, HW11453, HW11463, HW11471, HW11478, HW11482, HW11488, HW11493, HW11494, HW11501, HW11504, HW11510, HW11514, HW11515, HW11516, HW11525, HW11530, HW11532, HW11537, HW11557, HW11558, HW11561, HW11565, HW11586, HW11598, HW11600, HW11609, HW11610, HW11611, HW11616, HW11624, HW11630, HW11631, HW11638, HW11639, HW11647, HW11648, HW11650, HW11654, HW11655, HW11658, HW11664, HW1166

code_info

UDI/DI 00888707003261, Serial Numbers: HW11011, HW11013, HW11019, HW11033, HW11036, HW11047, HW11060, HW11064, HW11067…

UDI/DI 00888707003261, Serial Numbers: HW11011, HW11013, HW11019, HW11033, HW11036, HW11047, HW11060, HW11064, HW11067, HW11074, HW11075, HW11078, HW11086, HW11088, HW11094, HW11106, HW11107, HW11112, HW11113, HW11116, HW11120, HW11123, HW11126, HW11129, HW11140, HW11141, HW11146, HW11155, HW11157, HW11168, HW11171, HW11174, HW11181, HW11183, HW11187, HW11193, HW11201, HW11209, HW11210, HW11222, HW11224, HW11244, HW11263, HW11277, HW11299, HW11318, HW11332, HW11335, HW11338, HW11339, HW11347, HW11353, HW11356, HW11357, HW11364, HW11368, HW11383, HW11384, HW11385, HW11386, HW11388, HW11405, HW11413, HW11427, HW11442, HW11453, HW11463, HW11471, HW11478, HW11482, HW11488, HW11493, HW11494, HW11501, HW11504, HW11510, HW11514, HW11515, HW11516, HW11525, HW11530, HW11532, HW11537, HW11557, HW11558, HW11561, HW11565, HW11586, HW11598, HW11600, HW11609, HW11610, HW11611, HW11616, HW11624, HW11630, HW11631, HW11638, HW11639, HW11647, HW11648, HW11650, HW11654, HW11655, HW11658, HW11664, HW1166

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0745-2023%22

RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.