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HeartWare HVAD Pump Kit, REF MCS1705PU

FDA Recall #Z-0750-2023 — Class II — November 29, 2022

Recall #Z-0750-2023 Date: November 29, 2022 Classification: Class II Status: Ongoing

Product Description

HeartWare HVAD Pump Kit, REF MCS1705PU

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.

Recalling Firm

Heartware, Inc. — Miami Lakes, FL

Classification

Class II — May cause temporary or medically reversible adverse health consequences.

Product Type

Devices

Product Quantity

146 units

Distribution

Worldwide distribution.

Code Information

UDI/DI 008887070090441, Serial Numbers: HW41765, HW42068, HW42069, HW42070, HW42071, HW42081, HW42082, HW42083, HW42176, HW42179, HW42184, HW42195, HW42202, HW42205, HW42261, HW42267, HW42297, HW42298, HW42301, HW42364, HW42368, HW42372, HW42375, HW42379, HW42397, HW42400, HW42401, HW42403, HW42404, HW42405, HW42420, HW42438, HW42439, HW42484, HW42499, HW42522, HW42573, HW42581, HW42582, HW42585, HW42586, HW42591, HW42595, HW42596, HW42610, HW42611, HW42612, HW42614, HW42615, HW42618, HW42681, HW42685, HW42691, HW42692, HW42693, HW42694, HW42695, HW42696, HW42697, HW42699, HW42701, HW42704, HW42705, HW42706, HW42713, HW42826, HW42832, HW42839, HW42845, HW42846, HW42847, HW42853, HW42924, HW42925, HW42929, HW42930, HW42934, HW42935, HW42936, HW42945, HW42946, HW42950, HW42951, HW42954, HW42956, HW42957, HW42958, HW42959, HW42963, HW42972, HW42975, HW42977, HW42978, HW42979, HW42980, HW42982, HW42984, HW42985, HW42986, HW43015, HW43019, HW43027, HW43032, HW43037, HW43038, HW43039, HW43040, HW43042, HW43044, HW43047, HW43048, HW43052, HW43053, HW43054, HW43062, HW43064, HW43109, HW43114, HW43115, HW43116, HW43125, HW43157, HW43187, HW43188, HW43197, HW43219, HW43240, HW43247, HW43248, HW43249, HW43251, HW43253, HW43255, HW43257, HW43258, HW43262, HW43268, HW43270, HW43276, HW43313, HW43316, HW43322, HW43352, HW43366, HW43453, HW43489

Status

Ongoing

Voluntary / Mandated

Voluntary: Firm initiated

What Should You Do?

Stop using this medical device immediately and consult your healthcare provider. Contact the recalling firm for instructions on return or replacement. If you experienced an adverse event, inform your doctor.

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