Heartware, Inc.: HeartWare Model 1101

Recall number

Z-0743-2023

Recalling firm

Heartware, Inc.

Product

HeartWare Model 1101

Status

Open, Classified

Initiated

2022-11-29

Posted

2022-12-21

Terminated

not on file

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.

Root cause

Device Design

Action

The firm issued an URGENT: MEDICAL DEVICE COMMUNICATION to the healthcare providers on 11/29/2022 by UPS 2-day delivery. The letter explained the issue and provided the following: "A. Patient Management Recommendations: In consultation with our Independent Practitioner Quality Panel, Medtronic is providing the following patient management recommendations: "Prior to exchanging a controller in the clinic, check to ensure the driveline cover is not stuck or hardened and can be pulled back from the driveline connector, per the instructions below.This may allow for early detection of the issue if the driveline cover is noticeably harder to manipulate but can still be moved. "During routine clinic visits, check to ensure that the driveline cover is not stuck or hardened and can be pulled back from the driveline connector. Instructions for Evaluating Driveline Cover: While immobilizing the controller, push the driveline towards the controller and pull the driveline cover back from the flange with a side-to-side wiggle motion (this may require support from a second person). DO NOT pull the driveline cover with excessive force or use a twisting motion as this may damage the driveline connector or dislodge the driveline connection. "If it is determined that a driveline cover is hardened or stuck, please contact your Medtronic field representative to evaluate the need to perform a field service procedure to remove the driveline cover. "As a part of the servicing procedure, risks will be discussed to determine the servicing plan, including deciding if the driveline cover will be replaced if removed. If the driveline cover is removed and not replaced, care and maintenance of the driveline will remain the same without a driveline cover, however care should be taken to avoid the ringed, grooved area of the driveline connector unless you intend to disconnect the driveline from the controller. Supplemental labeling information will be provided by the Medtronic field representati

Quantity

82 units

Distribution

Worldwide distribution.

Lot, serial or model codes

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

510(k) numbers

not on file

PMA numbers

not on file

Product code

DSQ

Firm FEI

3007042319

Firm city

Miami Lakes

Firm state

FL

Firm country

not on file

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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