Lower risk Medical device recall · FDA · Published February 26, 2021

Heartware HVAD System: Updated Instructions Clarify Controller Connection Beep

Heartware recalls updated instructions for HVAD system to clarify controller connection verification using a beep instead of audible click. This correction helps users identify proper device connection without confusion.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #Z-1438-2021Medical device Heartware ›

Lower-risk recall

IFU and Patient Manual updated to describe HVAD Controller Connection Verification. The labeling is being corrected to reflect the actual verified behavior of a successful connector to the controller, which is a "beep" and not "audible click", to clarify under what alarm conditions a beep will not be heard, and identify alternate confirmation methods (visual indicator) for successful connection. NOTE: this update is included in the February 2021 Urgent Medical Device Notice also covered in recalls 87456 and 87603

Take action

Contact the company

Recalling firmHeartware, Inc.14400 Nw 60th Ave · Miami Lakes, FL 33014-2807

✎ GovInfoNow plain-language explainer

Heartware is recalling the instructions for use and patient manual for their HVAD system to clarify how to verify successful connection to the controller. The update changes the description from an 'audible click' to a 'beep' sound, which helps users avoid misinterpreting connection status and potential device issues. Read more at govinfonow.com/recall/63183-heartware-hvad-system-updated-instructions-clarify-controller-connection-beep.

Source Summary by GovInfoNow · govinfonow.com/recall/63183-heartware-hvad-system-updated-instructions-clarify-controller-connection-beep · Updated August 19, 2026 · FDA enforcement record: FDA #Z-1438-2021

Cite this page

“Heartware HVAD System: Updated Instructions Clarify Controller Connection Beep.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/63183-heartware-hvad-system-updated-instructions-clarify-controller-connection-beep. Based on FDA recall #Z-1438-2021 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1438-2021%22&limit=1).

The Food and Drug Administration announced on Feb. 26, 2021, that Heartware, Inc. recalled Instructions for Use and Patient Manuals for the HeartWare HVAD System to correct labeling regarding controller connection verification. The agency stated the update clarifies that a successful connection produces a beep rather than an audible click.

How to tell if you have it

Heartware HVAD pump implant kits Models 1100, 1101, 1102, 1103, 1104, 1104JP, 1205, and MCS1705PU
Heartware HVAD controller kits Models 1403US, 1407AU, 1407CA, 1407CH, 1407DE, 1407GB, 1407IL, 1407IN, 1407IT, 1407JP, 1407KR, 1420, and 1420JP
Heartware HVAD controller AC adapter Models 1430AR, 1430AU, 1430CA, 1430CH, 1430DE, 1430GB, 1430IL, 1430IN, 1430IT, 1430JP, and 1430US
Heartware HVAD controller DC Adapter Model 1440
Heartware HVAD data cable - monitor Model 1575
Heartware HVAD battery pack Models 1650, 1650CA-CLIN, and 1650DE
Heartware HVAD patient pack Model 1475
Heartware HVAD waist packs Models 2050, 2050IL, and 2050US
Heartware HVAD shoulder packs Models 2060, 2060IL, and 2060US

The hazard

The recall addresses labeling that did not accurately reflect the actual verified behavior of a successful connector to the controller. The updated Instructions for Use and Patient Manual clarify under what alarm conditions a beep will not be heard and identify visual indicators as an alternate confirmation method for successful connection.

Context

GovInfoNow's records show Heartware, Inc. has 17 other recalls on record since Aug. 28, 2018. Other recent recalls of similar products include a pump kit recall regarding hardened driveline covers (Nov. 29, 2022) and a monitor recall involving logfiles not processable by the Autologs Portal (May 16, 2023).

How to tell if you have this one

Check if you own Heartware HVAD pump implant kits (models 1100, 1101, 1102, 1103, 1104, 1104JP, 1205, MCS1705PU) or related controller kits, AC/DC adapters, and accessories listed in the recall notice.

Brand
Heartware
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Review Updated Instructions
Check the updated Instructions for Use and Patient Manual for Heartware HVAD System to confirm the correct connection verification method (beep, not audible click).

Where it went and when

Where it was distributed

Distributed nationwide, and outside the U.S.

FDA distribution: “Worldwide distribution - US Nationwide distribution and the countries of Italy, Great Britain, Germany, Japan.” States read from FDA’s own wording; “not listed” means the notice does not name it.

Distributed nationwide, and outside the U.S.

Recall timeline

FDA published this recall 2 months after the firm started it.

Feb 26, 2021Firm started the recall
Apr 20, 2021FDA classified it Class II
Apr 28, 2021Published in FDA’s Enforcement Report

Dates from the agency record only; steps without a date are left out.

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Link to this recall

<a href="https://govinfonow.com/recall/63183-heartware-hvad-system-updated-instructions-clarify-controller-connection-beep">Heartware HVAD System: Updated Instructions Clarify Controller Connection Beep (GovInfoNow)</a>

Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

Official source: FDA Recall #Z-1438-2021 (February 26, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1438-2021 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.