Lower risk Medical device recall · FDA · Published January 27, 2022

Heartware HVAD System: Updated Cleaning Instructions to Prevent Pin Damage

Heartware recalls specific HVAD system models for updated cleaning instructions to avoid removing lubricant from power connector pins, which could cause power switching issues.

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

🇺🇸 FDA recall #Z-0726-2022Medical device Heartware ›

Lower-risk recall

Updated cleaning instructions are being provided for the Controller AC Adapter, DC Adapter, and Battery to provide clarity to avoid cleaning the power source connector pins, as this could remove the lubricant that is applied to the pins as a mitigation for power switching.

Take action

Contact the company

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

✎ GovInfoNow plain-language explainer

Heartware is recalling certain HVAD systems to update cleaning instructions for the controller adapters and battery. This prevents cleaning the power source connector pins, which could remove lubricant meant to protect against power switching problems. Read more at govinfonow.com/recall/61217-heartware-hvad-system-updated-cleaning-instructions-to-prevent-pin-damage.

Source Summary by GovInfoNow · govinfonow.com/recall/61217-heartware-hvad-system-updated-cleaning-instructions-to-prevent-pin-damage · Updated August 19, 2026 · FDA enforcement record: FDA #Z-0726-2022

Cite this page

“Heartware HVAD System: Updated Cleaning Instructions to Prevent Pin Damage.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/61217-heartware-hvad-system-updated-cleaning-instructions-to-prevent-pin-damage. Based on FDA recall #Z-0726-2022 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0726-2022%22&limit=1).

The FDA announced on Jan. 27, 2022, that Heartware, Inc. is recalling its HeartWare Ventricular Assist Device (HVAD) System due to updated cleaning instructions for power adapters. The agency stated the updates aim to prevent damage to connector pins. This Class II recall affects 197,889 units distributed in the United States and overseas.

How to tell if you have it

Brand: Heartware
Product: HeartWare Ventricular Assist Device (HVAD) System
Model numbers: 1440, 1400, 1401, 1401AU, 1401BR, 1401CA, 1401CH, 1401DE, 1401GB, 1401IL, 1401IN, 1401IT, 1401JP, 1401US, 1403US, 1407AR, 1407AU, 1407BR, 1407CA, 1407CA-CLIN, 1407CH, 1407DE, 1407GB, 1407IL, 1407IN, 1407IT, 1407JP, 1407KR, 1425AU, 1425CA, 1425DE, 1425GB, 1425IL, 1425IT, 1425US, 1430AR, 1430AU, 1430CA, 1430CH, 1430DE, 1430GB, 1430IL, 1430IN, 1430IT, 1430JP, 1430US, 1440, 1650, 1650CA-CLIN, 1650DE
Units affected: 197,889

The hazard

The recall addresses updated cleaning instructions for the Controller AC Adapter, DC Adapter, and Battery. The agency stated that improper cleaning could remove lubricant applied to power source connector pins, which serves as a mitigation for power switching.

Context

GovInfoNow's records show Heartware, Inc. has had 17 other recalls since Aug. 28, 2018. Other recent recalls include the Oct. 31, 2023 update to HVAD Implant Kit instructions clarifying controller faults and the May 16, 2023 recall of monitors with logfiles not processable by the Autologs Portal. A Nov. 29, 2022 recall involved Model 1101 units where hardened driveline covers risked pump stops.

How to tell if you have this one

Check the model numbers on your Heartware HVAD system: 1440, 1400, 1401, 1401AU, 1401BR, 1401CA, 1401CH, 1401DE, 1401GB, 1401IL, 1401IN, 1401IT, 1401JP, 1401US, 1403US, 1407AR, 1407AU, 1407BR, 1407CA, 1407CA-CLIN, 1407CH, 1407DE, 1407GB, 1407IL, 1407IN, 1407IT, 1407JP, 1407KR, 1425AU, 1425CA, 1425DE, 1425GB, 1425IL, 1425IT, 1425US, 1430AR, 1430AU, 1430CA, 1430CH, 1430DE, 1430GB, 1430IL, 1430IN, 1430IT, 1430JP, 1430US, 1440, 1650, 1650CA-CLIN, 1650DE.

Brand
Heartware
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Check Model Numbers
Identify your Heartware HVAD system's model number from the list provided in the recall notice.

Where it went and when

Where it was distributed

Distributed nationwide, and outside the U.S.

FDA distribution: “Distribution throughout the United States. OUS distribution in Argentina, Armenia, Australia, Austria, Belgium, Brazil, Canada, Chile, Colombia, Croatia, Czech Republic, Denmark, Egypt, Estonia, Finland, France, Germany, Greece, Hong Kong,…” 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 48 days after the firm started it.

Jan 27, 2022Firm started the recall
Mar 4, 2022FDA classified it Class II
Mar 16, 2022Published in FDA’s Enforcement Report

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

✎ GovInfoNow

Questions people ask

From the GovInfoNow team · based on the FDA notice · How we make summaries

Is there a risk of serious injury from this recall?

The recall addresses a potential power switching issue, but it is not a risk of serious injury in normal use. The hazard is low risk.

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Link to this recall

<a href="https://govinfonow.com/recall/61217-heartware-hvad-system-updated-cleaning-instructions-to-prevent-pin-damage">Heartware HVAD System: Updated Cleaning Instructions to Prevent Pin Damage (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-0726-2022 (January 27, 2022) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0726-2022 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.