Lower risk Medical device recall · FDA · Published August 28, 2018

Heartware HVAD System Controller Recall: Water Ingress Risk

Heartware recalls HVAD System Controllers (models 1403, 1407, 1420) due to potential hairline cracks at power ports from water/fluid exposure. Affected units have serial numbers CON300175 to CON320540.

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

🇺🇸 FDA recall #Z-0067-2019Medical device Heartware ›

Lower-risk recall

Certain HVAD System Controller units may not meet the labeled standard for protection against water or fluid ingress, specifically they may have the potential to develop hairline cracks at the power ports of the controller housing.

Take action

Contact the company

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

✎ GovInfoNow plain-language explainer

Heartware is recalling specific HVAD System Controllers (models 1403, 1407, 1420) because they may develop hairline cracks at the power ports when exposed to water or fluids. This could lead to electrical issues or device failure in patients using the system for heart failure treatment. Read more at govinfonow.com/recall/69962-heartware-hvad-system-controller-recall-water-ingress-risk.

Source Summary by GovInfoNow · govinfonow.com/recall/69962-heartware-hvad-system-controller-recall-water-ingress-risk · Updated August 20, 2026 · FDA enforcement record: FDA #Z-0067-2019

Cite this page

“Heartware HVAD System Controller Recall: Water Ingress Risk.” GovInfoNow, updated August 20, 2026. https://govinfonow.com/recall/69962-heartware-hvad-system-controller-recall-water-ingress-risk. Based on FDA recall #Z-0067-2019 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0067-2019%22&limit=1).

Heartware, Inc. recalled Heart Ware(TM) HVAD(TM) System Controller/Controller Kits on Aug. 28, 2018, according to the FDA. The devices may develop hairline cracks at power ports, failing to meet water protection standards. Owners should contact the company for remedy details.

How to tell if you have it

Brand: Heartware
Product: Heart Ware(TM) HVAD(TM) System Controller/Controller Kits
Model Numbers: 1403, 1407, and 1420
Serial number range: CON300175 - CON320540

The hazard

Certain HVAD System Controller units may not meet the labeled standard for protection against water or fluid ingress. Specifically, they may have the potential to develop hairline cracks at the power ports of the controller housing.

Context

GovInfoNow's records show Heartware, Inc. has 17 other recalls on record since 2018-11-19. Other recent recalls include a 2023-10-31 update clarifying controller faults and a 2023-05-16 issue with logfiles not processable by the Autologs Portal. Similar recent recalls of medical devices include a 2026-05-13 HeartMate 3 System Controller recall for backup battery failures and 2025-12-15 Philips Allura Xper FD10C and FD10F recalls for electrical short-circuit risks.

How to tell if you have this one

Check for the model numbers 1403, 1407, or 1420 on the controller. Affected units have serial numbers from CON300175 to CON320540 and are used for heart failure treatment.

Brand
Heartware
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Check Serial Number
Verify the serial number is between CON300175 and CON320540.
Contact Heartware
Reach out to Heartware directly for further instructions on the recall.

How this recall unfolded

Recall timeline

FDA terminated this recall 7 months after the firm started it.

Aug 28, 2018Firm started the recall
Oct 3, 2018FDA classified it Class II
Oct 10, 2018Published in FDA’s Enforcement Report
Apr 5, 2019FDA terminated the recall

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

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Keep exploring

More Heartware recalls

Link to this recall

<a href="https://govinfonow.com/recall/69962-heartware-hvad-system-controller-recall-water-ingress-risk">Heartware HVAD System Controller Recall: Water Ingress Risk (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-0067-2019 (August 28, 2018) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0067-2019 to see it in context.
Plain-language summary written by qwen3:4b on August 20, 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.