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

Heartware Medtronic HVAD Controller Recall: Cable Misalignment Risk

Heartware recalls Medtronic HVAD Controller models 1400-1407 with potential port damage from cable misalignment. Affected users should contact Heartware for details.

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

🇺🇸 FDA recall #Z-1336-2021Medical device Heartware ›

Lower-risk recall

There is the potential for the Controller power cables (AC Adapter, DC Adapter, and Battery cables), HVAD Alarm Adapter, and HVAD Monitor data cables to cause damage to the HVAD Controller ports when inserting the cables into the Controller ports, due to wear from misalignment of the cables to the port.

Take action

Contact the company

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

✎ GovInfoNow plain-language explainer

Heartware is recalling Medtronic HVAD Controllers with specific product numbers due to a risk that cables can damage the controller ports when inserted incorrectly. This could lead to device malfunction or failure if the cables are misaligned. Read more at govinfonow.com/recall/63189-heartware-medtronic-hvad-controller-recall-cable-misalignment-risk.

Source Summary by GovInfoNow · govinfonow.com/recall/63189-heartware-medtronic-hvad-controller-recall-cable-misalignment-risk · Updated August 19, 2026 · FDA enforcement record: FDA #Z-1336-2021

Cite this page

“Heartware Medtronic HVAD Controller Recall: Cable Misalignment Risk.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/63189-heartware-medtronic-hvad-controller-recall-cable-misalignment-risk. Based on FDA recall #Z-1336-2021 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1336-2021%22&limit=1).

The FDA announced on Feb. 26, 2021, that Heartware, Inc. is recalling Medtronic HVAD Controllers due to the potential for power and data cables to damage controller ports from misalignment. This voluntary Class I recall affects 56,018 units distributed worldwide.

How to tell if you have it

Brand: Heartware
Product: Medtronic HVAD Controller
Product Numbers: 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
Lot Codes: All lot codes

The hazard

According to the FDA, there is a potential for the Controller power cables (AC Adapter, DC Adapter, and Battery cables), HVAD Alarm Adapter, and HVAD Monitor data cables to cause damage to the HVAD Controller ports when inserting the cables into the Controller ports. This damage results from wear caused by misalignment of the cables to the port.

Context

GovInfoNow's records show Heartware, Inc. has had 17 other recalls on record since Aug. 28, 2018. Recent updates include a Oct. 31, 2023 recall for the Heartware HVAD Sterile Implant Kit Model 1100 to clarify alarm conditions, and a May 16, 2023 recall regarding logfiles not processable by the Autologs Portal. Other recent recalls of similar products include the HeartMate 3 System Controller Recall for backup battery failures risk (May 13, 2026), the Medtronic Octopus Nuvo Tissue Stabilizer Recall for incorrect tube assembly (Jan. 13, 2026), and the AVID Medical Halyard CARDIAC CATH PACK SAN23CARDQ Kit Recall for risk of loose connections (March 13, 2026).

How to tell if you have this one

Check your Medtronic HVAD Controller for product numbers starting with 1400, 1401, 1401AU, 1401BR, 1401CA, 1401CH, 1401DE, 1401GB, 1401IL, 1401IN, or similar numbers listed in the recall notice.

Brand
Heartware
Category
Medical device

FDA recall event · 6 products

All 6 products in this recall

FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.

Classification
Class I
Status
Ongoing
Distribution
Worldwide

Recall number	Product, codes & lots	Quantity
Z-1336-2021	Medtronic HVAD Controller, Product Numbers: 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; All lot codes	56,018 units (28,449 US)
Z-1337-2021	Power Supply: 1. Medtronic HVAD Controller AC Adapter, Product Numbers: 1425AU, 1425CA, 1425DE, 1425GB, 1425IL, 1425IT, 1425US, 1430AR, 1430AU, 1430CA, 1430CH, 1430DE, 1430GB, 1430IL, 1430IN, 1430IT, 1430JP, 1430US 2. Medtronic HVAD Controller DC Adapter, Product Number: 1440; All lot codes	17992 units (8054 US)
Z-1338-2021	Medtronic HVAD Alarm Adapter, Product Number: 1450; All lot codes	418 units (315 US)
Z-1339-2021	Medtronic HVAD Monitor Data Cable, Product Number: 1575; All lot codes	1337 units (1110 US)
Z-1340-2021	Medtronic HVAD Battery, Product Number: 1650, 1650CA-CLIN, 1650DE; All lot codes	114,133 devices (66,613 US)
Z-1341-2021	Medtronic HVAD Packaged Monitor, Model Numbers: 1500, 1500AU, 1500DE, 1510US, 1511AR, 1511AU, 1511BR, 1511CA, 1511CH, 1511DE, 1511GB, 1511IL, 1511IN, 1511IT, 1511JP, 1511MY, 1520CLIN-AU, 1520CLIN-DE, 1520CLIN-GB, 1520JP, 1520US, 1521AU, 1521BR, 1521CA, 1521CH, 1521DE, 1521GB, 1521IL, 1521IN, 1521IT, 1521JP, 1521KR, 1521TW, 1521US, 1522CA, 1522CA-CLIN; All lot codes	3283 devices (1824 US)

Based on the official FDA remedy

What to do — step by step

Check Product Numbers
Identify your Medtronic HVAD Controller's product number to see if it matches the recalled list.

How this recall unfolded

Recall timeline

FDA published this recall 47 days after the firm started it.

Feb 26, 2021Firm started the recall
Apr 6, 2021FDA classified it Class I
Apr 14, 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/63189-heartware-medtronic-hvad-controller-recall-cable-misalignment-risk">Heartware Medtronic HVAD Controller Recall: Cable Misalignment 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-1336-2021 (February 26, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1336-2021 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.