Heartware HVAD Battery Charger Model 1600US: Wrong Inductors Risk
Heartware recalls HVAD Battery Charger Model 1600US units with wrong inductors. These chargers may not charge batteries properly, risking system failure. Affected units have specific model numbers listed in the recall.
Lower-risk recall
HVAD Battery Charger units manufactured with wrong inductors.
Contact the company
What happened, in plain English
Heartware is recalling HVAD Battery Charger Model 1600US units that were manufactured with incorrect inductors. This could cause the charger to fail to properly charge batteries, potentially leading to system malfunction. Affected units have specific model numbers listed in the recall. Read more at govinfonow.com/recall/69451-heartware-hvad-battery-charger-model-1600us-wrong-inductors-risk.
Source Summary by GovInfoNow · govinfonow.com/recall/69451-heartware-hvad-battery-charger-model-1600us-wrong-inductors-risk · Updated August 20, 2026 · FDA enforcement record: FDA #Z-0582-2019
Cite this page
“Heartware HVAD Battery Charger Model 1600US: Wrong Inductors Risk.” GovInfoNow, updated August 20, 2026. https://govinfonow.com/recall/69451-heartware-hvad-battery-charger-model-1600us-wrong-inductors-risk. Based on FDA recall #Z-0582-2019 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0582-2019%22&limit=1).
Why it’s dangerous
The charger units were manufactured with wrong inductors, which could cause improper battery charging. This might lead to the system not functioning correctly, but it does not pose an immediate risk of serious injury or death.
Who’s affected
Patients using the Heartware Ventricular Assist System (HVAD) with the recalled battery charger model. Those who have the specific model numbers listed in the recall are most at risk.
How to tell if you have this one
Check if your Heartware HVAD Battery Charger has model numbers starting with BCH000403 through BCH098699 (as listed in the recall). These units were manufactured with wrong inductors.
- Brand
Heartware- Category
Medical device
What to do — step by step
Check Model Numbers
Identify your charger's model number to see if it's in the list of affected units (BCH000403 through BCH098699).
Contact Heartware
If your charger is affected, contact Heartware directly for instructions on how to return or replace it.
Where it went and when
Where it was distributed
Distributed nationwide and abroad; the notice names 34 states.
FDA distribution: “Worldwide distribution - US nationwide distribution in the state of AL, AR, AZ, CA, CO, CT, DC, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, NC, NE, NJ, NY, OH, OR, PA, SC, TN, TX, UT, VA, WA, and WI. Countries of Australia,…” States read from FDA’s own wording; “not listed” means the notice does not name it.
Named in the notice: Alabama, Arizona, Arkansas, California, Colorado, Connecticut, District of Columbia, Florida, Georgia, Illinois, Indiana, Iowa, Kansas, Kentucky, Louisiana, Maryland, Massachusetts, Michigan, Minnesota, Mississippi, Missouri, Nebraska, New Jersey, New York, North Carolina, Ohio, Oregon, Pennsylvania, South Carolina, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin.
Recall timeline
FDA terminated this recall 20 months after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
- FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
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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-0582-2019 (November 19, 2018) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0582-2019 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.