Medtronic HeartWare Ventricular Assist HVAD System Battery Charger
Medical device recall Z-0582-2019. Published in FDA’s Enforcement Report on Dec 19, 2018.
No Watch here, and no alerts: openFDA asks that its enforcement data “should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall” (openFDA). For FDA’s own recall emails, subscribe at FDA. FDA’s own record is on accessdata.fda.gov.
The short answer
Published in FDA’s Enforcement Report on Dec 19, 2018. Copied from openFDA on Oct 20, 2026.
- Class II FDA’s class
- Terminated its status, in FDA’s file
- Nationwide FDA’s word, and 35 states named
- 2031 how much, in FDA’s words
Every line below is in FDA’s own words, with its source beside it. FDA’s terms are explained in FDA’s own words.
How serious is it, by FDA’s class?
Class II, the middle of FDA’s three classes.
“Products that might cause a temporary health problem, or pose only a slight threat of a serious nature. Example: a drug that is under-strength but that is not used to treat life-threatening situations.”
openFDA, in plain words, its enforcement report fields.
“Class II is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.”
FDA’s rule, 21 CFR 7.3(m)(2), eCFR.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
What’s wrong with it?
HVAD Battery Charger units manufactured with wrong inductors.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
Medtronic HeartWare Ventricular Assist HVAD System Battery Charger Model 1600US - Product Usage: The HeartWare Ventricular Assist System (HVAD) is indicated in the United States (US) and European Union (EU) for use as a bridge to cardiac transplantation (BTT) as well as an alternative to transplantation as destination therapy (DT) for patients who are at risk of death from refractory end-stage left ventricular heart failure. The HVAD Pump Controller is a microprocessor unit that controls and manages HeartWare System operation. It sends power and operating signals to the blood pump and collects information from the pump. The controller requires two power sources for safe operation: either two batteries, or one battery and an AC adapter or DC adapter. While active, patients will typically use two batteries. While relaxing or sleeping, patients should use power from an electrical outlet (AC adapter) because it provides power for an unlimited period of time. The HeartWare Battery Charger is part of the HeartWare Ventricular Assist System (HVAD). Patients receive 4 total batteries with their system along with a battery charger and are instructed to have spare, fully charged batteries always available. The battery charger can charge up to 4 batteries at a time using 4 charging bays. Each battery slides into a bay and is connected to the battery charger.
2031, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
BCH000403, BCH000405, BCH000406, BCH000415, BCH000420, BCH000422, BCH000423, BCH000426, BCH000428, BCH000433, BCH000435, BCH000440, BCH000442, BCH000446, BCH000451, BCH000456, BCH000459, BCH000464, BCH000465, BCH000470, BCH000471,…
Every code shown here, 1,991 characters
BCH000403, BCH000405, BCH000406, BCH000415, BCH000420, BCH000422, BCH000423, BCH000426, BCH000428, BCH000433, BCH000435, BCH000440, BCH000442, BCH000446, BCH000451, BCH000456, BCH000459, BCH000464, BCH000465, BCH000470, BCH000471, BCH000472, BCH000475, BCH000484, BCH000485, BCH000486, BCH000490, BCH000493, BCH000495, BCH000500, BCH000502, BCH000503, BCH000507, BCH000514, BCH000523, BCH000524, BCH000525, BCH000526, BCH000527, BCH000528, BCH000530, BCH000531, BCH000534, BCH000537, BCH000543, BCH000553, BCH000554, BCH000556, BCH000564, BCH000565, BCH000567, BCH000570, BCH000573, BCH000574, BCH000575, BCH000576, BCH000577, BCH000579, BCH000580, BCH000583, BCH000586, BCH000590, BCH000592, BCH000593, BCH000594, BCH000595, BCH000598, BCH000601, BCH000602, BCH000603, BCH000607, BCH000610, BCH000612, BCH000616, BCH000628, BCH000631, BCH000633, BCH000635, BCH000637, BCH000640, BCH000644, BCH000645, BCH000653, BCH000654, BCH000656, BCH000657, BCH000658, BCH000659, BCH000660, BCH000666, BCH000667, BCH000668, BCH000670, BCH000671, BCH000675, BCH000676, BCH000677, BCH000680, BCH000688, BCH000690, BCH000691, BCH000693, BCH000694, BCH000695, BCH000696, BCH000697, BCH000698, BCH000702, BCH000703, BCH000706, BCH000713, BCH000715, BCH000716, BCH000721, BCH000722, BCH000728, BCH000733, BCH000734, BCH000735, BCH000739, BCH000740, BCH000743, BCH000745, BCH000748, BCH000750, BCH000757, BCH000758, BCH000760, BCH000761, BCH000762, BCH000763, BCH000764, BCH000767, BCH000769, BCH000771, BCH000772, BCH000776, BCH000783, BCH000869, BCH000870, BCH000872, BCH000873, BCH000876, BCH000877, BCH000881, BCH000885, BCH000887, BCH000888, BCH000890, BCH000894, BCH000895, BCH000902, BCH000906, BCH000914, BCH000915, BCH000921, BCH000924, BCH000925, BCH000926, BCH000930, BCH000931, BCH000938, BCH000941, BCH000945, BCH000946, BCH000947, BCH000948, BCH000949, BCH000950, BCH000953, BCH000954, BCH000959, BCH000964, BCH000966, BCH000967, BCH000976, BCH000977, BCH000979, BCH000985, BCH000987, BCH000989,…
FDA’s list runs to 26,739 characters. The first part is shown; the rest is on FDA’s record.
Copied exactly as FDA lists them: lot and serial numbers, dates and other codes on the product or its label.
Where did it go?
FDA’s words for the “general area of initial distribution”: where the firm first shipped it.
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, Austria, Belgium, Canada, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hong Kong, India, Italy, Latvia, Lebanon, Netherlands, Poland, Slovakia, South Africa, Spain, Sweden, Switzerland, Turkey, United Arab Emirates, and United Kingdom.
The states and territories these words name
35 states and territories.
Every one of them
- Alabama
- Arkansas
- Arizona
- California
- Colorado
- Connecticut
- District of Columbia
- Florida
- Georgia
- Iowa
- Illinois
- Indiana
- Kansas
- Kentucky
- Louisiana
- Massachusetts
- Maryland
- Michigan
- Minnesota
- Missouri
- Mississippi
- North Carolina
- Nebraska
- New Jersey
- New York
- Ohio
- Oregon
- Pennsylvania
- South Carolina
- Tennessee
- Texas
- Utah
- Virginia
- Washington
- Wisconsin
What FDA means by nationwide
“The term “nationwide” is defined to mean the fifty states or a significant portion. Note that subsequent distribution by the consignees to other parties may not be included.”
openFDA, its enforcement report fields.
The words say it went outside the United States too.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
Is it still going on?
Terminated, in FDA’s file.
“FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.”
openFDA, on “Terminated”, its enforcement report fields.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
- The firm began the recall on Nov 19, 2018.
- FDA classified it on Dec 7, 2018.
- FDA’s Enforcement Report published it on Dec 19, 2018.
- FDA terminated it on Jul 21, 2020.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Who is recalling it?
- Heartware, Inc., of Miami Lakes, FL.
- Who began it, in FDA’s words: Voluntary: Firm initiated.
- How the firm first told its customers: Letter.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
What this record can’t tell you
- Whether your own one is affected: compare the codes, dates and numbers above with yours. When unsure, ask the firm or the store.
- Where it went after the firm’s first shipments. FDA’s words cover the firm’s initial distribution, and, in FDA’s words, “subsequent distribution by the consignees to other parties may not be included.”
- How many have been returned, corrected or destroyed: FDA’s report doesn’t say.
- Whether anyone was hurt or fell ill: the report doesn’t say.
- How current it is: openFDA publishes FDA’s Enforcement Report weekly, after FDA does, and a firm can announce a recall weeks before it appears there. openFDA’s own caution: “This data should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall.”
- FDA’s list of codes runs to 26,739 characters; the first part is shown here, and the rest is on FDA’s record.
- A product with no recall here isn’t safe by that: FDA’s report lists the recalls FDA classified, and when.
Hearth Record wrote these lines; the quotations are FDA’s.
Sources
-
U.S. Food and Drug Administration, Device recall enforcement reports.
Released Oct 14, 2026 and checked Oct 20, 2026. Updated weekly. Public domain (CC0 1.0, openFDA). FDA asks that nothing suggest it endorses this site.
Recalls of food, medicines, medical devices, pet food and animal drugs are from the U.S. Food and Drug Administration (FDA). FDA does not endorse Hearth Record. openFDA: “Do not rely on openFDA to make decisions regarding medical care.” Copied on Oct 20, 2026.