CLASS I Device recall · Reported 4 Mar 2015 · FDA Enforcement Report
Ventricular Assist System (HeartWare Controller) recalled
HeartWare is recalling HeartWare Ventricular Assist System (HeartWare Controller), distributed nationwide in the US. The recall was initiated on 16 Jan 2015 and the FDA has classified it as Class I.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1131-2015
- FDA event ID
- 70340
- Recalling firm
- HeartWare, Miami Lakes, FL
- Classification
- Class I
- Status
- Terminated
- Recall initiated
- 16 Jan 2015
- FDA classified
- 25 Feb 2015
- Reported
- 4 Mar 2015
- Type
- Voluntary: Firm initiated
- Customers notified by
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Reason category
- Device Malfunction
- Device type
- Other Medical Devices
Timeline
| 16 Jan 2015 | Recall initiated by company | |
| 25 Feb 2015 | Classified by FDA | +40 days |
| 4 Mar 2015 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
The affected clinical trial Controllers exhibit a higher susceptibility to ESD than newer commercial Controllers.
Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.
Product as listed by the FDA
HeartWare Ventricular Assist System (HeartWare Controller) Product Usage: For use as a bridge-to-cardiac transplantation in patients who are at risk of death from refractory end-stage left ventricular heart failure. The HeartWare System is designed for in-hospital and out-of-hospital settings, including transportation via fix-wing aircraft or helicopter.
Where it was distributed
Worldwide Distribution - US Nationwide in the states of: AL, AZ, CA, CO, FL, GA, IL, IN, KY, LA, MA, MD, MI, MN, MO, NC, NY, OH, OR, PA, TX, UT, VA, WA and District of Columbia and countries of: Canada, Poland, Australia, Austria, Italy, DE, New Zealand, South Africa, France, Switzerland, Germany, Brazil, UK, Belgium, Netherlands, Israel, Malaysia, Turkey, Greece, Japan, Singapore, Poland, Lithuania, Sweden, Norway, Finland, and India.
Nationwide AlabamaArizonaCaliforniaColoradoDistrict of ColumbiaDelawareFloridaGeorgiaIllinoisIndianaKentuckyLouisianaMassachusettsMarylandMichiganMinnesotaMissouriNorth CarolinaNew YorkOhio
Questions about this recall
Is Ventricular Assist System (HeartWare Controller) recalled?
Yes. HeartWare recalled Ventricular Assist System (HeartWare Controller) on 16 Jan 2015. The recall is Class I and its status is Terminated. Recall number Z-1131-2015.
Why was it recalled?
The affected clinical trial Controllers exhibit a higher susceptibility to ESD than newer commercial Controllers.
Which lots are affected?
Product Codes- US product: Model No.: 1400, 1401US; International product: Model No.: 1400, 1401XX ('XX' represents country designation) Serial No.: CON000001 through CON005472
Where was it sold?
Worldwide Distribution - US Nationwide in the states of: AL, AZ, CA, CO, FL, GA, IL, IN, KY, LA, MA, MD, MI, MN, MO, NC, NY, OH, OR, PA, TX, UT, VA, WA and District of Columbia and countries of: Canada, Poland, Australia, Austria, Italy, DE, New Zealand, South Africa, France, Switzerland, Germany, Brazil, UK, Belgium, Netherlands, Israel, Malaysia, Turkey, Greece, Japan, Singapore, Poland, Lithuania, Sweden, Norway, Finland, and India.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class I mean?
Class I is the most serious FDA recall category: there is a reasonable probability that using the product will cause serious health consequences or death.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from HeartWare
All 69| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | 1104CA-Clin - Hvad (HeartWare Ventricular Assist Device) Pump recalled | Heartware | Device Malfunction | FL |
| Device | CLASS II | Hvad (HeartWare Ventricular Assist Device) Sterile Implant Kit recalled | Heartware | Sterility | FL |
| Device | CLASS II | Sterile Hvad (HeartWare Ventricular Assist Device) Pump (US) recalled | Heartware | Sterility | FL |
| Device | CLASS II | Pump MCS1705PU Hvad (HeartWare Ventricular Assist Device) recalled | Heartware | Device Malfunction | FL |
| Device | CLASS II | Hvad (HeartWare Ventricular Assist Device) Sterile Implant Kit recalled | Heartware | Sterility | FL |
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