Heartware Ventricular Assist System Controller Recall for Loose Connector Ports
Heartware, Inc. is recalling Ventricular Assist System Controllers due to loose connector ports. The recall affects 4,235 units worldwide, including 7,272 in the U.S.
The agency’s classification
FDA (Devices): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The agency classification is FDA Class I, which mandates a minimum severity score of 4 according to the rubric.
Plain-English summary
Heartware, Inc. is recalling the HeartWare Ventricular Assist System Controller because of loose connector ports in the controller body. The device is used as a bridge-to-cardiac transplantation for patients at risk of death from refractory end-stage left ventricular heart failure.
The recall covers 4,235 units worldwide, with 7,272 units in the United States. Distribution includes the U.S. and several international countries. The affected units are all Heartware Controllers manufactured after September 2014, including specific U.S. and international model numbers.
Patients and healthcare providers should contact Heartware, Inc. for instructions on how to address the defect. The source text does not specify a particular action for consumers beyond the recall notice.
The recalled product
- Product
- HeartWare Ventricular Assist System 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 HVAD is designed for in-hospital and out-of-hospital settings…
- Manufacturer
- Heartware, Inc.
- Category
- Medical Device — Cardiac Device
- Hazard
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (4)
- All Heartware Controllers manufactured after September 2014. US Model No: 1400
- 1401XX
- 1403US. International Model No: 1400
- 1407XX.
Distribution
Related recalls
Same manufacturer · Heartware, Inc.
See all →- HighHVAD Ventricular Assist Device Instructions Updated for Controller Alarm and Lifespan
FDA (Devices) · 2023-12-13
- ModerateHeartWare HVAD Implant Kit Instructional Update for Fault Alarms
FDA (Devices) · 2023-12-13
- HighHVAD Ventricular Assist Pump Model 1104CA: Instructions for Fault Alarm and Lifespan
FDA (Devices) · 2023-12-13
- HighMedical Device Instruction Update: HVAD Ventricular Assist Device Clarifications
FDA (Devices) · 2023-12-13
- HighHVAD Ventricular Assist Device Updated Instructions for Alarm Conditions
FDA (Devices) · 2023-12-13
Same hazard · loose connector
See all →- HighRam 1500 driver airbags may not be connected properly
NHTSA · 2025-05-08
- High
- High
Similar recalls
- SevereHeartware Recalls HVAD System Controllers for Exchange
FDA (Devices) · 2017-05-03
- SevereHeartWare Ventricular Assist System Recalled for Power Switching Issues
FDA (Devices) · 2015-07-08
- SevereHeartWare Ventricular Assist System Recalled for Damaged Power Supply Pins
FDA (Devices) · 2015-06-17
- SevereHeartWare HVAD Recall Issued for Internal Controller Alarm Battery Failures
FDA (Devices) · 2015-06-24
- SevereHeartWare Controller Recall Due to Higher Susceptibility to Electrostatic Discharge
FDA (Devices) · 2015-03-04
- SevereHeartware Recalls HVAD System Battery Charger AC Adapters
FDA (Devices) · 2020-03-18