Medical Device Instruction Update: HVAD Ventricular Assist Device Clarifications
HeartWare is issuing clarifications to instructions for the PUMP 1103 HVAD ventricular assist device regarding when Controller Fault alarms sound and component useful life. No illnesses or injuries have been reported.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is an FDA Class II recall of a life-critical implantable ventricular assist device. Although no illnesses or injuries have been reported, the issue involves instruction clarity on alarm conditions and component lifespan for a device upon which implant recipients depend for survival, presenting a risk-of-harm scenario. The recall addresses this through instructional updates rather than device replacement.
Plain-English summary
HeartWare, Inc. is recalling the PUMP 1103 HVAD (HeartWare Ventricular Assist Device) IMPLANT KIT, Model Number 1103, with an estimated 7,438 units distributed worldwide. The recall involves issuing updated instructions for use (IFU) and a patient manual to clarify two critical areas: the conditions under which the HVAD Controller Fault alarm may sound and the recommended troubleshooting actions when this alarm occurs.
Additionally, the updates will provide clarified instructions regarding the useful life of HVAD system components. A ventricular assist device is an implantable pump that helps maintain blood circulation for patients with severe heart failure. Unclear instructions about alarm conditions and component lifespan could lead patients and clinicians to misunderstand when intervention or component replacement is necessary, potentially affecting device performance and patient safety.
Patients who have received the PUMP 1103 HVAD implant and their healthcare providers should review the updated instructions and patient manual when received from HeartWare, Inc. No illnesses or injuries have been reported in connection with this recall to date. Patients with questions about the updated instructions should contact their implanting physician or HeartWare, Inc. directly.
The recalled product
- Product
- PUMP 1103 HVAD (HeartWare Ventricular Assist Device) IMPLANT KIT, Model Number 1103
- Manufacturer
- Heartware, Inc.
- Hazard
- instruction-clarity
- alarm-confusion
- component-lifespan
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 (20)
- GTIN none
- Serial Numbers: HW10991
- HW11011
- HW11012
- HW11013
- HW11017
- HW11019
- HW11020
- HW11022
- HW11023
- HW11024
- HW11026
- HW11030
- HW11032
- HW11033
- HW11034
- HW11035
- HW11036
- HW11037
- HW11038
Distribution
Distribution scope not specified by the agency.
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