HeartWare HVAD Pump Kit driveline cover may harden, impeding urgent access
The driveline cover on HeartWare HVAD Pump Kits may harden over time, preventing access to the driveline to controller connector. This could delay urgent intervention for critical device issues.
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 device recall with no reported illnesses or injuries. The hazard is a life-sustaining device where a manufacturing defect (cover hardening) could prevent urgent access to critical connectors. This meets the rubric criterion for Score 3: risk-of-harm products where injury has not yet been reported.
Plain-English summary
HeartWare, Inc. is recalling the HeartWare HVAD Pump Kit, model REF 1103 (5704 units worldwide distributed). The recalled kits are identified by UDI/DI 00888707003261 and specific serial numbers beginning with HW.
The driveline cover on these pump kits may become hardened over time. When hardened, the cover cannot be easily or at all slid back to access the driveline to controller connector, which is a critical interface for device function and maintenance.
Delayed access to the driveline connector may prevent prompt intervention if a patient requires urgent driveline connection troubleshooting or controller assessment. Since the HVAD is a life-sustaining heart-assist device, any delay in addressing urgent issues could result in patient harm from a prolonged pump stop.
If a hardened driveline cover is observed on your HeartWare HVAD Pump Kit, contact your Medtronic field representative for further assessment and servicing.
The recalled product
- Product
- HeartWare HVAD Pump Kit, REF 1103
- Manufacturer
- Heartware, Inc.
- Hazard
- material-hardening
- access-obstruction
- pump-stop-risk
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)
- UDI/DI 00888707003261
- Serial Numbers: HW11011
- HW11013
- HW11019
- HW11033
- HW11036
- HW11047
- HW11060
- HW11064
- HW11067
- HW11074
- HW11075
- HW11078
- HW11086
- HW11088
- HW11094
- HW11106
- HW11107
- HW11112
- HW11113
Distribution
Distribution scope not specified by the agency.
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