HeartWare Model 1100 driveline cover hardening may delay urgent access
HeartWare Model 1100 driveline covers may harden over time, making it difficult or impossible to access the driveline-to-controller connector. A delay in accessing the connector during an urgent issue could result in prolonged pump stoppage and patient harm.
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: FDA Class II recall of a risk-of-harm product (critical implantable device) where injury has not yet been reported. The hazard could delay emergency access needed to prevent patient harm, but no actual illnesses or injuries are documented.
Plain-English summary
HeartWare, Inc. is recalling 45 units of the HeartWare Model 1100, an implantable ventricular assist device, due to a driveline cover defect.
Over time, the driveline cover may become hardened, creating difficulty or inability to slide the cover back to access the driveline-to-controller connector. When the cover hardens, accessing the connector may be delayed. A delay in accessing the connector when an urgent driveline connection or controller issue needs to be addressed may result in patient harm from a prolonged pump stop.
The affected devices have been distributed worldwide. Patients and healthcare providers should contact their Medtronic field representative for assessment and servicing if a hardened driveline cover is observed on an affected device. Unless otherwise advised by healthcare providers, continue normal use of the device.
The recalled product
- Product
- HeartWare Model 1100
- Manufacturer
- Heartware, Inc.
- Hazard
- driveline-hardening
- connector-access-delay
- pump-stoppage-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)
- Serial Numbers: HW001
- HW012
- HW016
- HW017
- HW023
- HW025
- HW028
- HW044
- HW045
- HW046
- HW047
- HW049
- HW050
- HW051
- HW061
- HW064
- HW083
- HW084
- HW086
- HW091
Distribution
Distribution scope not specified by the agency.
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