HeartWare Model 1101 Implant: Hardened Driveline Cover May Delay Connector Access
The driveline cover on some HeartWare Model 1101 implanted pumps may harden over time, making it difficult to access the driveline connector. This could delay urgent maintenance, potentially causing 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: This is a Class II medical device recall for an implantable cardiac pump where a component may harden, delaying access to critical connectors needed for urgent maintenance. No illnesses or injuries have been reported, but the potential consequence of delayed pump access—prolonged pump stoppage causing patient harm—qualifies this as a risk-of-harm product where injury has not yet been reported.
Plain-English summary
HeartWare, Inc. is recalling the HeartWare Model 1101 implantable left ventricular assist device. The FDA has identified that the driveline cover on affected units may become hardened over time.
As the driveline cover hardens, it becomes difficult or impossible to slide back to access the driveline to controller connector. When urgent maintenance or troubleshooting is needed, delayed access to this connector may result in prolonged pump stoppage and patient harm.
The recall affects 82 units with specific serial numbers distributed worldwide. If you are using a HeartWare Model 1101 and observe a hardened driveline cover, contact your Medtronic field representative for further assessment and servicing.
The recalled product
- Product
- HeartWare Model 1101
- Manufacturer
- Heartware, Inc.
- Hazard
- component-hardening
- delayed-access
- 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: HW1146
- HW1205
- HW1209
- HW1247
- HW1454
- HW1533
- HW1634
- HW1688
- HW1951
- HW200
- HW281
- HW378
- HW383
- HW469
- HW492
- HW557
- HW816
- HW933
- HW1091
- HW1143
Distribution
Distribution scope not specified by the agency.
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