HeartWare Model 1102 Driveline Cover May Harden, Delaying Critical Connector Access
HeartWare Model 1102 cardiac assist devices are being recalled because the driveline cover may harden over time, preventing timely access to the critical driveline connector during urgent clinical situations.
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: Class II medical device with a defect preventing access to critical cardiac connectors during emergencies. Although no hospitalizations have been reported, the potential for serious patient harm from prolonged pump cessation in cardiac patients meets the criterion for high-severity risk-of-harm products.
Plain-English summary
The HeartWare Model 1102 cardiac assist device is being recalled due to potential hardening of the driveline cover over time. This hardening may make the cover difficult or impossible to slide back, preventing access to the driveline-to-controller connector.
Access to the driveline connector is critical for addressing urgent device issues. Delayed access caused by a hardened driveline cover may result in extended pump stoppage and potential patient harm during emergency situations.
The recall affects 892 units distributed worldwide. Patients and healthcare providers using affected devices should contact a Medtronic field representative for assessment and servicing if they observe a hardened driveline cover.
The recalled product
- Product
- HeartWare Model 1102
- Manufacturer
- Heartware, Inc.
- Hazard
- material-hardening
- delayed-access
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: HW951
- HW1000
- HW1001
- HW1002
- HW1003
- HW1006
- HW1007
- HW1008
- HW1010
- HW1011
- HW1013
- HW1017
- HW1018
- HW1019
- HW1026
- HW1027
- HW1029
- HW1030
- HW1034
- HW1035
Distribution
Distribution scope not specified by the agency.
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