HeartWare HVAD Pump Kit, REF 1104CA-CLIN
Reported: December 28, 2022 Initiated: November 29, 2022 #Z-0747-2023
Product Description
HeartWare HVAD Pump Kit, REF 1104CA-CLIN
Reason for Recall
Over time, the driveline cover may become hardened, creating difficulty or an inability to slide the cover back to access the driveline to controller connector. Access to the driveline connector may be delayed, which may result in patient harm from a prolonged pump stop, if an urgent driveline connection or controller issue needs to be addressed. In the event a hardened driveline cover is observed, contact your Medtronic field representative for further assessment and/or servicing.
Details
- Recalling Firm
- Heartware, Inc.
- Units Affected
- 6 units
- Distribution
- Worldwide distribution.
- Location
- Miami Lakes, FL
Frequently Asked Questions
What product was recalled? ▼
HeartWare HVAD Pump Kit, REF 1104CA-CLIN. Recalled by Heartware, Inc.. Units affected: 6 units.
Why was this product recalled? ▼
Over time, the driveline cover may become hardened, creating difficulty or an inability to slide the cover back to access the driveline to controller connector. Access to the driveline connector may be delayed, which may result in patient harm from a prolonged pump stop, if an urgent driveline connection or controller issue needs to be addressed. In the event a hardened driveline cover is observed, contact your Medtronic field representative for further assessment and/or servicing.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on December 28, 2022. Severity: Moderate. Recall number: Z-0747-2023.
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