HeartWare HVAD Pump Kit recall
HeartWare HVAD Pump Kit, REF 1104JP
Why was HeartWare HVAD Pump Kit 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.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Serial Numbers: HW40657, HW40658, HW40659, HW40660, HW40662, HW40663, HW40664, HW40665, HW40666, HW40667, HW40668, HW40789, HW40816, HW40881, HW40950, HW40951, HW40953, HW40954, HW40956, HW40957, HW40958, HW40960, HW40961, HW41045, HW41047, HW41048, HW41050, HW41214, HW41251, HW41252, HW41254, HW41255, HW41256, HW41258, HW41259, HW41260, HW41262, HW41263, HW41264, HW41265, HW41266, HW41269, HW41270, HW41271, HW41308, HW41309, HW41314, HW41316, HW41317, HW41670, HW41672, HW41673, HW41674, HW41675, HW41699, HW41700, HW41701, HW41783, HW41791, HW41792, HW41803, HW41804, HW41824, HW41828, HW41847, HW41848, HW42285, HW42722, HW42771, HW25169, HW25170, HW25172, HW25174
- Product
- HeartWare HVAD Pump Kit, REF 1104JP
- Recalling firm
- Heartware, Inc.
- Quantity
- 73 units
- Distribution
- Worldwide distribution.
- Recall date
- December 28, 2022
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)