Recall Z-1207-2022— Medtronic Inc
Class I · Ongoing
Class I FDA medical device recall by Medtronic Inc, initiated 2022-04-14. FDA's recall record names no specific 510(k) clearance for this event. Product: HeartWare HVAD Pump Implant Kit, a) Model Number 1104JP, b) Model Number MCS1705PU. Reason: The pump may have a welding defect that can lead the pump to malfunction. The issue is under investigation by the firm. It is suspected that a weld defect on the center post cap may allow moisture into the center post and corrode the magnets that keep the impeller rotating concentrically, leading to unintended contact between the center post and impeller. If this occurs, it may affect blood flow through the pump. The issue may present clinical signs and symptoms that resemble pump thrombosis..
- Recalling firm
- Medtronic Inc
- Classification
- Class I
- Status
- Ongoing
- Initiated
- 2022-04-14
- Firm location
- Minneapolis, MN, United States
Product description
HeartWare HVAD Pump Implant Kit, a) Model Number 1104JP, b) Model Number MCS1705PU
Reason for recall
The pump may have a welding defect that can lead the pump to malfunction. The issue is under investigation by the firm. It is suspected that a weld defect on the center post cap may allow moisture into the center post and corrode the magnets that keep the impeller rotating concentrically, leading to unintended contact between the center post and impeller. If this occurs, it may affect blood flow through the pump. The issue may present clinical signs and symptoms that resemble pump thrombosis.
Data sourced from openFDA. This site is unofficial and independent of the FDA.