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Medtronic Inc recalls HeartWare HVAD Pump Implant Kit, a) Model Number 1104JP, b) Model Number MCS1705PU
Recalled June 15, 2022 · FDA recall Z-1207-2022 · Medtronic
Hazard
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. · FDA Class I
Units
21 pump implant kits
Sold at
Worldwide distribution - US Nationwide DE and TX. There was no military/government distribution. The countries of Germany and Japan.
Description
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.
Product
HeartWare HVAD Pump Implant Kit, a) Model Number 1104JP, b) Model Number MCS1705PU
Manufacturer(s)
Medtronic Inc
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →