FDA-Device2022-06-15Class I
HeartWare HVAD Pump Implant Kit, a) Model Number 1104JP, b) Model Number MCS1705PU
Medtronic Inc
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.
Sold states
Worldwide distribution - US Nationwide DE and TX. There was no military/government distribution. The countries of Germany and Japan.
Affected count
21 pump implant kits
Manufactured in
710 Medtronic Pkwy Mailstop Ls245, Minneapolis, MN, United States
Products
HeartWare HVAD Pump Implant Kit, a) Model Number 1104JP, b) Model Number MCS1705PU
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1207-2022Don't want to check this manually?
We email you a Sunday digest of new federal recalls relevant to parents — free, no credit card. Or upgrade to as-it-happens alerts for the brands you actually own.
Get the Sunday Brief