PlainRecalls
FDA Devices Critical Class I Ongoing

HeartWare HVAD Pump Implant Kit, a) Model Number 1104JP, b) Model Number MCS1705PU

Reported: June 15, 2022 Initiated: April 14, 2022 #Z-1207-2022

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.

Details

Recalling Firm
Medtronic Inc
Units Affected
21 pump implant kits
Distribution
Worldwide distribution - US Nationwide DE and TX. There was no military/government distribution. The countries of Germany and Japan.
Location
Minneapolis, MN

Frequently Asked Questions

What product was recalled? ▼
HeartWare HVAD Pump Implant Kit, a) Model Number 1104JP, b) Model Number MCS1705PU. Recalled by Medtronic Inc. Units affected: 21 pump implant kits.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on June 15, 2022. Severity: Critical. Recall number: Z-1207-2022.

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