# FDA recall Z-1207-2022

> **Medtronic Inc** · Class I · device recall initiated 2022-04-14.

## Product

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.

## Distribution

Worldwide distribution - US Nationwide DE and TX. There was no military/government distribution. The countries of Germany and Japan.

## Key facts

- **Recall number:** Z-1207-2022
- **Recalling firm:** Medtronic Inc
- **Classification:** Class I
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2022-04-14
- **Report date:** 2022-06-15

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Minneapolis, MN, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1207-2022

## Citation

> AI Analytics. FDA recall Z-1207-2022. Retrieved 2026-06-25 from https://api.ai-analytics.org/recall/Z-1207-2022. Source: US FDA. Licensed CC0.

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