# FDA recall Z-0746-2023

> **Heartware, Inc.** · Class II · device recall initiated 2022-11-29.

## Product

HeartWare HVAD Pump Kit, REF 1104

## Reason for recall

Over time, the driveline cover may become hardened, creating difficulty or an inability to slide the cover back to access the driveline to controller connector. Access to the driveline connector may be delayed, which may result in patient harm from a prolonged pump stop, if an urgent driveline connection or controller issue needs to be addressed.  In the event a hardened driveline cover is observed, contact your Medtronic field representative for further assessment and/or servicing.

## Distribution

Worldwide distribution.

## Key facts

- **Recall number:** Z-0746-2023
- **Recalling firm:** Heartware, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2022-11-29
- **Report date:** 2022-12-28

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Miami Lakes, FL, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0746-2023

## Citation

> AI Analytics. FDA recall Z-0746-2023. Retrieved 2026-06-03 from https://api.ai-analytics.org/recall/Z-0746-2023. Source: US FDA. Licensed CC0.

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