# FDA recall Z-1341-2021

> **Heartware, Inc.** · Class I · device recall initiated 2021-02-26.

## Product

Medtronic HVAD Packaged Monitor, Model Numbers:  1500, 1500AU, 1500DE, 1510US, 1511AR, 1511AU, 1511BR, 1511CA, 1511CH, 1511DE, 1511GB, 1511IL, 1511IN, 1511IT, 1511JP, 1511MY, 1520CLIN-AU, 1520CLIN-DE, 1520CLIN-GB, 1520JP, 1520US, 1521AU, 1521BR, 1521CA, 1521CH, 1521DE, 1521GB, 1521IL, 1521IN, 1521IT, 1521JP, 1521KR, 1521TW, 1521US, 1522CA, 1522CA-CLIN

## Reason for recall

There is the potential for the Controller power cables (AC Adapter, DC Adapter, and Battery cables), HVAD Alarm Adapter, and HVAD Monitor data cables to cause damage to the HVAD Controller ports when inserting the cables into the Controller ports, due to wear from misalignment of the cables to the port.

## Distribution

Worldwide

## Key facts

- **Recall number:** Z-1341-2021
- **Recalling firm:** Heartware, Inc.
- **Classification:** Class I
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2021-02-26
- **Report date:** 2021-04-14

- **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-1341-2021

## Citation

> AI Analytics. FDA recall Z-1341-2021. Retrieved 2026-07-01 from https://api.ai-analytics.org/recall/Z-1341-2021. Source: US FDA. Licensed CC0.

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