# FDA recall Z-1426-2021

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

## Product

Instructions for Use and Patient Manual for HeartWare HVAD System. Accompanies these system components:  HVAD Sterile Implant Kit, Model Numbers:  1100, 1101, 1102, 1103, 1104, 1104JP, 1205, MCS1705PU  HVAD Controller Kit, Model Numbers: 1403US, 1407AU, 1407CA, 1407CH, 1407DE, 1407GB, 1407IL, 1407IN, 1407IT, 1407JP, 1407KR, 1420, 1420JP  HVAD AC Adapter Controller, Model Numbers: 1430AR, 1430AU, 1430CA, 1430CH, 1430DE, 1430GB, 1430IL, 1430IN, 1430IT, 1430JP, 1430US  HVAD DC Adapter Controller: Model Number: 1440  HVAD DATA CABLE 1575- MONITOR, Model Number: 1575  HVAD Battery Pack, Model Numbers: 1650, 1650CA-CLIN, 1650DE  HeartWare Patient Pack, Model Number: 1475  HeartWare Waist Pack, Model Numbers: 2050, 2050IL, 2050OUS  HeartWare Shoulder Pack, Model Numbers: 2060, 2060IL, 2060OUS    The HeartWare HVAD System is indicated for hemodynamic support in patients with advanced, refractory left ventricular heart failure; either as a Bridge to Cardiac Transplantation (BTT), myocardial rec

## Reason for recall

Medtronic HeartWare HVAD System Instructions for Use (IFU) and Patient Manual (PM) updates regarding: Carrying Cases, Driveline Cover Orientation, and Controller Power Up Sequence issues. The PM is being updated to clarify use of the support strap and wear instructions in addition to cleaning instructions of the carrying cases. The IFU and PM are being updated to add a useful life for the carrying cases. The PM is being updated to inform users to keep the driveline cover on when disconnecting and reconnecting the driveline. The IFU and PM are being updated to clarify the power-up sequence that causes the alarm indicator LEDs and both sets of battery LEDs to turn red for 2.5 seconds while the LCD displays the power-on message. NOTE: this update is included in the February 2021 Urgent Medical Device Notice also covered in recalls 87603 and 87604

## Distribution

Worldwide distribution: US (nationwide) and countries of: ARGENTINA, Armenia,  Australia, AUSTRIA, Bahrain, BELGIUM, Brazil, CANADA, Chile, Colombia, Croatia, Czech Republic, Denmark, Egypt, Estonia, FINLAND, France, GERMANY, Greece, Hong Kong, Hungary, INDIA, Israel, Italy, Japan, Kazakhstan, Korea, Kuwait, Latvia, LEBANON, LITHUANIA, Luxembourg, Macedonia, Malaysia, NETHERLANDS, NEW ZEALAND, Norway, POLAND, Qatar, Romania, SAUDI ARABIA, Serbia, Singapore, SLOVAKIA, SOUTH AFRICA  Spain, SWEDEN, SWITZERLAND, Taiwan, TURKEY, Ukraine, United Arab, Emirates, United Kingdom, and VIETNAM.

## Key facts

- **Recall number:** Z-1426-2021
- **Recalling firm:** Heartware, Inc.
- **Classification:** Class I
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2021-02-26
- **Report date:** 2021-04-28

- **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-1426-2021

## Citation

> AI Analytics. FDA recall Z-1426-2021. Retrieved 2026-08-18 from https://api.ai-analytics.org/recall/Z-1426-2021. Source: US FDA. Licensed CC0.

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