# FDA recall Z-2478-2021

> **Heartware, Inc.** · Class II · device recall initiated 2021-08-06.

## Product

Medtronic HVAD Pump Implant Kits

## Reason for recall

There is more force required to slide the driveline cover (boot cover) away from the connector after completion of a Driveline Strain Relief Repair than over an unrepaired strain relief. This may lead to difficulty in pulling back the driveline cover when attempting to access the Driveline connector during a controller exchange. Additionally, sliding the driveline cover over a strain relief repair may compromise the repair.

## Distribution

Distribution throughout the US.    Also distribution in ARGENTINA  Armenia, Australia, Austria, 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, ROMANIA, SAUDI ARABIA, Serbia, Singapore, SLOVAKIA, SOUTH AFRICA,  SPAIN, SWEDEN, SWITZERLAND, Taiwan, TURKEY, Ukraine, United Arab Emirates, United Kingdom, VIETNAM

## Key facts

- **Recall number:** Z-2478-2021
- **Recalling firm:** Heartware, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2021-08-06
- **Report date:** 2021-09-22

- **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-2478-2021

## Citation

> AI Analytics. FDA recall Z-2478-2021. Retrieved 2026-09-03 from https://api.ai-analytics.org/recall/Z-2478-2021. Source: US FDA. Licensed CC0.

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