# FDA recall Z-0946-2021

> **Heartware, Inc.** · Class I · device recall initiated 2020-11-19.

## Product

Medtronic HVAD Pump Implant Kits, labeled as:  a. PUMP 1103,   b. PUMP 1104,   c. PUMP 1104JP,  d. PUMP 1100,  e. Model 1101,  f. Model 1102,  g. Model 1104CA-CLIN,  h. Model 1205,  i. Model MCS1705PU

## Reason for recall

Pumps manufactured with impellers from a subset of lots from a single supplier are failing to initially start, restart, or experiencing a delay in restart within the maximum number of restart attempts at a rate substantially higher than pump in the overall population.

## Distribution

Worldwide - US Nationwide

## Key facts

- **Recall number:** Z-0946-2021
- **Recalling firm:** Heartware, Inc.
- **Classification:** Class I
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2020-11-19
- **Report date:** 2021-02-10

- **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-0946-2021

## Citation

> AI Analytics. FDA recall Z-0946-2021. Retrieved 2026-09-03 from https://api.ai-analytics.org/recall/Z-0946-2021. Source: US FDA. Licensed CC0.

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