# FDA recall Z-1589-2026

> **Abiomed, Inc.** · Class I · device recall initiated 2026-02-18.

## Product

Purge Cassette, sold within Impella Pump Sets and Individually Packaged. Labeled and distributed in the below configurations and corresponding product codes.    1. Purge Cassette, 5 Pack; Product Code: 0043-0003.     2. Impella RP US Pump Set; Product Code: 004334.     3. Purge Cassette, Packaged; Product Code: 0043-0002. Also included inside Product Code 0043-0003 above. Product Code 0043-0002 also includes innermost packaged product with Product Code 0043-0001.    4. Impella 2.5 Set; Product Code: 004413 (Customer facing code 005040).     5. Impella RP Pump Set, EU; Product Code: 0046-0011.     6. Impella CP Pump Set, EU; Product Code: 0048-0002.     7. Impella CP Pump Set BR; Product Code: 0048-0002-BR.     8. Impella CP Smart Assist Set, EU; Product Code: 0048-0014 (Also inclusive of codes 0048-0047 and 1000402 listed below).     9. Impella CP Smart Assist Set, Canada; Product Code: 0048-0044.     10. Impella CP Smart Assist Set APAC; Product Code: 0048-0047 (inclusive under code 0

## Reason for recall

Increased risk of purge leaks with Generation 1 purge cassettes.

## Distribution

Worldwide distribution.

## Key facts

- **Recall number:** Z-1589-2026
- **Recalling firm:** Abiomed, Inc.
- **Classification:** Class I
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2026-02-18
- **Report date:** 2026-04-08

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Danvers, MA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1589-2026

## Citation

> AI Analytics. FDA recall Z-1589-2026. Retrieved 2026-07-17 from https://api.ai-analytics.org/recall/Z-1589-2026. Source: US FDA. Licensed CC0.

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