# FDA recall Z-2600-2026

> **Abiomed, Inc.** · Class I · device recall initiated 2026-05-22.

## Product

Abiomed 14 Fr x 25 cm Low Profile Introducer Kit for Impella CP. Impella Set Product Code: 1000435. Introducer Product Code: 1000435.

## Reason for recall

Potential for thrombus formation during prolonged use of the introducer.

## Distribution

Worldwide - US Nationwide distribution in the states of FL, IL, MN, NJ, NY, VA and the country of Japan.

## Key facts

- **Recall number:** Z-2600-2026
- **Recalling firm:** Abiomed, Inc.
- **Classification:** Class I
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2026-05-22
- **Report date:** 2026-07-01

- **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-2600-2026

## Citation

> MORVS. FDA recall Z-2600-2026. Retrieved 2026-10-19 from https://api.morvs.ai/recall/Z-2600-2026. Source: US FDA. Licensed CC0.

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*[Dataset catalog](/datasets/) · [FDA recalls dataset](/datasets/fda-recalls) · CC0 1.0*