# FDA recall Z-2128-2023

> **Abiomed, Inc.** · Class II · device recall initiated 2023-05-26.

## Product

Abiomed 14Fr Low Profile Introducer Set, Product Number 1000457

## Reason for recall

There was one complaint that the sidearm of the device detached during explant of a pump.  When the sidearms are subjected to heat, humidity and articulation, a silicone oil contaminant that was unintentionally introduced during manufacturing at the joint between the sidearm and the hub may cause the joint to detach.

## Distribution

US Nationwide distribution in the states  of MN, NJ, TN.

## Key facts

- **Recall number:** Z-2128-2023
- **Recalling firm:** Abiomed, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2023-05-26
- **Report date:** 2023-07-19

- **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-2128-2023

## Citation

> AI Analytics. FDA recall Z-2128-2023. Retrieved 2026-07-17 from https://api.ai-analytics.org/recall/Z-2128-2023. Source: US FDA. Licensed CC0.

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