---
title: "Abiomed REF: 0052-3025, Introducer Kit for Impella Hemostatic Peel Away Intro... — FDA record Z-2678-2026 | Is It on Recall"
description: "Due to manufacturing issues, there is a potential for the 14Fr and 23Fr introducer sheaths to leak from the sidearm, under the sheath cap, and along the hub sco"
url: https://isitonrecall.com/recall/fda-device-z-2678-2026-abiomed-ref-0052-3025-introducer-kit-for-impella-hemostatic-peel-away-introducer-system-with-infusio/
updated: 2026-10-01
site: "Is It on Recall"
language: en
---

[Recall archive](https://isitonrecall.com/archives/) / FDA device enforcement

# Abiomed REF: 0052-3025, Introducer Kit for Impella Hemostatic Peel Away Introducer System with Infusion Sideport, 14F... — FDA record Z-2678-2026

Reported ongoing

Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.

Source date Jun 10, 2026. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.

Archive changed Oct 1, 2026. USDA FSIS records are unavailable; [check FSIS directly](https://www.fsis.usda.gov/recalls). [Source coverage and dates](https://isitonrecall.com/sources/).

## What the record says

- **Product**: Abiomed REF: 0052-3025, Introducer Kit for Impella Hemostatic Peel Away Introducer System with Infusion Sideport, 14F 13cm and 25cm. heart pump and accessories.
- **Reason**: Due to manufacturing issues, there is a potential for the 14Fr and 23Fr introducer sheaths to leak from the sidearm, under the sheath cap, and along the hub score lines in the hub region.
- **Classification**: Class I
- **Recalling firm**: Oscor Inc.
- **Quantity**: 355 units
- **Agency-reported status**: Ongoing
- **Source record identifier**: Z-2678-2026

[Open the official record](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-2678-2026%22)

[What the recall classes mean](https://isitonrecall.com/guides/recall-classes/). Classification is an agency assessment, not individual medical advice.

## Lot and product identifiers

| Label field | Details supplied by the agency |
| --- | --- |
| Lot, code or applicability | All Lots within Expiry/GTIN:00885672009793, 00813502010664 |

Match all identifying details in the current notice. A brand name alone is not enough.

## Distribution

Distribution in the US state of MA

States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.

- [Massachusetts](https://isitonrecall.com/state/massachusetts/)

## Dates in the source

- **Report date**: Jul 22, 2026
- **Recall initiation date**: Jun 10, 2026
- **Center classification date**: Jul 10, 2026

FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.

## What to do next

Read the official notice for the action that applies to your exact product.

[Read the current instructions](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-2678-2026%22)

## Related records

[Medical devices records](https://isitonrecall.com/category/medical-devices/) [Oscor Inc. records](https://isitonrecall.com/brand/oscor-inc/)