The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-0652-2024·Announced 2024-01-17

Abiomed Introducer Kit Sterile Barrier Compromise Due to Pouch Defect

Abiomed Introducer Kits may have holes in outer pouches that compromise sterility, exposing patients to bacterial contamination and risk of infection, bacteremia, or sepsis.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: This is an FDA Class II recall with no reported illnesses or injuries. The hazard—holes in the sterile barrier pouch of a vascular device—creates serious risk of bacterial infection and sepsis, but no adverse events have been reported. This meets the criteria for High severity as a risk-of-harm product where injury has not yet been reported.

Plain-English summary

Abiomed, Inc., is recalling the Abiomed Kit, 14Fr Introducer (Part Number 0052-3046), a component of Impella Catheter systems. Approximately 2,551 units have been distributed in the United States and multiple countries.

Holes in the outer pouches of affected kits may compromise the sterile barrier. Non-sterile introducers expose patients to potential microorganism contamination through the vascular access site, which can lead to infection, bacteremia, or sepsis.

This is an FDA Class II medical device recall. The FDA has assigned recall number Z-0652-2024. Healthcare providers with affected kits should review the FDA recall notice for further information and instructions.

The recalled product

Product
Abiomed Kit, 14Fr Introducer, 13cm&25cm, Sterile Part of Pump Set (0048-0040, 0048-0045, 1000080)-Introducer(s) are intended for introduction of the Impella Catheter into the body. Part Number: 0052-3046
Manufacturer
Abiomed, Inc.
Category
Medical Device — Cardiovascular Device
Hazard
Affected units
2,551

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

  • UDI-DI: N/A

Distribution

Distributed nationwide across the United States.

The notice also names 4 states specifically:

Part of a larger recall action

This product is one of 10 recalled by Abiomed, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 10 products in this recall →

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