Use caution Medical device recall · FDA · Published November 7, 2023

Abiomed Introducer Kits Risk Infection Due to Sterile Barrier Compromise

Abiomed recalls 14Fr Introducer Kits with potential sterile barrier holes that could cause infections. Affected kits may expose patients to microorganisms, leading to sepsis or bacteremia. Contact Abiomed for details.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #Z-0652-2024Medical device Abiomed ›

Use caution until it’s fixed

Hole(s) to the outer pouch of the Introducer Kits (both trayed and non-trayed) may compromise the sterile barrier of the Introducer Kits. Non-sterile product exposes patients to the possibility of the introduction of micro-organisms into the vasculature and/or access site, leading to an infectious process, bacteremia or sepsis

Take action

Contact the company

Recalling firmAbiomed, Inc.24 Cherry Hill Dr · Danvers, MA 01923-2575

✎ GovInfoNow plain-language explainer

Abiomed is recalling certain sterile introducer kits that may have holes in their outer pouch, risking infection. This could lead to serious infections like sepsis or bacteremia if the kits are used without a proper sterile barrier. Read more at govinfonow.com/recall/56915-abiomed-introducer-kits-risk-infection-due-to-sterile-barrier-compromise.

Source Summary by GovInfoNow · govinfonow.com/recall/56915-abiomed-introducer-kits-risk-infection-due-to-sterile-barrier-compromise · Updated August 19, 2026 · FDA enforcement record: FDA #Z-0652-2024

Cite this page

“Abiomed Introducer Kits Risk Infection Due to Sterile Barrier Compromise.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/56915-abiomed-introducer-kits-risk-infection-due-to-sterile-barrier-compromise. Based on FDA recall #Z-0652-2024 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0652-2024%22&limit=1).

Abiomed, Inc. recalled Abiomed Kit Introducer Kits due to holes in the outer pouch that may compromise sterility, according to the FDA on 2023-11-07.

How to tell if you have it

Brand: Abiomed
Product: Abiomed Kit, 14Fr Introducer, 13cm&25cm, Sterile Part of Pump Set (0048-0040, 0048-0045, 1000080)
Part Number: 0052-3046
Units affected: 2551

The hazard

Holes to the outer pouch of the Introducer Kits may compromise the sterile barrier. Non-sterile product exposes patients to the possibility of the introduction of micro-organisms into the vasculature and/or access site, leading to an infectious process, bacteremia or sepsis.

Context

GovInfoNow's records show Abiomed, Inc. has had 28 other recalls since 2019-09-04. Recent similar recalls include the Abiomed Impella Controller recall on 2026-08-12 and the Abiomed Impella CP Smart Assist Set Recall on 2026-06-11. Other recent recalls of similar products include the Medline Convenience Kits Recall on 2026-06-12 and the Medline Convenience Kit recall on 2026-07-23.

How to tell if you have this one

Check for part numbers 0048-0040, 0048-0045, or 1000080 on the kit packaging. These kits are used with Impella catheters and are sold for vascular access procedures.

Brand
Abiomed
Category
Medical device

FDA recall event · 10 products

All 10 products in this recall

FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.

Classification
Class II
Status
Ongoing
Distribution
Nationwide Foreign: Country AT AU BE BR CA CA CH CZ DE DK ES FR FR HK IN IT MX MY NL NO PA SG TW UK

Recall number	Product, codes & lots	Quantity
Z-0646-2024	Abiomed Axillary Insertion Introducer -Introducer(s) are intended for introduction of the Impella Catheter into the body. Part Number: 0052-3006 Individual, and Part of Pump Set (005062, 0550-0008, 1000100, 0052-0011, 1000220); UDI-DI: 00885672009755	717 single units; 1906 within sets
Z-0647-2024	Oscor Introducer Kit, 14Fr x Short Individual (0052-0001)- Introducer(s) are intended for introduction of the Impella Catheter into the body. Part Number: 0052-3014; UDI-DI: N/A	4 single units
Z-0648-2024	Abiomed Oscor Introducer Kit, 14Fr x Long Individual (0052-0017)- Introducer(s) are intended for introduction of the Impella Catheter into the body. Part Number: 0052-3015; UDI-DI: N/A	3 single units
Z-0649-2024	Abiomed Introducer Kit, 23 Fr, w/Hlx Vlv Sterile Individual, and Part of Pump Set (004334, 0046-0035, 0052-0002) Part Number: 0052-3021. Intended for introduction of the Impella Catheter into the body; UDI-DI: 00885672009786	193 single units; 1034 units within kits
Z-0650-2024	Abiomed Kit, 14Fr Introducer, 13cm, Long Taper Individual (0052-0038)-Introducer(s) are intended for introduction of the Impella Catheter into the body. Part Number: 0052-3052; UDI-DI: N/A	1784 single units
Z-0651-2024	Abiomed Kit, 14Fr Introducer, 25cm, Long Taper Individual (0052-0039)-Introducer(s) are intended for introduction of the Impella Catheter into the body. Part Number: 0052-0053; UDI-DI: N/A	—
Z-0652-2024	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; UDI-DI: N/A	2551 units within set
Z-0653-2024	Oscor Intro Kit, 14Fr x 13 and 25 cm Part of Pump Set (0048-0040)-Introducer(s) are intended for introduction of the Impella Catheter into the body. Part Number: 0052-3025; UDI-DI: N/A	1 unit within kit
Z-0654-2024	Abiomed KIT, 14 Fr Introducer, 13 & 25 cm, ABMD Part of Pump Set (0048-0024, 0048-0032)-Introducer(s) are intended for introduction of the Impella Catheter into the body. Part Number: 0052-3056; UDI-DI: N/A	2 units within kit
Z-0655-2024	Abiomed Kit, 23Fr Introducer, 11cm, Sterile Part of Pump Set (1000323)-Introducer(s) are intended for introduction of the Impella Catheter into the body. Part Number: 2000342; UDI-DI: N/A	84 units within kits

Based on the official FDA remedy

What to do — step by step

Check Kit Packaging
Look for part numbers 0048-0040, 0048-0045, or 1000080 on the kit packaging to identify affected units.

Where it went and when

Where it was distributed

Distributed nationwide, and outside the U.S.

FDA distribution: “Nationwide Foreign: Country AT AU BE BR CA CA CH CZ DE DK ES FR FR HK IN IT MX MY NL NO PA SG TW UK” States read from FDA’s own wording; “not listed” means the notice does not name it.

Distributed nationwide, and outside the U.S.

Recall timeline

FDA published this recall 2 months after the firm started it.

Nov 7, 2023Firm started the recall
Jan 5, 2024FDA classified it Class II
Jan 17, 2024Published in FDA’s Enforcement Report

Dates from the agency record only; steps without a date are left out.

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Link to this recall

<a href="https://govinfonow.com/recall/56915-abiomed-introducer-kits-risk-infection-due-to-sterile-barrier-compromise">Abiomed Introducer Kits Risk Infection Due to Sterile Barrier Compromise (GovInfoNow)</a>

Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

Official source: FDA Recall #Z-0652-2024 (November 7, 2023) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0652-2024 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.