Abiomed 14 Fr Introducer Kit Recall: Risk of Blood Clots During Prolonged Use

Take action

Contact the company & request your remedy

Recalling firmAbiomed, Inc.22 Cherry Hill Dr, N/A · Danvers, MA 01923-2575

No email on file — write to the address above instead.

✎ GovInfoNow plain-language explainer

What happened, in plain English

Abiomed is recalling its 14 Fr x 13 cm Low Profile Introducer Kit for Impella CP because it may cause blood clots if used for extended periods. This risk is serious enough to require action but does not immediately require stopping use.

Why it’s dangerous

The introducer kit can form blood clots when used for long periods, which may lead to complications like blockages in blood vessels. This risk increases with extended use, especially in medical procedures requiring prolonged device placement.

Who’s affected

Healthcare professionals who use the Abiomed 14 Fr x 13 cm Low Profile Introducer Kit for Impella CP are most at risk. Patients receiving this device for heart support may also be affected.

How to tell if you have this one

Check for the product code 1000434 on the kit. The batch number 2038639 is also associated with this recall. This kit was sold with specific GTIN: 00813502012996.

Brand
Abiomed
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Check Product Details
Verify the product code 1000434 and batch number 2038639 on the kit to confirm it is affected.

✎ GovInfoNow

Questions people ask

Is this recall dangerous?

Yes, the recall is for potential blood clot formation during prolonged use, which could lead to serious complications.

How can I tell if I have the recalled product?

Look for product code 1000434 and batch number 2038639 on the kit. The GTIN is 00813502012996.

Do I need to stop using this product immediately?

No, but you should check the product details to confirm if it is affected and follow the recall instructions.

Take action

Contact Abiomed

We’ve drafted a message you can send Abiomed to request your refund or repair — edit it as you like.

✉️ Open in email

Subject: Recall Z-2599-2026 — Abiomed Abiomed

Hello,

I own a Abiomed that is covered by recall Z-2599-2026 from Abiomed.

I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this?

Thank you.

Similar recalls

From people who’ve dealt with this

Experiences, tips, and questions from readers. Every comment is reviewed before it appears.

No comments yet — be the first to share your experience.

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-2599-2026 (May 22, 2026) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2599-2026 to see it in context.
Plain-language summary written by qwen3:4b on August 10, 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.

Abiomed, Inc. recalls Abiomed 14 Fr x 13 cm Low Profile Introducer Kit for Impella CP. Impella Set Product Code: 1000434. Introducer Product

Use caution until it’s fixed