Abiomed recalls 23Fr 11cm Introducer Kits with potential sheath leakage due to manufacturing defects. Affected units may leak under the sheath cap and along hub score lines, but no injuries reported. Consumers should contact Abiomed for details.
A potential for introducer sheath leakage from under the sheath cap and along the hub score lines, identified in 14Fr and 23Fr Introducers. These manufacturing issues are not visually detectable by the user, and 14Fr or 23Fr Introducers are provided in every pump set.
Abiomed is recalling its 23Fr 11cm Introducer Kit pump sets because they may leak from under the sheath cap and along the hub. This leakage could cause infections or other complications during medical procedures. The issue is not visible to users and affects all current batches of the product.
The introducer sheath may leak from under the sheath cap and along the hub score lines due to manufacturing defects. This leakage could lead to infections or other complications during medical procedures. The issue is not visible to users and affects all current batches of the product.
Patients using Abiomed's 23Fr 11cm Introducer Kits with Pump Set Code 1000441 are most at risk. Healthcare providers using these kits for heart pump procedures may also be affected.
Check for the Pump Set Code 1000441 on the product label. The kit includes a 23Fr Introducer, 11cm, Sterile, Introducer. All current batches in the field are affected.
Reach out to Abiomed for specific instructions on how to handle the affected product.
Yes, if your pump set has the code 1000441 and includes a 23Fr 11cm Introducer.
Check for the Pump Set Code 1000441 on the product label. All current batches in the field are affected.
The recall states potential leakage but no injuries have been reported. The risk is considered low.
We’ve drafted a message you can send Abiomed to request your refund or repair — edit it as you like.
Subject: Recall Z-2684-2026 — Abiomed Abiomed Hello, I own a Abiomed that is covered by recall Z-2684-2026 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.
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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.
