Abiomed recalls Impella 5.5 Smart Assist Set (Pump Set Codes 1000211, 1000212) due to potential introducer sheath leakage. This risk may cause complications during medical procedures. Affected users 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 Impella 5.5 Smart Assist Set (Pump Set Codes 1000211 and 1000212) because of a potential leak in the introducer sheath. This leak could cause complications during medical procedures, but the issue is not visible to users and only affects specific introducer sizes.
The introducer sheath may leak from under the sheath cap and along the hub score lines. This leakage can occur in 14Fr and 23Fr introducers, which are included in every pump set. The issue is not visible to users and only affects specific introducer sizes.
Patients using the Impella 5.5 Smart Assist Set for heart support are most at risk. The recall affects users with Pump Set Codes 1000211 or 1000212.
Check for Pump Set Codes 1000211 or 1000212 on the Impella 5.5 Smart Assist Set. The product includes Introducer Product Code 0052-3006-JP.
Reach out to Abiomed for instructions on how to handle the recalled product.
The recall involves a potential sheath leakage risk, but it is not visible to users and only affects specific introducer sizes. The risk is low.
Contact Abiomed for instructions on how to handle the recalled product.
Check for Pump Set Codes 1000211 or 1000212 on the Impella 5.5 Smart Assist Set. The product includes Introducer Product Code 0052-3006-JP.
We’ve drafted a message you can send Abiomed to request your refund or repair — edit it as you like.
Subject: Recall Z-2687-2026 — Abiomed Abiomed Hello, I own a Abiomed that is covered by recall Z-2687-2026 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.
