Abiomed recalls Impella RP Flex pump sets with potential introducer sheath leakage. This may cause complications during medical procedures. Affected units include specific pump set codes.
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 certain Impella RP Flex pump sets due to a risk of introducer sheath leakage. This leakage could lead to complications during medical procedures, though the issue isn't visible to users.
The introducer sheath can leak from under the sheath cap and along the hub score lines. This leakage may cause complications during medical procedures, but the issue isn't visible to users.
Medical professionals using the Impella RP Flex pump sets with specific model codes are most at risk. Patients receiving these devices during procedures may also be affected.
Check for pump set code 1000323 on the product label. The affected units include the 23Fr introducer with 11cm length, sterile packaging, and product code 2000342.
Look for pump set code 1000323 and product code 2000342 on the device packaging.
The recall addresses a potential for introducer sheath leakage, which could cause complications during medical procedures. However, the issue is not visible to users and does not pose an immediate risk of serious injury.
Check for pump set code 1000323 and product code 2000342 on the device packaging. Affected units include the 23Fr introducer with 11cm length, sterile packaging.
The recall does not specify a remedy, so contact Abiomed directly for guidance on next steps.
We’ve drafted a message you can send Abiomed to request your refund or repair — edit it as you like.
Subject: Recall Z-2681-2026 — Abiomed Abiomed Hello, I own a Abiomed that is covered by recall Z-2681-2026 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.
