Abiomed recalls heart pump kits with potential introducer sheath leakage. This risk may cause complications during medical procedures. Affected kits include specific product codes and all current field batches.
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 heart pump kits that may leak from the introducer sheath. This leakage could cause complications during medical procedures, but the issue isn't visible to users. The recall affects all current batches of these kits.
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 isn't visible to users during normal use.
Patients using Abiomed heart pump kits with specific product codes are affected. Those with the 14Fr or 23Fr introducers in the pump set are most at risk.
Check for product codes 0052-0011-JP (pump set) and 0052-3006-JP (introducer). All current batches in the field are affected.
Look for product codes 0052-0011-JP (pump set) and 0052-3006-JP (introducer) on the kit.
No, only kits with specific product codes 0052-0011-JP and 0052-3006-JP are affected.
The leakage isn't visible to users, so you can't tell by inspection. Check the product codes on the kit.
The recall doesn't require stopping use; it's a low-risk issue that needs checking the product codes.
We’ve drafted a message you can send Abiomed to request your refund or repair — edit it as you like.
Subject: Recall Z-2692-2026 — Abiomed Abiomed Hello, I own a Abiomed that is covered by recall Z-2692-2026 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.
