Abiomed recalls Impella 5.5 SmartAssist S2 Set (Pump Set Codes 1000459, 1000460) due to potential introducer sheath leakage. This could cause complications during medical procedures.
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 SmartAssist S2 Set (Pump Set Codes 1000459, 1000460) because of a risk of introducer sheath leakage. This leakage could lead to complications during medical procedures, though the issue is not visible to users.
The sheath cap can leak from under the sheath cap and along the hub score lines. This leakage may cause complications during medical procedures, but the issue is not visible to users.
Patients using the Impella 5.5 SmartAssist S2 Set for heart support are most at risk. The recall affects all current batches of the product in use.
Check for Pump Set Codes 1000459 or 1000460 on the Impella 5.5 SmartAssist S2 Set. The product includes Introducer Product Code 0052-3006-JP.
Verify Pump Set Codes 1000459 or 1000460 and Introducer Product Code 0052-3006-JP.
The recall states the issue is not visually detectable, but the product may have a risk of sheath leakage during medical procedures.
Check for Pump Set Codes 1000459 or 1000460 and Introducer Product Code 0052-3006-JP.
The recall does not specify a remedy, so contact Abiomed for guidance.
We’ve drafted a message you can send Abiomed to request your refund or repair — edit it as you like.
Subject: Recall Z-2688-2026 — Abiomed Abiomed Hello, I own a Abiomed that is covered by recall Z-2688-2026 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.
