Abiomed recalls Impella CP Set (Code 0048-0003) due to potential introducer sheath leakage. This risk may cause complications during heart pump procedures. Affected units include specific model sizes.
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 CP Set (Pump Set Code 0048-0003) because manufacturing issues could cause sheath leakage in the introducer. This leakage might lead to complications during heart pump procedures, though it's not immediately dangerous.
The introducer sheath can leak fluid from under the sheath cap and along the hub score lines due to manufacturing defects. This leakage may cause complications during heart pump procedures, but it's not immediately life-threatening.
Patients using the Impella CP heart pump system for cardiac support are most at risk. The recall affects specific model sizes (14Fr and 23Fr) included in the pump set.
Check for the pump set code 0048-0003 or introducer product code 0052-3046. The affected units include 14Fr (13 cm and 25 cm) introducers.
Look for pump set code 0048-0003 or introducer product code 0052-3046 on the packaging.
The recall is for potential sheath leakage during heart pump procedures, but it's not immediately life-threatening. The risk is low and requires medical attention if issues arise.
The official recall record does not specify a remedy or action steps. Check the product codes to confirm if you have the affected units.
Affected units include the Impella CP Set with pump set code 0048-0003 and introducer product code 0052-3046, specifically 14Fr (13 cm and 25 cm) introducers.
We’ve drafted a message you can send Abiomed to request your refund or repair — edit it as you like.
Subject: Recall Z-2682-2026 — Abiomed Abiomed Hello, I own a Abiomed that is covered by recall Z-2682-2026 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.
