Abiomed recalls Impella CP Set with SmartAssist (10th Generation) containing affected 14Fr Low Profile Introducer Kits due to potential blood clot formation during long-term use. Affected units have specific product codes and batch numbers.
Potential for thrombus formation during prolonged use of the introducer.
Abiomed is recalling its Impella CP Set with SmartAssist (10th Generation) that includes certain 14Fr Low Profile Introducer Kits because they may cause blood clots if used for extended periods. This risk could lead to serious health complications if the device is left in place too long.
The 14Fr Low Profile Introducer Kits in the affected Impella CP Set may form blood clots when used for extended periods. This clotting risk increases the chance of serious complications like stroke or heart attack if the device remains in place longer than recommended.
Patients using the Impella CP Set with SmartAssist for heart support, particularly those with long-term medical needs. Those with the specific product codes and batch numbers listed are most at risk.
Check for product code 1000542, batch number 2041530, or the specific 14Fr Low Profile Introducer Kits 13 and 25 cm Japan. The device was sold in Japan with these identifiers.
Verify your Impella CP Set has product code 1000542 and batch number 2041530.
The recall applies to Impella CP Sets with SmartAssist (10th Generation) containing affected 14Fr Low Profile Introducer Kits 13 and 25 cm Japan with product code 1000542 and batch number 2041530.
The recall does not specify a remedy, so contact Abiomed directly for guidance on next steps.
Check for product code 1000542, batch number 2041530, or the specific 14Fr Low Profile Introducer Kits 13 and 25 cm Japan sold in Japan.
We’ve drafted a message you can send Abiomed to request your refund or repair — edit it as you like.
Subject: Recall Z-2602-2026 — Abiomed Abiomed Hello, I own a Abiomed that is covered by recall Z-2602-2026 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.
