Abiomed recalls 10th Gen Impella CP Set with SmartAssist containing affected 14Fr Low Profile Introducer Kits due to potential blood clot formation during long-term use. Product codes and serial numbers listed for identification.
Potential for thrombus formation during prolonged use of the introducer.
Abiomed is recalling its 10th Generation Impella CP Set with SmartAssist that includes certain 14Fr Low Profile Introducer Kits. The recall is because these kits may cause blood clots if used for extended periods.
The 14Fr Low Profile Introducer Kits in the recalled set may form blood clots when used for extended periods. This clotting risk could lead to complications like blockages in blood vessels if not addressed.
Patients using the recalled Impella CP Set with SmartAssist for heart support, particularly those with long-term use of the 14Fr Low Profile Introducer Kits. Medical professionals who have purchased or are using these specific kits are most at risk.
Check for product codes 1000413 or 1000834, and serial numbers listed in the recall notice. The kits were distributed in Japan and include specific batch numbers for identification.
Identify if your Impella CP Set with SmartAssist (10th Generation) has the product codes 1000413 or 1000834 and the listed serial numbers or batch numbers.
The recall is due to potential blood clot formation during prolonged use of the affected 14Fr Low Profile Introducer Kits.
Check for product codes 1000413 or 1000834, and serial numbers or batch numbers listed in the recall notice.
The recall notice does not specify a remedy, so contact Abiomed directly for further instructions.
We’ve drafted a message you can send Abiomed to request your refund or repair — edit it as you like.
Subject: Recall Z-2601-2026 — Abiomed Abiomed Hello, I own a Abiomed that is covered by recall Z-2601-2026 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.
Experiences, tips, and questions from readers. Every comment is reviewed before it appears.
No comments yet — be the first to share your experience.
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.
