Abiomed recalls 14 Fr x 2:25 cm Low Profile Introducer Kits for Impella CP 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 14 Fr x 25 cm Low Profile Introducer Kit for Impella CP because it may cause blood clots if used for extended periods. This risk is serious for patients needing long-term cardiac support.
The introducer kit can cause blood clots to form in the blood vessels if used for too long. This is a risk during prolonged medical procedures where the device is left in place for extended periods.
Patients using the Impella CP heart pump system with this specific introducer kit are most at risk. Healthcare providers who have this kit in their inventory may also be affected.
Check for product code 1000435 on the kit. The kit was sold with batch numbers 2038707 and 2045782. It is part of the Impella CP system.
Look for product code 1000435 on the kit label or documentation.
Reach out to Abiomed directly for guidance on next steps if you have the affected kit.
The recall states potential for blood clots during prolonged use, so short-term use is not considered a risk.
Check for product code 1000435 and batch numbers 2038707 or 2045782 on the kit.
Contact Abiomed directly for guidance on next steps.
We’ve drafted a message you can send Abiomed to request your refund or repair — edit it as you like.
Subject: Recall Z-2600-2026 — Abiomed Abiomed Hello, I own a Abiomed that is covered by recall Z-2600-2026 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.
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