Oscor recalls Abiomed Introducer Kits (14F/23F) due to potential sheath leaks. This could cause bleeding or infection during heart pump procedures. Affected units have specific GTINs and expiry dates.
Due to manufacturing issues, there is a potential for the 14Fr and 23Fr introducer sheaths to leak from the sidearm, under the sheath cap, and along the hub score lines in the hub region.
Oscor is recalling Abiomed Introducer Kits for heart pumps because they might leak blood or fluid from the sheaths. This could lead to bleeding or infection during medical procedures. If you have the recalled kit, stop using it immediately.
The sheaths can leak blood or fluid from the sidearm, under the cap, and along the hub. This leakage could cause bleeding or infection during critical medical procedures like heart pump surgeries.
Medical professionals using the Abiomed Introducer Kit for heart pump procedures are most at risk. Patients receiving these kits during surgery may also be affected.
Check for the Abiomed Introducer Kit with model numbers 14F or 23F. The product has GTINs 00885672009786 or 00813502010558 and was sold before the expiry date.
Immediately stop using the Abiomed Introducer Kit if you have it. The leaking sheaths could cause serious bleeding or infection during medical procedures.
The recalled kit is the Abiomed Introducer Kit for Impella Hemostatic Peel Away Introducer System with Infusion Sideport, 14F or 23F.
Check the GTINs: 00885672009786 or 00813502010558. The kit was sold with an expiry date before the product's current date.
The recall record does not mention any remedy or fix for the leaking sheaths.
We’ve drafted a message you can send Oscor to request your refund or repair — edit it as you like.
Subject: Recall Z-2679-2026 — Oscor Oscor Hello, I own a Oscor that is covered by recall Z-2679-2026 from Oscor. 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.
