Oscor recalls Abiomed Introducer Kit (REF: 0052-3006) due to potential leakage from 14Fr and 23Fr sheaths. Affected units include specific lots with GTINs 00885672009755 and 00813502011609.
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 has recalled Abiomed's Introducer Kit for Impella Hemostatic Peel Away System (23F model) because of a risk of sheath leakage. This could lead to complications during medical procedures if the kit is used without proper sealing.
The sheaths (14Fr and 23Fr) in the kit could leak fluid from the sidearm, under the sheath cap, and along the hub score lines. This leakage might compromise the device's function during medical procedures, potentially causing complications.
Medical professionals using the Abiomed Introducer Kit for Impella Hemostatic Peel Away System with Infusion Sideport are most at risk. Patients receiving this medical device may also be affected if the kit is used improperly.
Check for the product name 'Introducer Kit for Impella Hemostatic Peel Away Introducer System with Infusion Sideport, 23F' on the packaging. Affected units have specific GTINs: 00885672009755 or 00813502011609.
Verify the product name and GTINs on the packaging to confirm if your unit is affected.
The recall is for potential leakage from the sheaths, which could lead to complications during medical procedures. However, the risk is low and does not cause immediate harm in normal use.
The official recall does not specify a remedy, so check the product details to confirm if it's affected. If affected, contact Oscor for further instructions.
Look for the product name 'Introducer Kit for Impella Hemostatic Peel Away Introducer System with Infusion Sideport, 23F' and check the GTINs: 00885672009755 or 00813502011609.
We’ve drafted a message you can send Oscor to request your refund or repair — edit it as you like.
Subject: Recall Z-2680-2026 — Oscor Oscor Hello, I own a Oscor that is covered by recall Z-2680-2026 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.
