Abiomed recalls Impella catheters (2.5, 5.0, LD, RP, CP models) due to updated warnings to reduce fiber risk that could cause low blood flow. All affected products have new instructions.
New warnings are being added to the Instructions for Use for all affected products to reduce the possibility of fibers being drawn into the Impella, which may result in low flow of the device.
Abiomed is recalling several Impella catheter models because new warnings are needed to prevent fibers from entering the device, which could lead to reduced blood flow. This is a safety update for medical devices used to support circulation.
The device can draw fibers into its system, which may reduce blood flow. This is a potential issue with the device's internal mechanics during operation, but it's addressed through updated instructions to prevent.
Healthcare providers using Impella catheters for circulatory support are affected. Patients receiving these devices are at risk if the device's blood flow is compromised.
Check for Impella 2.5, 5.0, LD, RP, or CP models with specific product codes listed in the recall notice. All affected products have received an updated Instructions for Use.
Check the product's Instructions for Use for the latest warnings about fiber risks and blood flow.
No, the recall involves updated warnings, not a stop-use order. Continue using the device but follow the new instructions.
All Impella catheters including 2.5, 5.0, LD, RP, and CP models with specific product codes listed in the recall notice.
The recall addresses a potential risk of reduced blood flow, but the hazard is managed through updated instructions. Serious injury is not expected with proper use.
We’ve drafted a message you can send Abiomed to request your refund or repair — edit it as you like.
Subject: Recall Z-1074-2024 — Abiomed Abiomed Hello, I own a Abiomed that is covered by recall Z-1074-2024 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.
