Abiomed recalls Impella 2.5, 5.0, 5.5 and other catheters due to potential left ventricle perforation from improper handling. Affected units include specific product codes and sets. No action needed if device is properly used.
IFU has been updated to include warnings about the risk of the inlet perforating through the myocardial wall of the left ventricle due to operator handling.
Abiomed is recalling several Impella catheters that support circulatory systems. The recall is due to a risk of the device perforating the heart's left ventricle if handled incorrectly by medical professionals. This is a serious hazard that requires immediate attention from healthcare providers using these devices.
The device's inlet can perforate the heart's left ventricle wall if handled incorrectly by medical personnel during use. This risk occurs because the catheter is designed to be inserted into the bloodstream and requires precise handling to avoid damaging the heart tissue.
Healthcare providers using Impella catheters for circulatory support are most at risk. Patients receiving these devices through medical facilities may also be affected if the catheter is handled improperly.
Check for product codes listed in the recall notice: Impella 2.5 (005042), Impella 5.0 (005062), Impella 5.5 (0550-0008), and other specific models with SmartAssist features. The recall includes various pump sets and regional versions.
Check the product codes on your Impella catheter or pump set to confirm if it's affected. The recall includes specific product codes like 005042 for Impella 2.5.
Ensure proper handling procedures are followed as per the updated instructions to avoid potential perforation of the heart's left ventricle.
No. The recall specifically affects Impella 2.5, 5.0, 5.5, and CP models with certain product codes. Right-side devices like Impella RP are not included.
No. The recall requires careful handling as per updated instructions. The device can be used safely if handled correctly.
Check the product code on your device. If it matches the listed codes, follow the updated instructions for safe handling. No return is required as the issue is addressed through 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-0980-2024 — Abiomed Abiomed Hello, I own a Abiomed that is covered by recall Z-0980-2024 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.
