Abiomed, Inc. 2024-02-21 Health serious FDA
Health · FDA · Recall #FDA-Z-1074-2024
Impella catheters - Intravascular micro axial blood pumps that support a patient's… Recall
Issued February 21, 2024 · Abiomed, Inc.
In February 2024, Abiomed, Inc. recalled the Impella catheters - Intravascular micro axial blood pumps that support a patient's…, a serious health recall reported by the FDA.
Compiled by Maya Ellison, RecallCheckr
What this means for you
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.
What you should do
- 1 Stop using Impella catheters - Intravascular micro axial blood pumps that support a patient's… right away.
- 2 Set it aside where it won't be used by mistake.
- 3 Contact Abiomed, Inc. to arrange your voluntary. See the official notice below for contact details.
- 4 Keep the product until your remedy is fully processed. You may need it.
Official remedy (Voluntary):
Recall details
- Brand
- Abiomed, Inc.
- Category
- Health
- Recall date
- February 21, 2024
- Units affected
- Not reported
- Sold at
- Worldwide distribution - US Nationwide and the countries of AU, CA, DE, FR, IN, MX, TW, and VI.
- Recall number
- FDA-Z-1074-2024
- Made in
- United States
- Issuing agency
- FDA
In context
- Abiomed, Inc. has 9 recalls in our database, including 4 rated Critical.
- We're tracking 3,576 Health recalls in our database.
- This is the 737th Health recall we've logged in 2024.