Lower riskMedical device recall · FDA · Published December 27, 2023
Abiomed Impella catheters: New warnings to prevent blood flow issues
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.
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Contact the company
📍Recalling firmAbiomed, Inc.24 Cherry Hill Dr · Danvers, MA 01923-2575
“Abiomed Impella catheters: New warnings to prevent blood flow issues.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/56464-abiomed-impella-catheters-new-warnings-to-prevent-blood-flow-issues. Based on FDA recall #Z-1074-2024 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1074-2024%22&limit=1).
The FDA announced on Dec. 27, 2023, that Abiomed, Inc. is recalling Impella catheters to add new warnings about fiber draw-in risks. The agency issued recall number Z-1074-2024 for the intravascular micro axial blood pumps.
Distribution: Worldwide (US Nationwide; AU, CA, DE, FR, IN, MX, TW, VI)
The hazard
The recall addresses the possibility of fibers being drawn into the Impella device, which may result in low flow. The FDA stated that new warnings are being added to the Instructions for Use for all affected products to mitigate this risk.
Context
GovInfoNow's records show Abiomed, Inc. has 28 other recalls on record since 2019-09-04. Other recent recalls of similar products include Abiomed Impella Controller: Purge Cassette Recognition Issues (2026-08-12), Abiomed Impella CP Smart Assist Set Recall: Introducer Sheath Leakage Risk (2026-06-11), and Abiomed Impella CP Set Recall: Risk of Blood Clots During Prolonged Use (2026-05-22). Other recent recalls of similar products include Merit Medical ProGuide Dialysis Catheters Recall: Risk of Bleeding and Blockage (2026-02-13), Merit Medical BioFlo DuraMax Catheter Recall: Design Defect May Cause Bleeding (2026-02-13), and Medline ViewFlex Xtra ICE Catheters Recall: Risk of Infection from Reprocessed Catheters (2025-12-22).
How to tell if you have this one
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.
Brand
Abiomed
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Review Updated Instructions
Check the product's Instructions for Use for the latest warnings about fiber risks and blood flow.
Where it went and when
Where it was distributed
Distributed nationwide, and outside the U.S.
Nationwide
Not listed
FDA distribution: “Worldwide distribution - US Nationwide and the countries of AU, CA, DE, FR, IN, MX, TW, and VI.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide, and outside the U.S.
Recall timeline
FDA published this recall 56 days after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
No, the recall involves updated warnings, not a stop-use order. Continue using the device but follow the new instructions.
Is there a risk of serious injury?
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.
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.
Official source: FDA Recall #Z-1074-2024 (December 27, 2023) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1074-2024 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.