There is a potential risk for unintentional interaction of the Impella motor housing with the distal stent of a transcatheter aortic valve replacement (TAVR) resulting in destruction of the impeller blades. This has resulted in low flow from the damaged Impella system. Systemic embolization of the fractured impeller material is a possibility.
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📍Recalling firmAbiomed, Inc.22 &, 24 Cherry Hill Dr · Danvers, MA 01923-2575
✎ GovInfoNow plain-language explainer
Abiomed is recalling Impella LD blood pumps (Product Number 005:0082) because they might interact with a heart valve stent, causing impeller damage that could lead to low blood flow or embolization. This is a serious risk for patients using the device. Read more at govinfonow.com/recall/57846-abiomed-impella-ld-blood-pump-recall-risk-of-impeller-damage.
“Abiomed Impella LD Blood Pump Recall: Risk of Impeller Damage.” GovInfoNow, updated August 18, 2026. https://govinfonow.com/recall/57846-abiomed-impella-ld-blood-pump-recall-risk-of-impeller-damage. Based on FDA recall #Z-2113-2023 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2113-2023%22&limit=1).
The FDA announced on June 14, 2023, that Abiomed, Inc. is recalling Impella LD intravascular micro axial blood pumps due to a potential risk of impeller blade destruction and systemic embolization. The recall affects 9,252 units distributed worldwide.
According to the FDA, there is a potential risk for unintentional interaction of the Impella motor housing with the distal stent of a transcatheter aortic valve replacement (TAVR). This interaction can result in destruction of the impeller blades, causing low flow from the damaged system. Systemic embolization of the fractured impeller material is also a possibility.
Context
GovInfoNow's records show Abiomed, Inc. has 28 other recalls on record since September 4, 2019. Other recent recalls include an Impella Controller purge cassette recognition issue (August 12, 2026), an Impella CP Smart Assist Set introducer sheath leakage risk (June 11, 2026), and an Impella CP Set blood clot risk (May 22, 2026). Other recent recalls of similar products include a Boston Scientific Intera 3000 Hepatic Artery Pump drug leakage risk (May 11, 2026), a Fresenius Kabi Ivenix Infusion Pump downstream occlusion risk (November 3, 2025), and a Fresenius Medical Care 5008X HD/HDF blood tubing set blood leak risk (August 10, 2026).
How to tell if you have this one
Check for the product name 'Impella LD' and Product Number 005082 on the pump's label or documentation. The device was sold with a unique identifier (UDI-DI: 00813502011227).
Brand
Abiomed
Category
Medical device
FDA recall event · 6 products
All 6 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
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-2113-2023 (June 14, 2023) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2113-2023 to see it in context.
Plain-language summary written by qwen3:4b on August 18, 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.