Use cautionMedical device recall · FDA · Published May 18, 2026
Abiomed Impella CP Set with SmartAssist Recall: Low Purge Pressure Alarms
Abiomed recalls Impella CP Set with SmartAssist (product codes 1000080, 1000851, 0048-0014, 0048-0024-JP) due to potential persistent low purge pressure alarms and interruption of mechanical circulatory support.
Exposure to the low purge pressure occurrence may result in persistent low purge pressure alarms and, in some cases, interruption or loss of mechanical circulatory support.
Take action
Contact the company
📍Recalling firmAbiomed, Inc.22 Cherry Hill Dr · Danvers, MA 01923-2575
“Abiomed Impella CP Set with SmartAssist Recall: Low Purge Pressure Alarms.” GovInfoNow, updated August 10, 2026. https://govinfonow.com/recall/49153-abiomed-impella-cp-set-with-smartassist-recall-low-purge-pressure. Based on FDA recall #Z-2457-2026 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2457-2026%22&limit=1).
The FDA announced on May 18, 2026, that Abiomed, Inc. is voluntarily recalling the Impella CP Set with SmartAssist due to a potential exposure to low purge pressure occurrence. This hazard may result in persistent low purge pressure alarms and, in some cases, interruption or loss of mechanical circulatory support.
Exposure to the low purge pressure occurrence may result in persistent low purge pressure alarms and, in some cases, interruption or loss of mechanical circulatory support.
Context
GovInfoNow's records show Abiomed, Inc. has 28 other recalls on record since September 4, 2019. Other recent recalls of similar products include Abiomed Impella Optical Controller Recall (August 12, 2026), Abiomed Impella CP Introducer Kit Recall (June 11, 2026), and Abiomed Impella CP Set Recall (May 22, 2026).
How to tell if you have this one
Check the product codes listed: 1000080, 1000851, 0048-0014, or 0048-0024-JP. The device is used for mechanical circulatory support in heart failure patients.
Brand
Abiomed
Product
Impella CP Set with SmartAssist. Product Codes: 1000080, 1000851, 0048-0014, 0048-0024-JP
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check Product Codes
Verify your Impella CP Set with SmartAssist has one of the product codes: 1000080, 1000851, 0048-0014, or 0048-0024-JP.
Where it went and when
Where it was distributed
Distributed in 7 states, and outside the U.S.
Listed by the agency
Not listed
FDA distribution: “US distribution to GA, IA, NE, PA, TX, WA, WI. International distribution to Czech Republic, Norway, and Japan” States read from FDA’s own wording; “not listed” means the notice does not name it.
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-2457-2026 (May 18, 2026) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2457-2026 to see it in context.
Plain-language summary written by qwen3:4b on August 10, 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.