Lower riskMedical device recall · FDA · Published January 27, 2026
Abiomed Impella RP Flex SmartAssist: Sensor Drift Risk
Abiomed recalls Impella RP Flex with SmartAssist (Product Code 1000323) due to potential sensor drift causing inaccurate readings. Affected units may require monitoring or repair.
“Abiomed Impella RP Flex SmartAssist: Sensor Drift Risk.” GovInfoNow, updated August 17, 2026. https://govinfonow.com/recall/50086-abiomed-impella-rp-flex-smartassist-sensor-drift-risk. Based on FDA recall #Z-1470-2026 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1470-2026%22&limit=1).
Abiomed, Inc. voluntarily recalled Impella RP Flex with SmartAssist devices (Product Code: 1000323) due to a malfunctioning differential pressure sensor that may cause values to drift, the FDA announced on Jan. 27, 2026.
How to tell if you have it
Brand: Abiomed
Product: Impella RP Flex with SmartAssist
Product Code: 1000323
UDI-DI: 00813502012811
The hazard
The differential pressure (dP) sensor in Impella RP devices may malfunction, causing sensor values to drift.
Context
GovInfoNow's records show Abiomed, Inc. has issued 28 other recalls since Sept. 4, 2019. Recent similar recalls include the Abiomed Impella Optical Controller Recall on Aug. 12, 2026, and the Abiomed Impella CP Set Recall on June 11, 2026. Other recent recalls of similar products include the Medline Namic Preceptor Manifold Recall (March 24, 2026) and the Hamilton Medical IntelliCuff Recall (May 22, 2026).
How to tell if you have this one
Check for the product code 1000323 on the device or packaging. The UDI-DI code 00813502012811 is also associated with this recall.
Brand
Abiomed
Category
Medical device
FDA recall event · 3 products
All 3 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.
Classification
Class I
Status
Ongoing
Distribution
Worldwide distribution - US Nationwide and the countries of Austria, Canada, Croatia, Czechia, France, Germany, Hong Kong, Italy, Poland, Serbia, Switzerland.
Recall number
Product, codes & lots
Quantity
Z-1469-2026
Impella RP with SmartAssist. Product Code: 0046-0035.; Product Code: 0046-0035. UDI-DI: 00813502011869.
291 units
Z-1470-2026
Impella RP Flex with SmartAssist. Product Code: 1000323.; Product Code: 1000323. UDI-DI: 00813502012811.
Look for the product code 1000323 or UDI-DI code 00813502012811 on the device or packaging.
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 Austria, Canada, Croatia, Czechia, France, Germany, Hong Kong, Italy, Poland, Serbia, Switzerland.” 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 43 days after the firm started it.
1Firm started the recall
2FDA classified it Class I
3Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
The recall indicates a potential for sensor drift, which could lead to inaccurate readings. However, the device is not immediately dangerous and does not require immediate stop-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-1470-2026 (January 27, 2026) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1470-2026 to see it in context.
Plain-language summary written by qwen3:4b on August 17, 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.