Critical Alert
Abiomed Recalls Abiomed Impella CP Set with SmartAssist (10th Generation)
This is a Class I recall — the most serious type. There is a reasonable probability of serious health consequences or death.
Source: FDA
CriticalRecall #Z-2601-2026Medical Device
Abiomed Recalls Abiomed Impella CP Set with SmartAssist (10th Generation)
Abiomed, Inc. · Class I — Most Serious
Product Description
Abiomed Impella CP Set with SmartAssist (10th Generation) containing affected 14Fr Low Profile Introducer Kits. Product Codes: 1000413, 1000834.
Reason for Recall
Potential for thrombus formation during prolonged use of the introducer.
FDA Classification
Class I — Most Serious
A situation in which there is a reasonable probability that the use of, or exposure to, a violative product will cause serious adverse health consequences or death.
Distribution
Worldwide - US Nationwide distribution in the states of FL, IL, MN, NJ, NY, VA and the country of Japan.
Remedy
Consumers should stop using this product. Contact the recalling firm for further instructions regarding this product.
411 Press Analysis
A Class I recall — the FDA's most urgent classification — has been issued for a medical device recalled by Abiomed, Inc. on May 22, 2026. Potential for thrombus formation during prolonged use of the introducer. This recall affects 168 units and was distributed internationally, including the United States. Class I recalls indicate a reasonable probability of serious health consequences or death. Consumers should stop using this product immediately.
Sources: FDA openFDA Enforcement Database
This recall appears in: Other Injury Hazards and Abiomed recalls.