Critical Alert
Oscor Inc. Recalls Abiomed REF: 0052-3025
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-2678-2026Medical Device
Oscor Inc. Recalls Abiomed REF: 0052-3025
Oscor Inc. · Class I — Most Serious
Product Description
Abiomed REF: 0052-3025, Introducer Kit for Impella Hemostatic Peel Away Introducer System with Infusion Sideport, 14F 13cm and 25cm. heart pump and accessories.
Reason for Recall
Due to manufacturing issues, there is a potential for the 14Fr and 23Fr introducer sheaths to leak from the sidearm, under the sheath cap, and along the hub score lines in the hub region.
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
Distribution in the US state of MA
Remedy
Consumers should stop using this product. Contact the recalling firm for further instructions regarding this product.
411 Press Analysis
The FDA has classified this as a Class I recall — the most serious classification reserved for situations where there is a reasonable probability that use of, or exposure to, the product will cause serious adverse health consequences or death. Oscor Inc. initiated this recall of medical device on June 10, 2026 affecting 355 units. Due to manufacturing issues, there is a potential for the 14Fr and 23Fr introducer sheaths to leak from the sidearm, under the sheath cap, and along the hub score lines in the hub region. The product was distributed in Distribution in the US state of MA. Consumers who have this product should stop using it immediately and contact the recalling firm.
Sources: FDA openFDA Enforcement Database
This recall appears in: Other Injury Hazards.