FDA Device Recall Z-0075-2024

Olympus Corporation of the Americas · Center Valley, PA

Class I — life-threatening Ongoing

Highest impact — Class I device recall — FDA determination that use of, or exposure to, the device will cause serious adverse health consequences or death. Distribution is nationwide and the recall remains in progress.

Device

Olympus High-Flow Insufflation Unit, Model UHI-4. For laparoscopic surgery.

Lot / serial / GTIN: UDI-DI: 04953170324147; All Serial Numbers

Quantity: 3136 units

Reason for recall

There have been reports of patients suffering arrhythmias, reported as short cardiac arrests, during surgical procedures where UHI-4s were used. These events may have been due to an over insufflation of the abdominal cavity resulting from use of the UHI-4 during the procedures.

Recall record

Recall number: Z-0075-2024
Classification: Class I
Status: Ongoing
Voluntary or mandated: Voluntary: Firm initiated
Firm notification: Letter
Distribution: US Nationwide distribution.
Recall initiated: 2023-09-22
Classified by FDA Center: 2023-10-18
FDA published: 2023-10-25
Recalling firm: Olympus Corporation of the Americas
Firm location: Center Valley, PA

Operational response

A Class I device recall indicates a strong likelihood of serious adverse health consequence or death from continued use. Identify affected units by serial number, lot, or GTIN against your inventory and against implanted-device patient registry. Pull affected inventory from active use immediately. For implanted devices, follow the recalling firm’s patient-notification protocol; in most cases this requires informing affected patients and their treating physicians directly.

For the official FDA enforcement record, see FDA's Recall Search.

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