FDA Device Recall Z-1760-2025

Centerline Biomedical Inc · Cleveland, OH

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.

Device

Centerline Biomedical IOPS Guidewire 2, REF ATW-2; Sensorized wire used to navigate through vasculature to facilitate placement of a catheter

Lot / serial / GTIN: UDI/DI 00843152102037, Lot Number 2404-2005

Quantity: 80 units

Reason for recall

Centerline Biomedical has determined that the coating on the guidewires for lot 2404-2005 may delaminate during use of the guidewire.

Recall record

Recall number: Z-1760-2025
Classification: Class I
Status: Ongoing
Voluntary or mandated: Voluntary: Firm initiated
Firm notification: Visit
Distribution: US distribution to states of: Pennsylvania, Florida, Texas, New York, North Carolina, New Mexico, Virginia, Tennessee
Recall initiated: 2025-04-11
Classified by FDA Center: 2025-05-19
FDA published: 2025-05-28
Recalling firm: Centerline Biomedical Inc
Firm location: Cleveland, OH

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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