Centerline Recalls Guidewires Over Risk of Coating Detachment

Centerline Biomedical has issued a Class I recall for its IOPS Guidewire ATW-2, used in vascular procedures, due to the risk of the coating detaching and remaining inside patients. While no serious injuries or deaths have been reported, the FDA warns that retained fragments could lead to extended or repeat surgeries, with the potential for serious harm.

The guidewire, used to guide catheters via real-time mapping, may delaminate during use. Centerline issued an urgent recall notice in April, instructing customers to return affected units. The issue is limited to 80 devices distributed across eight U.S. states.

The IOPS system received FDA 510(k) clearance in 2019, with an update cleared in March 2024. This is Centerline’s first FDA-listed recall, placing it among other major medtech companies that have recalled similar devices, though most were classified as lower-risk Class II recalls.

01-07-2025