FDA recall Z-1760-2025

Centerline Biomedical Inc · Class I · device

Product

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

Reason for recall

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

Distribution

US distribution to states of: Pennsylvania, Florida, Texas, New York, North Carolina, New Mexico, Virginia, Tennessee

Key facts

Status
Ongoing
Initiation date
2025-04-11
Report date
2025-05-28
Voluntary/Mandated
Voluntary: Firm initiated
Location
Cleveland, OH, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1760-2025