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# Centerline Bio Recalls Catheter Guidewire
- URL: https://www.fdaweb.com/centerline-bio-recalls-catheter-guidewire/
- Published: 2025-05-22T12:00:00.000Z
- Updated: 2026-09-14T15:12:34.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5159228

Centerline Biomedical has recalled (Class 1) its Intra-Operative Positioning System’s (IOPS) Guidewire 2, a sensorized wire used to navigate through a patient’s vasculature to help accurately place a catheter. A [recall notice](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=213421&ref=fdaweb.com) says that the company has determined that the coating on the guidewires for lot# 2404-2005 may delaminate during their use.

The company’s IOPS provides 3D surgical navigation and visualization for endovascular procedures. It uses electromagnetic tracking to determine the position and orientation of sensor-equipped guidewires and catheters to improve endovascular procedure outcomes and mitigate radiation exposure by reducing reliance on traditional X-ray fluoroscopy, according to the company.