Recall Z-1760-2025— Centerline Biomedical Inc
Class I · Ongoing
Class I FDA medical device recall by Centerline Biomedical Inc, initiated 2025-04-11. It names 5 FDA 510(k) clearances: K243842, K242133, K241243 and 2 more. Product: Centerline Biomedical IOPS Guidewire 2, REF ATW-2; Sensorized wire used to navigate through vasculature to facilitate placement of a catheter. Reason: Centerline Biomedical has determined that the coating on the guidewires for lot 2404-2005 may delaminate during use of the guidewire..
- Recalling firm
- Centerline Biomedical Inc
- Classification
- Class I
- Status
- Ongoing
- Initiated
- 2025-04-11
- Firm location
- Cleveland, OH, United States
510(k) clearances named in this recall
5 on FDA's record- K243842 — Intra-Operative Positioning System (IOPS®)
- K242133 — Intra-Operative Positioning System (IOPS®) (Fiducial Tracking Pad) +1 more
- K241243 — Intra-Operative Positioning System (IOPS®) Viewpoint (Simple Curve Catheters) +1 more
- K230309 — Intra-Operative Positioning System (IOPS®) (MC-1) +4 more
- K190106 — Intra-Operative Positioning System +4 more
K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.