Recall Z-1760-2025 · DQK Computer, Diagnostic, Programmable
Centerline Biomedical Inc
Centerline Biomedical IOPS Guidewire 2, REF ATW-2; Sensorized wire used to navigate through vasculature to facilitate placement of a catheter
| Date | May 19, 2025 (initiated Apr 11, 2025) |
| Status | Open, Classified |
| Reason | Centerline Biomedical has determined that the coating on the guidewires for lot 2404-2005 may delaminate during use of the guidewire. |
| Root cause | Under Investigation by firm |
| Action | Centerline Biomedical issued an "URGENT MEDICAL DEVICE RECALL" notice dated 4/11/2025 to its consignees on 04/11/2025 via hand delivery. The notice explained the issue with the device, potential risk to the patient and actions to be taken. The consignees were requested to Complete the Customer Acknowledgement letter in the possession of your Clinical Account Manager and return all affected products to Clinical Account Manager. For questions contact: Director Quality and Regulatory, Phone Number: (330) 577-5033, Email: kevin.reed@centerlinebiomedical.com. |
| Quantity | 80 units |
| Distribution | US distribution to states of: Pennsylvania, Florida, Texas, New York, North Carolina, New Mexico, Virginia, Tennessee |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K190106 | Intra-Operative Positioning System; Simple Curve Catheter, Reverse Curve Catheter ; Angled Tip Guidewire ; Tracking Pad Centerline Biomedical, Inc., Jun 24, 2019 |
| K230309 | Intra-Operative Positioning System (IOPS®) (MC-1); IOPS Simple Curve Catheter (SCC-1) and IOPS Reverse Curve Catheter (R Centerline Biomedical, Inc., Jun 21, 2023 |
| K241243 | Intra-Operative Positioning System (IOPS®) Viewpoint (Simple Curve Catheters); Intra-Operative Positioning System (IOPS® Centerline Biomedical, Inc., Jul 24, 2024 |
| K242133 | Intra-Operative Positioning System (IOPS®) (Fiducial Tracking Pad); Intra-Operative Positioning System (IOPS®) (Guidewir Centerline Biomedical, Inc., Oct 11, 2024 |
| K243842 | Intra-Operative Positioning System (IOPS®) Centerline Biomedical, Inc., Mar 6, 2025 |