Centerline Biomedical IOPS Guidewire 2, REF ATW-2; Sensorized wire used to navigate through vasculature to facilitate pl
FDA device recall Z-1760-2025 · posted 2025-05-19 · Open, Classified
Recall details
- Recalling firm
- Centerline Biomedical Inc
- Reason for recall
- Centerline Biomedical has determined that the coating on the guidewires for lot 2404-2005 may delaminate during use of the guidewire.
- Action taken
- 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.
- Root cause
- Under Investigation by firm
- Status
- Open, Classified
- Product code
- DQK
- Quantity affected
- 80 units
- Distribution
- US distribution to states of: Pennsylvania, Florida, Texas, New York, North Carolina, New Mexico, Virginia, Tennessee
- Date initiated
- 2025-04-11
- Date posted
- 2025-05-19
- Location
- Cleveland, OH
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| Intra-Operative Positioning System (IOPS®) (K243842) | Centerline Biomedical, Inc. | 2025-03-06 |
| Intra-Operative Positioning System (IOPS®) (Fiducial Tracking Pad); Intra-Operative Positioning System (IOPS®) (Guidewire Handle) (K242133) | Centerline Biomedical, Inc. | 2024-10-11 |
| Intra-Operative Positioning System (IOPS®) Viewpoint (Simple Curve Catheters); Intra-Operative Positioning System (IOPS®) Viewpoint (Double Curve Catheters) (K241243) | Centerline Biomedical, Inc. | 2024-07-24 |
| Intra-Operative Positioning System (IOPS®) (MC-1); IOPS Simple Curve Catheter (SCC-1) and IOPS Reverse Curve Catheter (RCC-1); IOPS Guidewire (ATW-2); IOPS Tracking Pad (TP-1); IOPS Guidewire Handle (SSH-1) (K230309) | Centerline Biomedical, Inc. | 2023-06-21 |
| Intra-Operative Positioning System; Simple Curve Catheter, Reverse Curve Catheter ; Angled Tip Guidewire ; Tracking Pad ; Guidewire Handle (K190106) | Centerline Biomedical, Inc. | 2019-06-24 |