Centerline Biomedical IOPS Guidewire 2, REF ATW-2 recallZ-1760-2025 · Centerline Biomedical Inc · initiated Apr 11, 2025
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Centerline Biomedical Inc or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Centerline Biomedical has determined that the coating on the guidewires for lot 2404-2005 may delaminate during use of the guidewire.
FDA root cause category: Under Investigation by firm
What the company is doing
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: [email protected].
Recall details
- Recall number
- Z-1760-2025
- Status
- Open, Classified
- Initiated by the company
- Apr 11, 2025
- Posted by the FDA
- May 19, 2025
- Recalling firm
- Centerline Biomedical Inc
- Quantity
- 80 units
- Product code
- DQK
- FDA submissions
- K190106, K230309, K241243, K242133, K243842
- Distribution
- US distribution to states of: Pennsylvania, Florida, Texas, New York, North Carolina, New Mexico, Virginia, Tennessee
Product description
Centerline Biomedical IOPS Guidewire 2, REF ATW-2; Sensorized wire used to navigate through vasculature to facilitate placement of a catheter
Code information (models, lots, serial numbers)
UDI/DI 00843152102037, Lot Number 2404-2005
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- IOPS™ ATW-2Centerline Biomedical, Inc. · Computer, Diagnostic, Programmable1 recall3 reports
Other devices under the same FDA submission
1 device cleared under K190106, K230309, K241243, K242133, K243842 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.
- IOPS Mobile Cart MC-1Centerline Biomedical, Inc. · Computer, Diagnostic, Programmable1 report
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
How recalls are matched to devices · Editorial policy · Report an error on this page