Recall Z-1760-2025
Centerline Biomedical Inc · initiated April 11, 2025
Class I – dangerous or defective products that could cause serious health problems or death
Product
Centerline Biomedical IOPS Guidewire 2, REF ATW-2; Sensorized wire used to navigate through vasculature to facilitate placement of a catheter
Codes / lots: UDI/DI 00843152102037, Lot Number 2404-2005
Reason for recall
Centerline Biomedical has determined that the coating on the guidewires for lot 2404-2005 may delaminate during use of the guidewire.
FDA-determined cause: Under Investigation by firm
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.
Details
- Recall number
- Z-1760-2025
- Initiated
- April 11, 2025
- Posted by FDA
- May 19, 2025
- Product code
- DQK – Computer, Diagnostic, Programmable
- Quantity
- 80 units
- Distribution
- US distribution to states of: Pennsylvania, Florida, Texas, New York, North Carolina, New Mexico, Virginia, Tennessee
- Recalling firm
- Centerline Biomedical Inc, Cleveland, OH