Intra-Operative Positioning System Guidewire Recall: Centerline Biomedical Removes Certain IOPS Guidewires due to Delamination

This recall involves removing certain devices from where they are used or sold. The FDA has identified this recall as the most serious type. This device may cause serious injury or death if you continue to use it. 

Affected Product 

 

Device Name	Model Number	UDI-DI	Lot   Number
IOPS Guidewire	ATW-2	0084315210203	2404-2005

What to Do 

On April 11, Centerline Biomedical sent all affected customers a letter recommending the following actions:

• Review your inventory to determine if you have any of the affected lots.  
• If you have affected lots, please give them to the Clinical Account Manager. The Clinical Account Manager will replace the affected lots at no cost. 
• Complete the Customer Acknowledgement letter in the possession of your Clinical Account Manager. 

Reason for Recall 

Centerline Biomedical has stated that the coating on the guidewires for lot 2404-2005 may delaminate during use of the guidewire.  

When this issue occurs, there is the possibility that part of the guidewire coating could be left inside of the patient, leading to a retained medical device. Retained medical devices can lead to extended procedure time and/or additional medical procedures to remove the retained medical device. 

There have been no reports of death or serious injury associated with this issue.  

Device Use 

The guidewire is a sensor-equipped wire used with the IOPS system to navigate through vasculature to facilitate placement of a catheter.  

Contact Information

Customers in the U.S. with adverse reactions, quality problems, or questions about this issue should contact Kevin Reed, Quality and Regulatory Director, at 330-577-5033 or at kevin.reed@centerlinebiomedical.com.

Unique Device Identifier (UDI)

The unique device identifier (UDI) helps identify individual medical devices sold in the United States from distribution to use. The UDI allows for more accurate reporting, reviewing, and analyzing of adverse event reports so that devices can be identified more quickly, and as a result, problems potentially resolved more quickly.

• How do I recognize a UDI on a label?
• AccessGUDID database - Identify Your Medical Device
• Benefits of a UDI System

How do I report a problem?

Health care professionals and consumers may report adverse reactions or quality problems they experienced using these devices to MedWatch: The FDA Safety Information and Adverse Event Reporting Program.