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Class I Recall Notice: Intra-Operative Positioning System Guidewire Issue from Centerline Biomedical
The FDA is aware that Centerline Biomedical has issued a letter to affected customers that the coating on the guidewires for IOPS Guidewire ATW-2, 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.
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.
Questions?
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.
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