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Early Alert: Sizing Catheter Issue from Cook Medical
The FDA is aware that Cook Medical has issued a letter to affected customers recommending certain sizing catheters be removed from where they are used or sold.
The affected devices are:
- Centimeter Sizing Catheters
- Aurous Centimeter Sizing Catheters
- Beacon Tip Centimeter Sizing Catheters
Cook identified that the marker bands on impacted products may be at an increased risk of cracking/breakage.
Potential adverse events that could result include increased procedural time, harms associated with device fragmentation/separation, and vessel injury. In a worst-case scenario, device fragmentation and separation could cause life-threatening harm or death. As of April 2, Cook has reported no serious injuries and no deaths associated with this issue.
Questions?
Customers in the U.S. with questions about this recall should contact Cook Medical at 812-339-0235.
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