- Recalling firm
- Cook Incorporated
- Reason for recall
- Marker bands may be at an increased risk of cracking/breakage. Potential adverse events that may result include increased procedural time, harms associated with device fragmentation/separation, and vessel injury. In a worst-case scenario, device fragmentation and separation may cause life-threatening harm or death.
- Distribution pattern
- US distribution nationwide. OUS distribution to Brunei, Brazil, Canda, China, Colombia, Costa Rica, Hong Kong, Israel, India, Japan, South Korea, Macau, New Zealand, Singapore, El Salvador, Taiwan, Uruguay
- State
- IN
- Status
- Ongoing
- Recall number
- Z-1935-2026
- Recall initiated
- April 2, 2026