Cook recalls certain Centimeter Sizing Catheters for angiographic procedures due to marker bands that may crack, causing device fragmentation and vessel injury. Affected units include specific model numbers and lots.
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.
Cook is recalling certain Centimeter Sizing Catheters used in angiographic procedures because marker bands may crack or break. This could lead to longer procedures, device separation, or vessel injury. In worst-case scenarios, it might cause life-threatening harm or death.
The marker bands on these catheters can crack or break during use, which may cause the catheter to fragment or separate. This separation could lead to longer procedures, vessel injury, or in worst-case scenarios, life-threatening harm or death.
Healthcare professionals who use these catheters for angiographic procedures are most at risk. Patients undergoing such procedures may be affected if the catheter is used without the recall fix.
Check for the model number RPN N5.0-35-100-P-10S-PIG-CSC-20 and lot numbers listed in the recall (e.g., 16905390, 16905390X). These catheters are used in angiographic procedures and sold by Cook.
Immediately stop using the recalled catheters as they may crack or break, causing device separation and vessel injury.
The affected model is RPN N5.0-35-100-P-10S-PIG-CSC-20 with specific lot numbers listed in the recall.
Check the model number and lot numbers on your catheter against the list provided in the recall notice.
The marker bands may crack or break, leading to device fragmentation, longer procedures, vessel injury, or in worst-case scenarios, life-threatening harm or death.
We’ve drafted a message you can send Cook to request your refund or repair — edit it as you like.
Subject: Recall Z-1934-2026 — Cook Cook Hello, I own a Cook that is covered by recall Z-1934-2026 from Cook. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
