Cook recalls Beacon Tip Centimeter Sizing Catheters with potential marker band cracking. This could cause device fragmentation, vessel injury, or life-threatening harm during angiographic procedures.
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 Beacon Tip Centimeter Sizing Catheters that may have marker bands prone to cracking. This risk could lead to device fragmentation, vessel injury, or life-threatening complications during medical procedures.
The gold marker bands on these catheters may crack or break during use. If the marker band breaks, it could cause the catheter to fragment, potentially leading to vessel injury or life-threatening complications.
Healthcare professionals using these catheters for angiographic procedures. Patients undergoing such procedures are at risk if the catheter cracks during use.
Look for catheters with model numbers NR5.0-35-70-P-10S-0-CSC-20 (G31213), NR5.0-35-100-P-10S-0-CSC-20 (G31214), or similar variants sold by Cook. These are single-use catheters for angiographic procedures.
Identify the model number on the catheter packaging or label to confirm if it matches the recalled variants.
Reach out to Cook Incorporated directly for assistance with the recall process.
The gold marker bands may crack or break during use, potentially causing device fragmentation, vessel injury, or life-threatening harm.
Check the model number to see if it matches the recalled variants. Contact Cook Incorporated for further instructions.
The recall indicates a potential risk of marker band cracking, so it is recommended to check if you have a recalled model before use.
We’ve drafted a message you can send Cook to request your refund or repair — edit it as you like.
Subject: Recall Z-1936-2026 — Cook Cook Hello, I own a Cook that is covered by recall Z-1936-2026 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.
