Cook recalls CrossCath Support Catheters with potential loose or tight radiopaque markers that could affect imaging during procedures. Affected units have specific lot numbers and order numbers.
A manufacturing error may cause the radiopaque marker bands to be too loose on certain CXC3.0 CrossCath Support Catheters (compatible with 0.014 wire guides) and too tight on certain CXC3.4 CrossCath Support Catheters (compatible with 0.018 wire guides).
Cook is recalling certain CrossCath Support Catheters due to a manufacturing error that may cause radiopaque marker bands to be too loose or too tight. This could lead to inaccurate imaging during medical procedures if the catheters are used without proper alignment.
The radiopaque marker bands may be too loose on some catheters (compatible with 0.014 wire guides) or too tight on others (compatible with 0.018 wire guides). This could cause the markers to shift or not align properly during imaging, potentially leading to incorrect placement of the catheter.
Healthcare professionals using the CrossCath Support Catheters for diagnostic and interventional vascular procedures. Patients receiving these catheters are at risk if the markers are misaligned during procedures.
Check for lot numbers 9945301 or 9953512 on the catheter packaging. The product has order number G51583 and UDI codes starting with (01)00827002515833.
Look for lot numbers 9945301 or 9953512 on the catheter packaging.
A manufacturing error may cause the radiopaque marker bands to be too loose on certain CXC3.0 catheters or too tight on certain CXC3.4 catheters, which could affect imaging accuracy during procedures.
The recall record does not specify a remedy, so contact Cook Inc. directly for guidance.
Yes, the affected models are CrossCath Support Catheters with order number G51583 and lot numbers 9945301 or 9953512.
We’ve drafted a message you can send Cook to request your refund or repair — edit it as you like.
Subject: Recall Z-0589-2020 — Cook Cook Hello, I own a Cook that is covered by recall Z-0589-2020 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.
Experiences, tips, and questions from readers. Every comment is reviewed before it appears.
No comments yet — be the first to share your experience.
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.
