Cook recalls Aurous Centimeter Sizing Catheters with gold marker bands that may crack, causing vessel injury or death during angiographic procedures. Affected units have specific model numbers and lot codes.
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 Aurous Centimeter Sizing Catheters because their gold marker bands might crack or break during use. This could lead to longer procedures, vessel damage, or even life-threatening harm if the catheter fragments.
The gold marker bands on these catheters may crack or break during use. If the catheter fragments, it could cause vessel injury, prolong procedures, or lead to life-threatening harm in severe cases.
Medical professionals using these catheters for angiographic procedures are most at risk. Patients undergoing such procedures with the recalled catheters could face vessel injury or death.
Check for the model number RPN N5.0-3:5-100-P-10S-PIG-CSC-20-01 or GPN G47308. The catheters were sold with specific lot numbers: 16858459, 16869145, 16857138, 16763324, 16750208, 16752733, 16821053, 16713191.
Immediately stop using the recalled Aurous Centimeter Sizing Catheters if you have them.
The model number is RPN N5.0-35-100-P-10S-PIG-CSC-20-01 or GPN G47308.
Affected lot numbers include 16858459, 16869145, 16857138, 16763324, 16750208, 16752733, 16821053, and 16713191.
The gold marker bands on these catheters may crack or break during use, potentially causing vessel injury or life-threatening harm.
We’ve drafted a message you can send Cook to request your refund or repair — edit it as you like.
Subject: Recall Z-1935-2026 — Cook Cook Hello, I own a Cook that is covered by recall Z-1935-2026 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.
