Aurous Centimeter Sizing Catheter Recalled for Marker Band Cracking Risk
Cook Incorporated is recalling Aurous Centimeter Sizing Catheters due to risk of marker band cracking or breakage during angiographic procedures. Potential complications include device fragmentation, vessel injury, and in worst-case scenarios, life-threatening harm or death.
What this means for you
Highest-severity recall. Risk of serious injury or death is documented or strongly suspected. Stop using the product now and follow the agency's instructions.
Our severity reasoning: This is an FDA Class I recall, and the source text explicitly identifies a worst-case scenario involving "life-threatening harm or death." Per the rubric, FDA Class I recalls are never scored below 4, and explicit risk of death triggers a Critical (5) classification.
Plain-English summary
Cook Incorporated is recalling Aurous Centimeter Sizing Catheters (RPN N5.0-35-100-P-10S-PIG-CSC-20-01, GPN G47308) because the gold marker bands on these single-use, sterile catheters are at increased risk of cracking or breakage.
The recalled devices were distributed nationwide in the United States and internationally to Brunei, Brazil, Canada, China, Colombia, Costa Rica, Hong Kong, Israel, India, Japan, South Korea, Macau, New Zealand, Singapore, El Salvador, Taiwan, and Uruguay. A total of 271 units were affected, including Lots 16858459, 16869145, 16857138, 16763324, 16750208, 16752733, 16821053, and 16713191.
If marker bands crack or break during an angiographic procedure, adverse events may include increased procedural time, device fragmentation or separation, and vessel injury. In worst-case scenarios, device fragmentation and separation may cause life-threatening harm or death.
Healthcare providers and patients who have received or used these catheters should contact Cook Incorporated immediately for guidance on the recalled product and potential replacement or corrective actions.
The recalled product
- Product
- Aurous Centimeter Sizing Catheter RPN N5.0-35-100-P-10S-PIG-CSC-20-01 GPN G47308 Sizing catheters are single-use, sterile catheters with gold marker bands. These catheters are for use in angiographic procedures and available in a variety of lengths (70 and 100 cm) and tip co
- Manufacturer
- Cook Incorporated
- Hazard
- device-fracture
- device-separation
- vessel-injury
- life-threatening-harm
Distribution
Distributed nationwide across the United States.