Cook Incorporated: Catheter, Intravascular, Diagnostic
Recall Summary Cook Incorporated is recalling Aurous Centimeter Sizing Catheters used in angiographic procedures because the gold marker bands on these catheters may crack or break during use. If the marker bands break apart, it could prolong the procedure, injure blood vessels, or in severe cases cause life-threatening complications. The affected catheters were distributed nationwide in the U.S. and internationally to multiple countries.
- Recalling firm
- Cook Incorporated
- 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 configurations (straight, PIG, and VCF).
- Reason
- 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.
- Classification
- Class II
- Category
- medical device recall
- Country
- United States
- Agency
- FDA-DEVICES
- Recall date
- 2026-04-02
- Status
- Open, Classified
- Areas affected
- AL, AK, AZ, AR, CA, CO, CT, DE, FL, GA, HI, ID, ...
- Distribution
- US distribution nationwide. OUS distribution to Brunei, Brazil, Canda, China, Colombia, Costa Rica, Hong Kong, Israel, India, Japan, South Korea, Macau, New Zealand, Singapore, El Salvador, Taiwan, Uruguay
Official recall notice from FDA-DEVICES
Recall details on Nibble Recalls: https://trynibble.app/recalls/f2030e24-1a2e-47de-b24c-59f426223577