Beacon Tip Centimeter Sizing Catheter recalled for cracking marker bands
Cook Incorporated is recalling Beacon Tip Centimeter Sizing Catheters because marker bands may crack or break, which could lead to device fragmentation, prolonged procedures, vessel injury, and in worst-case scenarios, life-threatening harm or death.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The FDA classified this as Class I, which per the rubric requires a minimum score of 4. The source text explicitly describes worst-case scenarios of life-threatening harm or death, and the hazard involves a medical device used in invasive cardiovascular procedures with potential for vessel injury.
Plain-English summary
Cook Incorporated is recalling Beacon Tip Centimeter Sizing Catheters (model numbers G31213, G31214, G31216, G31220, and G31221) because the marker bands may be at increased risk of cracking or breaking. These are single-use, sterile catheters with gold marker bands used in angiographic procedures, available in 70 cm and 100 cm lengths with various tip configurations.
Potential adverse events from marker band cracking or breakage include increased procedural time, harms associated with device fragmentation or separation, and vessel injury. In a worst-case scenario, device fragmentation and separation may cause life-threatening harm or death.
Approximately 4,245 units were distributed nationwide in the US 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. Specific lot numbers for each model are identified in the recall.
Healthcare providers and patients who have received these catheters should consult with Cook Incorporated or their healthcare provider regarding the recall and appropriate next steps.
The recalled product
- Product
- Beacon Tip Centimeter Sizing Catheter RPN/GPN NR5.0-35-70-P-10S-0-CSC-20 G31213 NR5.0-35-100-P-10S-0-CSC-20 G31214 NR5.0-35-100-P-10S-PIG-CSC-20 G31216 NR5.0-35-70-P-10S-VCF-CSC-20 G31220 NR5.0-35-100-P-10S-VCF-CSC-20 G31221 Sizing catheters are single-use, sterile
- Manufacturer
- Cook Incorporated
- Hazard
- device-fracture
- marker-band-cracking
- vessel-injury
- device-fragmentation
Distribution
Distributed nationwide across the United States.