Cook Centimeter Sizing Catheter recall due to marker band cracking
Cook Incorporated is recalling Centimeter Sizing Catheters because marker bands may crack or break, potentially causing device fragmentation, vessel injury, or life-threatening harm.
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: The recall is FDA Class I and the source text explicitly states that in a worst-case scenario, device fragmentation and separation may cause life-threatening harm or death, meeting the Critical (Class I) threshold.
Plain-English summary
Cook Incorporated is recalling the Centimeter Sizing Catheter (RPN N5.0-35-100-P-10S-PIG-CSC-20, GPN G11916) due to a safety concern with marker bands that may be at increased risk of cracking or breakage.
The marker band defect may result in device fragmentation or separation during angiographic procedures. Potential adverse events include increased procedural time, harms associated with device fragmentation and separation, and vessel injury. In a worst-case scenario, device fragmentation and separation may cause life-threatening harm or death.
Approximately 11,253 units 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. The recall affects multiple lot numbers as specified by Cook Incorporated.
Physicians and healthcare facilities using this catheter product should stop use immediately and contact Cook Incorporated for further guidance regarding return or replacement of affected units.
The recalled product
- Product
- Centimeter Sizing Catheter RPN N5.0-35-100-P-10S-PIG-CSC-20 GPN G11916 Catheters for use in angiographic procedures are available in a variety of French sizes, endhole sizes, lengths, materials and designs (e.g., polyethylene or nylon, non-braided or braided with 1:1 torque)
- Manufacturer
- Cook Incorporated
- Hazard
- device-fragmentation
- vessel-injury
- marker-band-cracking
Distribution
Distributed nationwide across the United States.