MAMBA Flex 135 Microcatheter. Packaged with protective sleeve over catheter, sealed in a Tyvek pouch, and is then labeled and placed in carton with IFU. A closure strip, top and side labels are applied to the carton.
The firm initiated a removal of certain batches of MAMBA 135 and MAMBA Flex 135 Microcatheters due to incorrect labeling and packaging.
Distributed nationwide to AL, AR, AZ, CO, FL, GA, IA, IL, KY, LA, MI, MN, MO, MS, NC, ND, NV, NY, OK, OH, PR, SC, TN, VA, WA, WI and internationally to Belgium, France, Great Britain, Israel, Italy, Lithuania, Netherlands, Poland, Puerto Rico, Switzerland
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1429-2021