Insightra Medical Inc recalls

Insightra Medical Inc recalls Brand Name: Ultra IABP Catheter Kit Product Name: Ultra IABP Catheter Kit Model/Catal…

Device contains indications for use and device compatibility claims that have not be reviewed and approved for safety and effectiveness by the FDA. Instructions for use are not consistent with product training.

• Intra-Aortic And Control Balloon System
• No Marketing Application