Insightra Medical Inc is recalling approximately 24,227 units of the Ultra IABP Catheter Kit because the device contains medical claims and instructions that have not been reviewed or approved for safety and effectiveness by the FDA. Additionally, the instructions provided with the device are inconsistent with the product training materials. The Ultra IABP Catheter is used in hospital settings to provide counterpulsation cardiac assist therapy and is sold as a kit with accessories including guide wires, needles, and pressure tubing.
The use of these devices with unapproved compatibility claims or instructions that contradict training could lead medical professionals to use the device incorrectly. This poses a risk of patient injury or ineffective heart assist therapy due to potential system incompatibilities or improper operation.
Packaged as a convenience kit with accessories including one-way valve, 50 cc syringe, guide wires, introducer needle, dilator, pressure tubing, and Datascope & Arrow adaptors.
If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.
This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.
AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.
Sources: FDA iRES · Raw API Response
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