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Insightra Medical Recalls

1 recall on record · August 20, 2025 to August 20, 2025 · Medical Devices

August 20, 2025Medical DevicesFDA

Insightra Medical Inc recalls Brand Name: Ultra IABP Catheter Kit Product Name: Ultra IABP Catheter Kit Model/Catalog Number: IMU7F-40, IMU7F-35, IM

Hazard: 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.

Insightra Medical Recalls | RecallWatchUSA