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Ultra IABP Catheter Kit IMU7F-35Recalls & reported problems

Insightra Medical, Inc. · The Insightra Intra Aortic Balloon Catheter Kit is used in conjunction with an intra-aortic balloon pumping circuit for the emergency treatment of patients in cardiogenic shock. This condition occurs in patients post acute myocardial infarction, or with reduced cardiac output post open-heart surgery. · Class 2

Data updated Oct 18, 2026 from official FDA records · Editorial policy

Adverse event reports
0
Deaths reported
0
Injuries reported
0
Recalls naming it
1

Summary

No MAUDE adverse event reports in our data reference this device identifier directly.

1 FDA recall record name this device's identifier.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Recalls naming this device

  1. Jul 19, 2025Class IITerminated

    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.

    Z-2298-2025 · Root cause: No Marketing Application · Recall details · FDA record ↗

Other System, Balloon, Intra-Aortic And Control devices

All System, Balloon, Intra-Aortic And Control devices →

Sources and updates

How reports and recalls are matched · Editorial policy · Report an error on this page