# FDA recall Z-2298-2025

> **Insightra Medical Inc** · Class II · device recall initiated 2025-07-19.

## Product

Brand Name: Ultra IABP Catheter Kit  Product Name: Ultra IABP Catheter Kit  Model/Catalog Number: IMU7F-40, IMU7F-35, IMU7F-30, IMU7F-25, and IMU7F-20  Software Version: Not applicable  Product Description: The Insightra Ultra IABP Catheter Kit is a 7 French catheter available with either a 40, 35, 30, 25, or 20 cc balloon. The catheter has two lumens and is designed to provide counterpulsation cardiac assist therapy. The outer lumen is a channel for helium used to inflate and deflate the balloon. The inner lumen is used for a guidewire and blood pressure measurement. It is packaged as a convenience kit with accessories (one-way  valve, 50 cc syringe, guide wires, introducer needle, dilator, pressure tubing, Datascope & Arrow adaptors).  The balloon inflation and deflation cycle is synchronized (using a commercially available control console) with the ECG or arterial pressure to provide counterpulsation synchronized with the heartbeat. It is intended to increase coronary perfusion, dec

## Reason for recall

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.

## Distribution

Worldwide - US Nationwide distribution in the states of TX, MO, FL, MI and the countries of  Albania, Azerbaijan,	Bangladesh, Brazil, Cambodia, Colombia, Hong Kong, India, Indonesia, Iran, Israel, Saudi Arabia, Kuwait, Lebanon, Malaysia, Nepal, Oman, Pakistan, Pakistan, Peru, Romania, Russia, Serbia, Singapore, United Arab Emirates.

## Key facts

- **Recall number:** Z-2298-2025
- **Recalling firm:** Insightra Medical Inc
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2025-07-19
- **Report date:** 2025-08-20
- **Termination date:** 2026-03-18

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Clarksville, TN, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2298-2025

## Citation

> AI Analytics. FDA recall Z-2298-2025. Retrieved 2026-06-25 from https://api.ai-analytics.org/recall/Z-2298-2025. Source: US FDA. Licensed CC0.

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