BEUDAMED
    FDA Recall Terminated

    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, decrease the workload of the left ventricle and allow healing of the myocardium Component: No

    Recall: Z-2298-2025 · Initiated July 19, 2025

    Recall

    Recall Number
    Z-2298-2025
    Event Number
    97246
    Firm
    Insightra Medical Inc
    FEI Number
    3003945344
    Product Code
    DSP
    Status
    Terminated
    Root Cause
    No Marketing Application
    Initiated
    July 19, 2025
    Posted
    August 13, 2025
    Terminated
    March 18, 2026
    Address
    2543 Madison St, Ste 105, Clarksville, TN, 37043-2886

    Description

    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, decrease the workload of the left ventricle and allow healing of the myocardium Component: No

    Reason

    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.

    Action

    On June 19, 2025, Insightra Medical issued a recall notification to affected consignees via postal mail and email. On August 4, 2025, Insightra Medical issued a "Urgent Medical Device Recall" notification update via E-Mail to provide additional information concerning the labeling. Insightra ask consignees to take the following actions: 1. Inform consignees to discard any previously printed versions of the IFU. 2.Review your firm s procedures and processes to ensure that they are up to date with the updated IFU. 3.If your firm has further distributed the devices to other facilities, please provide that facility with a copy of the notification. 4.Ensure that all clinicians and users are informed of the IFU updates. 5.Access the latest IFU via the QR code located inside the product box lid or via web address: https://tn-mi.com/wp-content/uploads/2023/06/D02-0043-Ultra-IAB-IFU-2019.pdf 6.Retain the letter with your product documentation. 7.Please email the acknowledgement form to us at [email protected]. 8. Report any device concerns to Insightra. Please note that adverse reactions or quality problems experienced with the use of this product may be reported to the FDA s MedWatch Adverse Event Reporting program either online, by regular mail or by fax.

    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.

    Quantity

    24227 units