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U.S. Department of Health and Human Services

Class 2 Device Recall Ultra IABP Catheter Kit

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 Class 2 Device Recall Ultra IABP Catheter Kitsee related information
Date Initiated by FirmJuly 19, 2025
Date PostedAugust 13, 2025
Recall Status1 Terminated 3 on March 18, 2026
Recall NumberZ-2298-2025
Recall Event ID 97246
510(K)NumberK082746 
Product Classification System, balloon, intra-aortic and control - Product Code DSP
ProductBrand 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
Code Information Lot code: All lots / UDI: IMU7F-40: 00850012832546; IMU7F-35: 00850012832515; IMU7F-30: 00850012832485; IMU7F-25: None; IMU7F-20: None
FEI Number 3003945344
Recalling Firm/
Manufacturer		 Insightra Medical Inc
2543 Madison St Ste 105
Clarksville TN 37043-2886
For Additional Information ContactSupriya Patel
931-919-2955
Manufacturer 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.
FDA Determined
Cause 2		No Marketing Application
ActionOn 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 supriya@insightra.com. 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.
Quantity in Commerce24227 units
DistributionWorldwide - 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.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database510(K)s with Product Code = DSP
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