Brand Name: Ultra IABP Catheter Kit Product Name: Ultra IABP Catheter Kit Model/Catalog Number: IMU7F-40, IMU7F-35, IM
Summary
The FDA issued a Class II for Brand Name: Ultra IABP Catheter Kit Product Name: Ultra IABP Catheter Kit Mode by Insightra Medical Inc. Reason: Device contains indications for use and device compatibility claims that have not be reviewed and approved for safety and effectiveness by the FDA. In.
Details
Source
Device Recall
External ID
Z-2298-2025
Action Date
2025-08-20
Status
Terminated
Category
device
Product 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
Lot/Code Info: Lot code: All lots / UDI: IMU7F-40: 00850012832546; IMU7F-35: 00850012832515; IMU7F-30: 00850012832485; IMU7F-25: None; IMU7F-20: None
Quantity Affected: 24227 units
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.
Type: Voluntary: Firm initiated
Recall Initiated: 2025-07-19
Company
Clarksville, TN
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 169 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Insightra Medical Inc) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Insightra Medical Inc have FDA actions?
This is the only FDA action we have on record for Insightra Medical Inc in our database.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-2298-2025" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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