CLASS II Device recall · Reported 20 Aug 2025 · FDA Enforcement Report
Ultra IABP Catheter Kit recalled by Insightra Medical
Insightra Medical is recalling Ultra IABP Catheter Kit, distributed nationwide in the US. The recall was initiated on 19 Jul 2025 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-2298-2025
- FDA event ID
- 97246
- Recalling firm
- Insightra Medical, Clarksville, TN
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 19 Jul 2025
- FDA classified
- 13 Aug 2025
- Reported
- 20 Aug 2025
- Type
- Voluntary: Firm initiated
- Customers notified by
- N/A
- Reason category
- Packaging Defects
- Device type
- Heart & Vascular Devices
Timeline
| 19 Jul 2025 | Recall initiated by company | |
| 13 Aug 2025 | Classified by FDA | +25 days |
| 20 Aug 2025 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.
Product as listed by the FDA
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
Where it was distributed
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.
Questions about this recall
Why was it recalled?
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.
Which lots are affected?
Lot code: All lots / UDI: IMU7F-40: 00850012832546; IMU7F-35: 00850012832515; IMU7F-30: 00850012832485; IMU7F-25: None; IMU7F-20: None
Where was it sold?
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.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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