Reported Aug 20, 2025 · Terminated
Brand Name: Ultra IABP Catheter Kit Product Name: Ultra IABP Catheter Kit Model/Catalog Number: IMU7F-40, IMU7F-35,…
Insightra Medical Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Insightra Medical Inc · 2543 Madison St Ste 105 · Clarksville, TN · 37043-2886
Is this the product you have?
- Brand NameUltra
- IABP Catheter Kit Product NameUltra
- IABP Catheter Kit Model/Catalog Number
IMU7F-40IMU7F-35IMU7F-30IMU7F-25
- and IMU7F-20 Software VersionNot
- applicable Product DescriptionThe 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 ComponentNo
- Lot codes and dates
- Lot codeAll
- lots / UDIIMU7F-40: 00850012832546
- IMU7F-3500850012832515
- IMU7F-3000850012832485
- IMU7F-25None
- IMU7F-20None
- Amount recalled
- 24227 units
Where it was sold
Why it was 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.
This product could cause temporary or reversible health problems — stop using it.
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