Brand Name: Ultra IABP Catheter Kit Product Name: Ultra IABP Catheter… — Class II medical device recall Z-2298-2025
Terminated recall by Insightra Medical Inc, reported 2025-08-20, distributed nationwide. Device contains indications for use and device compatibility claims that have not be reviewed and approved for
| Recall number | Z-2298-2025 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Insightra Medical Inc, Clarksville, TN, United States |
| Recall initiated | 2025-07-19 |
| Classified | 2025-08-13 |
| Reported by FDA | 2025-08-20 |
| Terminated | 2026-03-18 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, BD, BR, CO, HK, ID, IL, IN, IR, KW, LB, MY, NP, OM, PE, PK, RO, RS, RU, SA, SG |
| Quantity | 24,227 units |
| UPC / GTIN / UDI-DI | 00850012832485, 00850012832515, 00850012832546 |
| Model numbers | IMU7F-20, IMU7F-25, IMU7F-30, IMU7F-35, IMU7F-40 |
Product
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 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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2298-2025. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.