Recall Z-2298-2025 ยท DSP System, Balloon, Intra-Aortic And Control
Insightra Medical Inc
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 cardia
| Date | Aug 13, 2025 (initiated Jul 19, 2025) |
| Status | Terminated |
| Reason | 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. |
| Root cause | No Marketing Application |
| Action | On 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 |
| Quantity | 24227 units |
| 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 |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K082746 | ULTRA IABP CATHETER KIT, MODELS IMU7F-40, IMU7F-35, IMU7F-30, IMU7F-25, IMU7F-20 Insightra Medical, Inc., Jan 12, 2009 |