Brand Name: Ultra IABP Catheter Kit Product Name: Ultra IABP Catheter Kit Model/Catalog Number: IMU7F-40, IMU7F-35, IMU7
FDA device recall Z-2298-2025 · posted 2025-08-13 · Terminated
Recall details
- Recalling firm
- Insightra Medical Inc
- 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.
- Action taken
- 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 provide that facility with a copy of the notification. 4.Ensure that all clinicians and users are informed of the IFU updates. 5.Access the latest IFU via the QR code located inside the product box lid or via web address: https://tn-mi.com/wp-content/uploads/2023/06/D02-0043-Ultra-IAB-IFU-2019.pdf 6.Retain the letter with your product documentation. 7.Please email the acknowledgement form to us at supriya@insightra.com. 8. Report any device concerns to Insightra. Please note that adverse reactions or quality problems experienced with the use of this product may be reported to the FDA s MedWatch Adverse Event Reporting program either online, by regular mail or by fax.
- Root cause
- No Marketing Application
- Status
- Terminated
- Product code
- DSP
- Quantity affected
- 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, Saud
- Date initiated
- 2025-07-19
- Date posted
- 2025-08-13
- Date terminated
- 2026-03-18
- Location
- Clarksville, TN
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| ULTRA IABP CATHETER KIT, MODELS IMU7F-40, IMU7F-35, IMU7F-30, IMU7F-25, IMU7F-20 (K082746) | Insightra Medical, Inc. | 2009-01-12 |