Insightra Medical recalls Ultra IABP Catheter Kits (models IMU7F-20 to IMU7F-40) due to unapproved FDA safety claims and inconsistent instructions. Consumers should contact the manufacturer for details.
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.
Insightra is recalling its Ultra IABP Catheter Kits (models IMU7F-20 to IMU7F-40) because the device's safety and effectiveness claims weren't reviewed by the FDA, and the instructions don't match product training. This could lead to improper use if the device isn't used correctly.
The device has unapproved FDA safety and effectiveness claims, meaning it wasn't tested for safety as required. Additionally, the instructions for use don't align with how the product is trained, which could lead to improper use if the device isn't handled correctly.
Healthcare professionals using the Ultra IABP Catheter Kit for cardiac assist therapy are most at risk. Patients receiving this device may also be affected if the kit is used incorrectly.
Check for model numbers IMU7F-20, IMU7F-25, IMU7F-30, IMU7F-35, or IMU7F-40 on the kit packaging. The product is sold for cardiac assist therapy in medical settings.
Reach out to Insightra Medical Inc for specific guidance on the recall and next steps.
The device contains safety and effectiveness claims not approved by the FDA, and the instructions for use don't match product training.
Models IMU7F-20, IMU7F-25, IMU7F-30, IMU7F-35, and IMU7F-40.
The recall does not require immediate discontinuation; contact the manufacturer for specific guidance.
We’ve drafted a message you can send Insightra to request your refund or repair — edit it as you like.
Subject: Recall Z-2298-2025 — Insightra Insightra Hello, I own a Insightra that is covered by recall Z-2298-2025 from Insightra. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
