Insightra Medical Inc 2025-08-20 Health serious FDA
Health · FDA · Recall #FDA-Z-2298-2025
Brand Name: Ultra IABP Catheter Kit Product Name: Ultra IABP Catheter Kit Model/Catalog… Recall
Issued August 20, 2025 · Insightra Medical Inc
In August 2025, Insightra Medical Inc recalled the Brand Name: Ultra IABP Catheter Kit Product Name: Ultra IABP Catheter Kit Model/Catalog…, a serious health recall reported by the FDA.
Compiled by Maya Ellison, RecallCheckr
What this means for you
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.
What you should do
- 1 Stop using Brand Name: Ultra IABP Catheter Kit Product Name: Ultra IABP Catheter Kit Model/Catalog… right away.
- 2 Set it aside where it won't be used by mistake.
- 3 Contact Insightra Medical Inc to arrange your voluntary. See the official notice below for contact details.
- 4 Keep the product until your remedy is fully processed. You may need it.
Official remedy (Voluntary):
Recall details
- Brand
- Insightra Medical Inc
- Category
- Health
- Recall date
- August 20, 2025
- Units affected
- Not reported
- Sold at
- Worldwide - US Nationwide distribution in the states of TX, MO, FL, MI and the countries of Albania, Azerbaijan, Bangladesh, Brazil, Cambod
- Recall number
- FDA-Z-2298-2025
- Made in
- United States
- Issuing agency
- FDA
In context
- Insightra Medical Inc has 1 recall in our database.
- We're tracking 3,576 Health recalls in our database.
- This is the 691st Health recall we've logged in 2025.