Covidien LP 2024-11-06 Health serious FDA
Health · FDA · Recall #FDA-Z-0257-2025
Chameleon PTA Balloon Catheter with Injection Port 5mm x 40mm x 75cm (CFN CH05-40-75US),… Recall
Issued November 6, 2024 · Covidien LP
In November 2024, Covidien LP recalled the Chameleon PTA Balloon Catheter with Injection Port 5mm x 40mm x 75cm (CFN CH05-40-75US),…, a serious health recall reported by the FDA.
Compiled by Maya Ellison, RecallCheckr
What this means for you
Specific lots of the Chameleon PTA Balloon Catheter failed to meet in-house balloon pressure testing.
What you should do
- 1 Stop using Chameleon PTA Balloon Catheter with Injection Port 5mm x 40mm x 75cm (CFN CH05-40-75US),… right away.
- 2 Set it aside where it won't be used by mistake.
- 3 Contact Covidien LP 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
- Covidien LP
- Category
- Health
- Recall date
- November 6, 2024
- Units affected
- Not reported
- Sold at
- Worldwide Distribution: US (Nationwide) and OUS (foreign) to countries of: Austria, Canada, Canary Islands, China, France, French Guiana, Ge
- Recall number
- FDA-Z-0257-2025
- Made in
- United States
- Issuing agency
- FDA
In context
- Covidien LP has 6 recalls in our database, including 4 rated Critical.
- We're tracking 3,576 Health recalls in our database.
- This is the 737th Health recall we've logged in 2024.