Covidien Chameleon PTA Balloon Catheter Recall: Pressure Testing Failure
Covidien recalls specific lots of Chameleon PTA Balloon Catheter with Injection Port due to failure in balloon pressure testing. Affected units include 5mm to 12mm sizes with listed lot numbers and UDI-DI codes.
Recall notice
Specific lots of the Chameleon PTA Balloon Catheter failed to meet in-house balloon pressure testing.
Contact the company
What happened, in plain English
Covidien is recalling specific lots of Chameleon PTA Balloon Catheter with Injection Port that failed balloon pressure testing. This could lead to improper function during medical procedures if used without the recall fix. Read more at govinfonow.com/recall/53993-covidien-chameleon-pta-balloon-catheter-recall-pressure-testing-failure.
Source Summary by GovInfoNow · govinfonow.com/recall/53993-covidien-chameleon-pta-balloon-catheter-recall-pressure-testing-failure · Updated August 19, 2026 · FDA enforcement record: FDA #Z-0257-2025
Cite this page
“Covidien Chameleon PTA Balloon Catheter Recall: Pressure Testing Failure.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/53993-covidien-chameleon-pta-balloon-catheter-recall-pressure-testing-failure. Based on FDA recall #Z-0257-2025 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0257-2025%22&limit=1).
Why it’s dangerous
The recalled catheters failed in-house balloon pressure testing, meaning they might not maintain proper pressure during medical procedures. This could cause improper function or complications during angioplasty treatments.
Who’s affected
Medical professionals using the Chameleon PTA Balloon Catheter with Injection Port for procedures like angioplasty. Patients undergoing such procedures with the affected models are at risk if the catheter fails during use.
How to tell if you have this one
Check the product's UDI-DI code (e.g., 10884521812260) and lot numbers listed in the recall notice. The affected models include sizes from 5mm to 12mm with specific serial numbers provided in the recall details.
- Brand
Covidien- Category
Medical device
What to do — step by step
Check Product Details
Look for the UDI-DI code and lot numbers on the catheter to confirm if it's affected. The recall lists specific sizes and serial numbers for each model.
Where it went and when
Where it was distributed
Distributed nationwide, and outside the U.S.
FDA distribution: “Worldwide Distribution: US (Nationwide) and OUS (foreign) to countries of: Austria, Canada, Canary Islands, China, France, French Guiana, Germany, Greece, Guadeloupe, India, Ireland, Israel, Italy, Japan, Netherlands, Portugal, Singapore,…” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide, and outside the U.S.
Recall timeline
FDA published this recall 48 days after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
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Where this comes from
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.
- Official source: FDA Recall #Z-0257-2025 (September 19, 2024) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0257-2025 to see it in context.
- Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.