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.
Specific lots of the Chameleon PTA Balloon Catheter failed to meet in-house balloon pressure testing.
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.
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.
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.
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.
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.
The Chameleon PTA Balloon Catheter failed in-house balloon pressure testing, which could lead to improper function during medical procedures.
Affected models include 5mm to 12mm sizes with specific UDI-DI codes and lot numbers listed in the recall notice.
Check the UDI-DI code and lot numbers on the catheter. The recall lists specific serial numbers for each size, so compare your product details to the provided list.
We’ve drafted a message you can send Covidien to request your refund or repair — edit it as you like.
Subject: Recall Z-0257-2025 — Covidien Covidien Hello, I own a Covidien that is covered by recall Z-0257-2025 from Covidien. 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.
