Covidien recalls EsoFLIP 30mm balloon dilation catheters (REF ES-330) due to potential inaccurate esophageal diameter measurements that could lead to harmful outcomes. Affected units include specific lots from 2022-2024.
Due to saline conductivity issues, their is a potential that dilation catheters may provide inaccurate esophageal diameter measurements that may lead to various harms.
Covidien is recalling EsoFLIP 30mm balloon dilation catheters (REF ES-330) because saline conductivity issues might cause inaccurate esophageal diameter measurements during procedures. This could lead to complications like improper treatment or injury if the catheter is used incorrectly.
The catheter's saline conductivity issues can cause it to provide inaccurate esophageal diameter measurements. This might lead to improper treatment decisions, such as using the wrong size catheter, which could cause injury or complications during procedures.
Healthcare professionals using these catheters for endoscopic procedures are most at risk. Patients receiving the catheter for dilation may also be affected if the measurement error impacts treatment.
Check for the product name 'EsoFLIP 30mm Balloon Dilation Catheter' with reference number ES-330. Affected units include specific lots listed in the recall notice, such as 22K0854JZ through 24B0392JZ.
Look for the product name 'EsoFLIP 30mm Balloon Dilation Catheter' with reference number ES-330 on the packaging or label.
The recall states that saline conductivity issues may lead to inaccurate measurements, but it does not specify that the product is unsafe to use. Users should check if their unit is affected and follow the recall instructions.
The recall does not provide a remedy, so there is no action required. However, you should check if your unit is affected by reviewing the specific lots listed in the recall notice.
Check the product name and reference number on the packaging. Affected units include specific lots from 2022 through 2024 as listed in the recall notice.
We’ve drafted a message you can send Covidien to request your refund or repair — edit it as you like.
Subject: Recall Z-2038-2024 — Covidien Covidien Hello, I own a Covidien that is covered by recall Z-2038-2024 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.
