Cordis recalls SABER PTA Balloon Dilation Catheter (4F, REF 48004010X) due to potential contamination in the balloon sheath that could transfer foreign material to the balloon.
The balloon protective sheath may potentially be contaminated with a foreign material left over from the manufacturing process. The contaminant may transfer over from the sheath to the balloon.
Cordis is recalling a specific type of balloon dilation catheter because the protective sheath might have foreign material from manufacturing that could transfer to the balloon. This could pose a risk if the catheter is used in medical procedures.
The balloon protective sheath might contain foreign material from the manufacturing process. If this contaminant transfers to the balloon during use, it could potentially cause harm during medical procedures.
Medical professionals using the Cordis SABER PTA Balloon Dilation Catheter (4F, REF 48004010X) are likely affected. Patients undergoing procedures with this catheter may be at risk if the contaminant transfers.
Check for the product name 'Cordis SABER PTA Balloon Dilation Catheter', size 4F, and reference number 48004010X. The lot/batch number 82219442 is also associated with this recall.
Verify the product name, size, reference number, and lot/batch number to confirm if it is recalled.
The recall indicates a potential contamination risk, but the product is not unsafe unless the contaminant transfers to the balloon during use.
The recall does not specify a remedy, so check the product details to confirm if it is affected and contact Cordis for further guidance.
Look for the product name 'Cordis SABER PTA Balloon Dilation Catheter', size 4F, reference number 48004010X, and lot/batch number 82219442.
We’ve drafted a message you can send Cordis to request your refund or repair — edit it as you like.
Subject: Recall Z-2235-2021 — Cordis Cordis Hello, I own a Cordis that is covered by recall Z-2235-2021 from Cordis. 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.
