Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Cordis SABER PTA Balloon Dilation Catheter Recalled by Cordis Corporation Due to Foreign Object Contamination
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Cordis Corporation directly.
Affected Products
Cordis SABER PTA Balloon Dilation Catheter, 4F, REF 48004010X
Quantity: 8 units
Why Was This Recalled?
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.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Cordis Corporation
Cordis Corporation has 39 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report