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 SABER PTA Catheter Recall: Contaminated Balloon Sheath Risk.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/62195-cordis-saber-pta-catheter-recall-contaminated-balloon-sheath-risk. Based on FDA recall #Z-2235-2021 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2235-2021%22&limit=1).
The FDA announced on July 19, 2021, that Cordis Corporation is recalling the Cordis SABER PTA Balloon Dilation Catheter, 4F, REF 48004010X due to potential contamination with foreign material. The agency said the contaminant may transfer from the balloon protective sheath 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.
Context
GovInfoNow's records show Cordis Corporation has issued 9 other recalls since November 15, 2017. Recent Cordis recalls include a SMART Flex Biliary Stent on October 1, 2021, for potential dislodgement, and a SUPER TORQUE MB 5F PIG Catheter on July 21, 2021, for entrapment risk. Other recent recalls of similar products include the Microvention Bobby Balloon Guide Catheter (April 30, 2026) and Medline Medical Procedure Kits (May 4, 2026).
How to tell if you have this one
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.
Brand
Cordis
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check Product Details
Verify the product name, size, reference number, and lot/batch number to confirm if it is recalled.
Where it went and when
Where it was distributed
Distributed nationwide and abroad; the notice names 2 states.
Named in the notice
Covered by “nationwide”
Not listed
FDA distribution: “Worldwide distribution - US Nationwide distribution in the states of CA, OH, and the countries of Switzerland, Portugal, and Poland.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Named in the notice: California, Ohio.
Recall timeline
FDA terminated this recall 19 months after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
4FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
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-2235-2021 (July 19, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2235-2021 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.