Cordis PRECISE PRO RX Carotid Stent Recall: Distal Tip Separation Risk
Cordis recalls specific lots of PRECISE PRO RX carotid stent implants due to risk of distal tip separation from lumen wire. Affected product codes and lot numbers listed.
Lower-risk recall
Distal tip may become separated from the lumen wire in specific lots.
Contact the company
What happened, in plain English
Cordis is recalling certain lots of PRECISE PRO RX carotid stent implants because the distal tip may separate from the lumen wire in specific batches. This could lead to improper placement or complications during medical procedures. Read more at govinfonow.com/recall/63282-cordis-precise-pro-rx-carotid-stent-recall-distal-tip-separation.
Source Summary by GovInfoNow · govinfonow.com/recall/63282-cordis-precise-pro-rx-carotid-stent-recall-distal-tip-separation · Updated August 19, 2026 · FDA enforcement record: FDA #Z-1257-2021
Cite this page
“Cordis PRECISE PRO RX Carotid Stent Recall: Distal Tip Separation Risk.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/63282-cordis-precise-pro-rx-carotid-stent-recall-distal-tip-separation. Based on FDA recall #Z-1257-2021 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1257-2021%22&limit=1).
Why it’s dangerous
The distal tip of the stent may become separated from the lumen wire in specific batches, potentially causing improper placement during medical procedures. This could lead to complications if the stent does not function correctly.
Who’s affected
Patients who received the recalled carotid stent implants during surgery are likely affected. Medical professionals using these implants for procedures are at risk if they handle the affected lots.
How to tell if you have this one
Check the product code (PC0520RXC through PC1040RXC) and lot number listed in the recall notice. The affected lots are detailed in the product codes and specific lot numbers provided.
- Brand
Cordis- Category
Medical device
What to do — step by step
Check Product Details
Review the product code and lot number on your implant to see if it matches the recalled items listed in the notice.
How this recall unfolded
Recall timeline
FDA published this recall 41 days after the firm started it.
- Firm started the recall
- FDA classified it Class I
- Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
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Where this comes from
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-1257-2021 (February 11, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1257-2021 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.