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Unrated Medical device recall · FDA · Published January 8, 2020

Cordis POWERFLEX P3 Catheter Recall: Potential Body Shaft Voids

Cordis recalls one lot of POWERFLEX P3 PTA Dilation Catheter (REF 420-6020S) due to potential body shaft voids in the proximal seal area. Affected units have lot number 82155955 with use by date 2021-06-30.

🇺🇸 FDA recall #Z-1477-2020Medical deviceCordis ›
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Recalling firmCordis Corporation14201 NW 60th Ave · Miami Lakes, FL 33014-2802
✎ GovInfoNow plain-language explainer

What happened, in plain English

Cordis is recalling a specific lot of POWERFLEX P3 PTA Dilation Catheter because it may have body shaft voids in the proximal seal area. This could lead to improper sealing during medical procedures, potentially causing complications. Read more at govinfonow.com/recall/66144-cordis-powerflex-p3-catheter-recall-potential-body-shaft-voids.

Source Summary by GovInfoNow · govinfonow.com/recall/66144-cordis-powerflex-p3-catheter-recall-potential-body-shaft-voids · Updated August 19, 2026 · FDA enforcement record: FDA #Z-1477-2020

Cite this page

“Cordis POWERFLEX P3 Catheter Recall: Potential Body Shaft Voids.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/66144-cordis-powerflex-p3-catheter-recall-potential-body-shaft-voids. Based on FDA recall #Z-1477-2020 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1477-2020%22&limit=1).

Why it’s dangerous

The catheter may have voids in the proximal seal area, which could allow fluid or tissue to leak during medical procedures. This might cause improper sealing and potentially lead to complications like infections or ineffective treatment.

Who’s affected

Medical professionals using the Cordis POWERFLEX P3 PTA Dilation Catheter for procedures are likely affected. Patients undergoing procedures with this specific lot may be at risk.

How to tell if you have this one

Check for the lot number 82155955 on the catheter packaging. The use by date for this lot is June 30, 2021. This specific lot was sold by Cordis Corporation.

  • Brand
    Cordis
  • Category
    Medical device
Based on the official FDA remedy

What to do — step by step

  1. Check Lot Number

    Look for the lot number 82155955 on the catheter packaging or label.

How this recall unfolded

Recall timeline

FDA terminated this recall 3 years after the firm started it.

1. Firm started the recall: Jan 8, 202012. FDA classified it Class II: Mar 12, 202023. Published in FDA’s Enforcement Report: Mar 18, 202034. FDA terminated the recall: Jan 13, 2023420202023
  1. Firm started the recall
  2. FDA classified it Class II
  3. Published in FDA’s Enforcement Report
  4. FDA terminated the recall

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-1477-2020 (January 8, 2020) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1477-2020 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.
GovInfoNow is an independent guide. We are not FDA or any government agency. Always confirm details with the official recall.Data: CPSC · FDA · NHTSA · USDA