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Lower risk Medical device recall · FDA · Published February 7, 2019

Cordis Vista Brite Tip & Androit Guiding Catheters Recall: Frayed Packaging Pieces

Cordis recalls specific lots of Vista Brite Tip & Androit Guiding Catheters due to frayed mounting card pieces in primary packaging. No remedy is stated in the recall notice.

🇺🇸 FDA recall #Z-1198-2019Medical deviceCordis ›
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Contact the company

Recalling firmCordis Corporation14201 NW 60th Ave · Miami Lakes, FL 33014-2802
✎ GovInfoNow plain-language explainer

What happened, in plain English

Cordis is recalling specific lots of Vista Brite Tip & Androit Guiding Catheters because frayed pieces of the mounting card may be inside the primary packaging. This recall does not pose a direct safety risk to users since the catheters are medical devices used by professionals in controlled settings. Read more at govinfonow.com/recall/69038-cordis-vista-brite-tip-androit-guiding-catheters-recall-frayed-packaging.

Source Summary by GovInfoNow · govinfonow.com/recall/69038-cordis-vista-brite-tip-androit-guiding-catheters-recall-frayed-packaging · Updated August 20, 2026 · FDA enforcement record: FDA #Z-1198-2019

Cite this page

“Cordis Vista Brite Tip & Androit Guiding Catheters Recall: Frayed Packaging Pieces.” GovInfoNow, updated August 20, 2026. https://govinfonow.com/recall/69038-cordis-vista-brite-tip-androit-guiding-catheters-recall-frayed-packaging. Based on FDA recall #Z-1198-2019 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1198-2019%22&limit=1).

Why it’s dangerous

The hazard involves frayed pieces of the mounting card being inside the primary packaging. However, the recall does not indicate that these pieces pose a direct risk to users during normal medical procedures. The catheters are designed for professional use in controlled environments.

Who’s affected

Healthcare professionals who use these catheters for vascular procedures are most likely affected. The recall targets specific production lots with particular expiration dates.

How to tell if you have this one

Check the lot number and expiration date on the packaging. The affected lots are listed in the recall notice with specific expiration dates ranging from 9/30/2020 to 9/30/2021.

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

What to do — step by step

  1. Check Packaging Details

    Look for the lot number and expiration date on the packaging to determine if your catheters are affected.

Where it went and when

Where it was distributed

Distributed nationwide and abroad; the notice names 49 states.

Alaska: nationwideAKMaine: named in the noticeMEVermont: named in the noticeVTNew Hampshire: named in the noticeNHWashington: named in the noticeWAIdaho: named in the noticeIDMontana: named in the noticeMTNorth Dakota: named in the noticeNDMinnesota: named in the noticeMNIllinois: named in the noticeILWisconsin: named in the noticeWIMichigan: named in the noticeMINew York: named in the noticeNYRhode Island: named in the noticeRIMassachusetts: named in the noticeMAOregon: named in the noticeORNevada: named in the noticeNVWyoming: named in the noticeWYSouth Dakota: named in the noticeSDIowa: named in the noticeIAIndiana: named in the noticeINOhio: named in the noticeOHPennsylvania: named in the noticePANew Jersey: named in the noticeNJConnecticut: named in the noticeCTCalifornia: named in the noticeCAUtah: named in the noticeUTColorado: named in the noticeCONebraska: named in the noticeNEMissouri: named in the noticeMOKentucky: named in the noticeKYWest Virginia: named in the noticeWVVirginia: named in the noticeVAMaryland: named in the noticeMDDelaware: named in the noticeDEArizona: named in the noticeAZNew Mexico: named in the noticeNMKansas: named in the noticeKSArkansas: named in the noticeARTennessee: named in the noticeTNNorth Carolina: named in the noticeNCSouth Carolina: named in the noticeSCDistrict of Columbia: named in the noticeDCOklahoma: named in the noticeOKLouisiana: named in the noticeLAMississippi: named in the noticeMSAlabama: named in the noticeALGeorgia: named in the noticeGAHawaii: named in the noticeHITexas: named in the noticeTXFlorida: named in the noticeFLPuerto Rico: named in the noticePR

FDA distribution: “Worldwide Distribution - US Nationwide in the states of AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT,…” States read from FDA’s own wording; “not listed” means the notice does not name it.

Named in the notice: Alabama, Arizona, Arkansas, California, Colorado, Connecticut, Delaware, District of Columbia, Florida, Georgia, Hawaii, Idaho, Illinois, Indiana, Iowa, Kansas, Kentucky, Louisiana, Maine, Maryland, Massachusetts, Michigan, Minnesota, Mississippi, Missouri, Montana, Nebraska, Nevada, New Hampshire, New Jersey, New Mexico, New York, North Carolina, North Dakota, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Vermont, Virginia, Washington, West Virginia, Wisconsin, Wyoming.

Recall timeline

FDA terminated this recall 2.7 years after the firm started it.

1. Firm started the recall: Feb 7, 201912. FDA classified it Class III: Apr 18, 201923. Published in FDA’s Enforcement Report: Apr 24, 201934. FDA terminated the recall: Nov 3, 2021420192021
  1. Firm started the recall
  2. FDA classified it Class III
  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.

✎ GovInfoNow

Questions people ask

Do I need to stop using these catheters?

No, the recall does not require stopping use. The hazard is not described as causing injury during normal use.

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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-1198-2019 (February 7, 2019) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1198-2019 to see it in context.
  • Plain-language summary written by qwen3:4b on August 20, 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