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Unrated Medical device recall · FDA · Published September 22, 2017

Angiodynamics Soft-Vu Omni Flush Catheter Recall: Post-Sterilization Release Issue

Angiodynamics recalls Soft-Vu Omni Flush Angiographic Catheters due to incomplete post-sterilization release activities. Affected units may have safety risks during medical procedures.

🇺🇸 FDA recall #Z-0742-2018Medical deviceAngiodynamics ›
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Recalling firmAngiodynamics, Inc.603 Queensbury Ave · Queensbury, NY 12804-7619
✎ GovInfoNow plain-language explainer

What happened, in plain English

Angiodynamics is recalling a specific type of angiographic catheter because it was distributed before all required post-sterilization steps were completed. This could pose safety risks during medical procedures. Read more at govinfonow.com/recall/72954-angiodynamics-soft-vu-omni-flush-catheter-recall-post-sterilization-release.

Source Summary by GovInfoNow · govinfonow.com/recall/72954-angiodynamics-soft-vu-omni-flush-catheter-recall-post-sterilization-release · Updated September 17, 2026 · FDA enforcement record: FDA #Z-0742-2018

Cite this page

“Angiodynamics Soft-Vu Omni Flush Catheter Recall: Post-Sterilization Release Issue.” GovInfoNow, updated September 17, 2026. https://govinfonow.com/recall/72954-angiodynamics-soft-vu-omni-flush-catheter-recall-post-sterilization-release. Based on FDA recall #Z-0742-2018 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0742-2018%22&limit=1).

Why it’s dangerous

The catheter was distributed before all necessary post-sterilization release activities were completed. This could mean the device is not fully safe for medical use, potentially leading to complications during procedures.

Who’s affected

Medical professionals using this catheter for angiographic procedures are likely affected. Patients undergoing such procedures with the recalled model face the highest risk.

How to tell if you have this one

Check for the model number SV OF 5F x 65 cm .035 NB PG and catalog number 10732201. The catheter was manufactured on September 6, 2017, and expires August 31, 2020.

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

What to do — step by step

  1. Check Product Details

    Verify the model number SV OF 5F x 65 cm .035 NB PG and catalog number 10732201 to confirm if your catheter is affected.

Where it went and when

Where it was distributed

Distributed in 14 states.

Alaska: not listedAKMaine: not listedMEVermont: not listedVTNew Hampshire: not listedNHWashington: not listedWAIdaho: not listedIDMontana: not listedMTNorth Dakota: not listedNDMinnesota: yesMNIllinois: yesILWisconsin: not listedWIMichigan: yesMINew York: not listedNYRhode Island: not listedRIMassachusetts: not listedMAOregon: yesORNevada: not listedNVWyoming: not listedWYSouth Dakota: not listedSDIowa: not listedIAIndiana: yesINOhio: yesOHPennsylvania: not listedPANew Jersey: not listedNJConnecticut: yesCTCalifornia: yesCAUtah: not listedUTColorado: not listedCONebraska: not listedNEMissouri: yesMOKentucky: not listedKYWest Virginia: not listedWVVirginia: not listedVAMaryland: yesMDDelaware: not listedDEArizona: not listedAZNew Mexico: not listedNMKansas: not listedKSArkansas: not listedARTennessee: not listedTNNorth Carolina: not listedNCSouth Carolina: not listedSCDistrict of Columbia: not listedDCOklahoma: not listedOKLouisiana: not listedLAMississippi: not listedMSAlabama: yesALGeorgia: yesGAHawaii: not listedHITexas: yesTXFlorida: yesFL

FDA distribution: “US Distribution to the states of : AL, CA, CT, FL, GA, IL, IN, MD, MI, MN, MO, OH, OR, TX.” States read from FDA’s own wording; “not listed” means the notice does not name it.

States: Alabama, California, Connecticut, Florida, Georgia, Illinois, Indiana, Maryland, Michigan, Minnesota, Missouri, Ohio, Oregon, Texas.

Recall timeline

FDA terminated this recall 12 months after the firm started it.

1. Firm started the recall: Sep 22, 201712. FDA classified it Class II: Feb 27, 201823. Published in FDA’s Enforcement Report: Mar 7, 201834. FDA terminated the recall: Sep 19, 2018420172018
  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-0742-2018 (September 22, 2017) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0742-2018 to see it in context.
  • Plain-language summary written by qwen3:4b on September 17, 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