Lower risk Medical device recall · FDA · Published August 14, 2019

Bard Conquest 40 Catheter Recall: Incorrect Balloon Size Risk

Bard recalls specific 40 PTA Dilation Catheters due to incorrect balloon size labeling, which may cause injury during dialysis procedures. Affected units have a risk of non-diseased vessel dilation.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #Z-0917-2020Medical device Bard ›

Lower-risk recall

The catheter packaging incorrectly listed the balloon size as 8mm X 20mm instead of the intended size 8mm X 40mm. If undetected, the user will advance the longer than expected balloon to the lesion. The potential exists that upon inflation, non-diseased vessel, kidney or sections of the AV dialysis fistulae may be dilated, potentially causing a varying degree of injury. This may require additional medical or surgical intervention.

Take action

Contact the company

Recalling firmBard Peripheral Vascular Inc1625 W 3rd St Bldg 1 · Tempe, AZ 85281-2438

✎ GovInfoNow plain-language explainer

Bard is recalling two specific models of 40 PTA Dilation Catheters because the packaging lists the wrong balloon size. This could lead to the balloon inflating in non-diseased blood vessels, kidney tissue, or dialysis fistula sections, potentially causing injury that requires medical attention. Read more at govinfonow.com/recall/67222-bard-conquest-40-catheter-recall-incorrect-balloon-size-risk.

Source Summary by GovInfoNow · govinfonow.com/recall/67222-bard-conquest-40-catheter-recall-incorrect-balloon-size-risk · Updated August 19, 2026 · FDA enforcement record: FDA #Z-0917-2020

Cite this page

“Bard Conquest 40 Catheter Recall: Incorrect Balloon Size Risk.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/67222-bard-conquest-40-catheter-recall-incorrect-balloon-size-risk. Based on FDA recall #Z-0917-2020 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0917-2020%22&limit=1).

The FDA announced on 2019-08-14 that Bard Peripheral Vascular Inc is recalling Bard Conquest 40 PTA Dilation Catheters because packaging incorrectly lists the balloon size. This error may cause unintended vessel dilation and injury if undetected during use.

How to tell if you have it

Bard Conquest 40 PTA Dilation Catheter, 8mm X 20mm x 75cm (CQF7582), 8mm x 40mm x 75cm (CQF7584); Recommended Guidewire
UPC: 00801741060533
Lot Number: REDQ3444

The hazard

The catheter packaging incorrectly listed the balloon size as 8mm X 20mm instead of the intended size 8mm X 40mm. If undetected, the user will advance the longer than expected balloon to the lesion. The potential exists that upon inflation, non-diseased vessel, kidney or sections of the AV dialysis fistulae may be dilated, potentially causing a varying degree of injury which may require additional medical or surgical intervention.

Context

GovInfoNow's records show Bard Peripheral Vascular Inc has 40 other recalls on record since 2017-09-22. Recent Bard recalls include the 2026-08-20 Bard Breast Biopsy System recall and the 2025-12-12 Bard Peripheral Vascular Recall regarding Broviac Cutdown Trays. Other recent recalls of similar products include the 2026-08-19 Olympus EZDilate Balloon Dilator Recall and the 2026-05-21 Bard PowerMidline Catheter Recall.

How to tell if you have this one

Check for the model numbers CQF7582 or CQF7584 on the catheter packaging. The catheters were sold with a specific expiration date of February 28, 2022.

Brand
Bard
Product
Bard Conquest 40 PTA Dilation Catheter, 8mm X 20mm x 75cm (CQF7582), 8mm x 40mm x 75cm (CQF7584); Recommended Guidewire
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Check Product Details
Verify the model number on the catheter packaging to confirm if it is CQF7582 or CQF7584.

Where it went and when

Where it was distributed

Distributed in 35 states and D.C. and Puerto Rico.

FDA distribution: “US: NJ, NY, OH, PA, VA, SC, GA, AR, TX, MA, NC, TN, LA, AZ, MS, FL, AL,MD, CA, HI, MO, CO, WI, DC, KY, IL, MN, IN, KS, OK, CT, MT, WA, ND, IA, WA, WV, PR OUS: None” States read from FDA’s own wording; “not listed” means the notice does not name it.

States: Alabama, Arizona, Arkansas, California, Colorado, Connecticut, District of Columbia, Florida, Georgia, Hawaii, Illinois, Indiana, Iowa, Kansas, Kentucky, Louisiana, Maryland, Massachusetts, Minnesota, Mississippi, Missouri, Montana, New Jersey, New York, North Carolina, North Dakota, Ohio, Oklahoma, Pennsylvania, Puerto Rico, South Carolina, Tennessee, Texas, Virginia, Washington, West Virginia, Wisconsin.

Recall timeline

FDA terminated this recall 18 months after the firm started it.

Aug 14, 2019Firm started the recall
Jan 30, 2020FDA classified it Class II
Feb 5, 2020Published in FDA’s Enforcement Report
Feb 26, 2021FDA terminated the recall

Dates from the agency record only; steps without a date are left out.

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Link to this recall

<a href="https://govinfonow.com/recall/67222-bard-conquest-40-catheter-recall-incorrect-balloon-size-risk">Bard Conquest 40 Catheter Recall: Incorrect Balloon Size Risk (GovInfoNow)</a>

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-0917-2020 (August 14, 2019) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0917-2020 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.