Bard recalls Conquest PTA Balloon dilation Catheter (6mm x 40mm) due to incorrect balloon size. Using a smaller balloon may prolong procedures without serious injury risk.
Dilation catheter packaged with the wrong size balloon. The labeling states that the balloon size is 6mm x 40mm, however included is a 5mm x 40mm balloon. Use of a balloon that has a smaller diameter than expected could result in inconsequential prolongation of an existing procedure.
Take action
Contact the company
📍Recalling firmBard Peripheral Vascular Inc1625 W 3rd St Bldg 1 · Tempe, AZ 85281-2438
“Bard Conquest PTA Catheter Recall: Wrong Balloon Size May Prolong Procedure.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/64127-bard-conquest-pta-catheter-recall-wrong-balloon-size-may-prolong. Based on FDA recall #Z-0080-2021 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0080-2021%22&limit=1).
The FDA announced on Oct. 1, 2020, that Bard Peripheral Vascular Inc voluntarily recalled 281 units of Bard Conquest PTA Balloon dilation Catheters because the wrong size balloon was packaged inside. The hazard involves a labeling discrepancy where the package states a 6mm x 40mm balloon but contains a 5mm x 40mm one.
How to tell if you have it
Brand: Bard
Product: Bard Conquest PTA Balloon dilation Catheter, 6mm x 40mm, 75 cm
Cat. No.: CQ7564
UDI: (01) 00801741062902
UPC: 00801741062902
Lot No.: REDU2646
Expiration Date: 06/30/2022
The hazard
The dilation catheter was packaged with the wrong size balloon, specifically a 5mm x 40mm balloon instead of the labeled 6mm x 40mm. Use of this smaller diameter balloon could result in inconsequential prolongation of an existing procedure.
Context
GovInfoNow's records show Bard Peripheral Vascular Inc has 40 other recalls on record since 2017-09-22. Other recent recalls include the Bard Breast Biopsy System recall from 2026-08-20, the Broviac Cutdown Trays recall from 2025-12-12, and the Safe-T-Centesis Catheter Drainage Tray recall from 2025-11-06. Similar recent recalls of other products include the Bard PowerMidline Catheter recall from 2026-05-21, the Microvention Bobby Balloon Guide Catheter recall from 2026-04-30, and the Bard PowerPICC SV Catheters recall from 2026-05-21.
How to tell if you have this one
Check for the model number CQ7564 and lot number REDU2646 on the catheter packaging. The expiration date is June 30, 2022.
Brand
Bard
Product
Bard Conquest PTA Balloon dilation Catheter, 6mm x 40mm, 75 cm, Cat. No. CQ7564, UDI: (01) 00801741062902 - Product
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check Product Details
Verify the model number (CQ7564) and lot number (REDU2646) on the catheter packaging.
Where it went and when
Where it was distributed
Distributed nationwide and abroad; the notice names 14 states.
Named in the notice
Covered by “nationwide”
Not listed
FDA distribution: “Worldwide distribution - US Nationwide distribution including in the states of GA, AZ, MD, CA, VA, AR, TX, SD, NC, MO, WI, CO, FL, PA and the country of Taiwan.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Named in the notice: Arizona, Arkansas, California, Colorado, Florida, Georgia, Maryland, Missouri, North Carolina, Pennsylvania, South Dakota, Texas, Virginia, Wisconsin.
Recall timeline
FDA terminated this recall 20 months after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
4FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
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-0080-2021 (October 1, 2020) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0080-2021 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.