Bard Conquest 40 PTA Dilation Catheter, 8mm X 20mm x 75cm (CQF7582), 8mm x 40mm x 75cm (CQF7584);...

FDA Device Recall #Z-0917-2020 — Class II — August 14, 2019

Recall Summary

Recall Number Z-0917-2020
Classification Class II — Moderate risk
Date Initiated August 14, 2019
Status Terminated
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm Bard Peripheral Vascular Inc
Location Tempe, AZ
Product Type Devices
Quantity 286 Units

Product Description

Bard Conquest 40 PTA Dilation Catheter, 8mm X 20mm x 75cm (CQF7582), 8mm x 40mm x 75cm (CQF7584); Recommended Guidewire .035"; Recommended Introducer 6F; Nominal Pressure 8atm, Rated Burst Pressure 40atm; Syringe inflation 1cc; UDI: (01)00801741060533(17)220228(10)REDQ3444

Reason for 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.

Distribution Pattern

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

Lot / Code Information

Lot Number REDQ3444 Exp: 02/28/2022

Other Recalls from Bard Peripheral Vascular Inc

Recall # Classification Product Date
Z-1367-2026 Class II Broviac 4.2 Fr Single-Lumen CV Catheter Cutdown... Dec 12, 2025
Z-0887-2026 Class II Safe-T-Centesis 6 Fr Catheter Drainage Tray, RE... Nov 6, 2025
Z-2638-2025 Class II Venclose digiRF Generators, Model VCRFG1, with ... Aug 21, 2025
Z-1244-2025 Class I Rotarex Atherectomy System and Instructions for... Feb 5, 2025
Z-0467-2025 Class II Bard Marquee Disposable Core Biopsy Instrument ... Sep 30, 2024

Frequently Asked Questions

Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.

Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.

Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.

What Should You Do?

Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.