Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Bard Conquest 40 PTA Dilation Catheter Recalled by Bard Peripheral Vascular Inc Due to The catheter packaging incorrectly listed the balloon size...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Bard Peripheral Vascular Inc directly.
Affected Products
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
Quantity: 286 Units
Why Was This Recalled?
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.
Where Was This Sold?
This product was distributed to 36 states: AL, AZ, AR, CA, CO, CT, FL, GA, HI, IL, IN, IA, KS, KY, LA, MD, MA, MN, MS, MO, MT, NJ, NY, NC, ND, OH, OK, PA, SC, TN, TX, VA, WA, WV, WI, DC
About Bard Peripheral Vascular Inc
Bard Peripheral Vascular Inc has 136 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report