medical Class II Updated 2020-02-05

Bard Peripheral Vascular Inc recalls Bard Conquest 40 PTA Dilation Catheter, 8mm X 20mm x 75cm (C

Recalled Product

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

Hazard / Issue

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.

Issued by

FDA

Affected States: 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, WV

Lot/Code Info: Lot Number REDQ3444 Exp: 02/28/2022

View official government recall

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