Bard Peripheral Vascular Inc: Medical Device Recall in 2020 - (Recall #: Z-0917-2020)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2020.

Data Source: FDA.

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

Product Classification:

Class II

Date Initiated: August 14, 2019

Date Posted: February 5, 2020

Recall Number: Z-0917-2020

Event ID: 84659

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.

Status: Terminated

Product Quantity: 286 Units

Code Information:

Lot Number REDQ3444 Exp: 02/28/2022

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

Voluntary or Mandated:

Voluntary: Firm initiated