# FDA recall Z-0917-2020

> **Bard Peripheral Vascular Inc** · Class II · device recall initiated 2019-08-14.

## 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

## 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

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

## Key facts

- **Recall number:** Z-0917-2020
- **Recalling firm:** Bard Peripheral Vascular Inc
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2019-08-14
- **Report date:** 2020-02-05
- **Termination date:** 2021-02-26

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Tempe, AZ, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0917-2020

## Citation

> AI Analytics. FDA recall Z-0917-2020. Retrieved 2026-06-12 from https://api.ai-analytics.org/recall/Z-0917-2020. Source: US FDA. Licensed CC0.

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