Bard Conquest 40 PTA Dilation Catheter — Class II medical device recall Z-0917-2020
Terminated recall by Bard Peripheral Vascular Inc, reported 2020-02-05, distributed in AL, AR, AZ, CA, CO, CT, DC, FL…. The catheter packaging incorrectly listed the balloon size as 8mm X 20mm instead of the intended size 8mm X 40
| Recall number | Z-0917-2020 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Bard Peripheral Vascular Inc, Tempe, AZ, United States |
| Recall initiated | 2019-08-14 |
| Classified | 2020-01-30 |
| Reported by FDA | 2020-02-05 |
| Terminated | 2021-02-26 |
| Distributed | AL, AR, AZ, CA, CO, CT, DC, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, MN, MO, MS, MT, NC, ND, NJ, NY, OH, OK, PA, PR, SC, TN, TX, VA, WA, WI, WV |
| Quantity | 286 units |
| UPC / GTIN / UDI-DI | 00801741060533 |
| Lot numbers | REDQ3444 |
| Expiration dates | 2022-02-28 |
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0917-2020. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.