Reported Feb 5, 2020 · Terminated
Bard Conquest 40 PTA Dilation Catheter, 8mm X 20mm x 75cm (CQF7582), 8mm x 40mm x 75cm (CQF7584); Recommended Guidewire…
Bard Peripheral Vascular Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Bard Peripheral Vascular Inc · 1625 W 3rd St Bldg 1 · Tempe, AZ · 85281-2438
Is this the product you have?
6 of 6 products
| # | Barcodes | Product as published |
|---|---|---|
| 1 | Bard Conquest 40 PTA Dilation Catheter, 8mm X 20mm x 75cm (CQF7582), 8mm x 40mm x 75cm (CQF7584) | |
| 2 | Recommended Guidewire .035" | |
| 3 | Recommended Introducer 6F | |
| 4 | Nominal Pressure 8atm, Rated Burst Pressure 40atm | |
| 5 | Syringe inflation 1cc | |
| 6 | 00801741060533 | UDI: (01)00801741060533(17)220228(10)REDQ3444 |
- Lot codes and dates
- Lot Number REDQ3444 Exp02/28/2022
- Amount recalled
- 286 Units
Where it was sold
Why it was 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.
This product could cause temporary or reversible health problems — stop using it.
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