Reported Apr 8, 2020 · Terminated
BD WAVELINQ 4F EndoAVF System, Arterial Catheter 50 cm, Venous Catheter 43 cm, Sterile EO, Rx only, Mfr. Bard…
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?
BD WAVELINQ 4F EndoAVF SystemArterial Catheter 50 cmVenous Catheter 43 cmSterile EORx onlyMfr. Bard Peripheral VascularIncRef W04200Lot S0053UDI (01)00801741182754(17)210215(10)S0053 -
- Product UsageThe WavelinQ 4F EndoAVF System in indicated for the creation of an arteriovenous fistula (AVF) using concomitant ulnar artery and ulnar vein or concomitant radial artery and radial vein in patients with minimum artery and vein diameters of 2.0 mm at the fistula creation site who have chronic kidney disease and need hemodialysis
- Lot codes and dates
- Product CodeW04200
- Lot/Serial NumberS0053
- Amount recalled
- 150 Units
Where it was sold
Why it was recalled
The firm has become aware of a potential problem with their venous and arterial magnetic catheters may be at risk of experiencing a magnetic deficiency, which may result in the magnets failing to attract to one another. This may result in procedural delay in obtaining or creating a functional fistula and need for additional contrast to perform the necessary fluoroscopy. This can pose an incremental risk of harm to a diabetic patient's kidney function.
This product could cause temporary or reversible health problems — stop using it.
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