Bard Peripheral Vascular Inc recalls BD WAVELINQ 4F EndoAVF System, Arterial Catheter 50 cm, Venous Catheter 43 cm, Sterile EO, Rx only, Mfr. Bard Periphera…

Recall date

April 12, 2019

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1637-2020

FDA classification

Class II

Brand / firm

Bard Peripheral Vascular Inc

Sold / distributed

US Nationwide distribution in the states of NY, TN, TX, FL, NC, GA, NH, MO, CA, SC, AL, IL, VA, IN. No US Gov. Consignees No OUS Consignees for the WavelinQ 4F EndoAVF System. However, a field action is in process of being initiated for affected lot of an equivalent product sold outside the US (Eve…

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

BD WAVELINQ 4F EndoAVF System, Arterial Catheter 50 cm, Venous Catheter 43 cm, Sterile EO, Rx only, Mfr. Bard Peripheral Vascular, Inc., Ref W04200, Lot S0053, UDI (01)00801741182754(17)210215(10)S0053 - Product Usage: The 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.