FDAApril 12, 2019device

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 arterioveno...

Official recall recorded by the U.S. Food & Drug Administration.

The hazard

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.

What to do

FDA enforcement status: Terminated

Brands named

bard peripheral vascularbardbard peripheral

UPCs

00801741182754

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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