Z-1637-2020 Class II Terminated
Recalled by Bard Peripheral Vascular Inc
— Tempe, AZ
FDA device recall Z-1637-2020 was initiated by Bard Peripheral Vascular Inc on April 12, 2019 and is designated Class II. Reason for recall: 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 attr… The recall status is terminated (terminated July 28, 2021). Affected quantity: 150 Units.
Recall Details
- Product Type
- Devices
- Report Date
- April 8, 2020
- Initiation Date
- April 12, 2019
- Termination Date
- July 28, 2021
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 150 Units
Product Description
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.
Reason for Recall
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.
Distribution Pattern
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 (EverlinQ 4F EndoAVF System). The equivalent product is not approved or sold in the US.
Code Information
Product Code: W04200 Lot/Serial Number: S0053