Recall Z-1637-2020 ยท PQK Percutaneous Catheter For Creation Of An Arteriovenous Fistula For Hemodialysis Access
Bard Peripheral Vascular Inc
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
| Date | Apr 12, 2019 |
| Status | Terminated |
| Reason | 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. |
| Root cause | Nonconforming Material/Component |
| Action | On 04/12/2019, the firm sent an "Urgent Medical Device Recall Notification" to its customers to inform them the firm has become aware that the WavelinQ 4FEndoAVF System, Product Code W04200, Lot Number S0053 may be at risk of experiencing a magnetic deficiency between the venous and arterial magnetic catheters, which may result in the magnets failing to attract to one another. The firm is instructing customers to remove any affected inventory from use and provided instructions to its customers to take regarding this product. The firm is requesting its customers to complete the required actions |
| Quantity | 150 Units |
| Distribution | 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 (E |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K182796 | WavelinQ 4F EndoAVF System C.R. Bard, Inc., Feb 6, 2019 |