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U.S. Department of Health and Human Services

Class 2 Device Recall WAVELINQ 4F EndoAVF System

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  Class 2 Device Recall WAVELINQ 4F EndoAVF System see related information
Date Initiated by Firm April 12, 2019
Create Date April 02, 2020
Recall Status1 Terminated 3 on July 28, 2021
Recall Number Z-1637-2020
Recall Event ID 84946
510(K)Number K182796  
Product Classification Percutaneous catheter for creation of an arteriovenous fistula for hemodialysis access - Product Code PQK
Product 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.
Code Information Product Code: W04200  Lot/Serial Number: S0053
Recalling Firm/
Manufacturer		 Bard Peripheral Vascular Inc
1625 W 3rd St Bldg 1
Tempe AZ 85281-2438
For Additional Information Contact Garth Conrad
480-303-2602
Manufacturer 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.
FDA Determined
Cause 2		 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 and fill out the Recall and Effectiveness Check Form to confirm the quantities and lot numbers of each recalled products intended to be returned. Email the completed Recall and Effectiveness Check Form to BPV.CustomerSupportCenter@crbard.com or fax it to BPV at 1-800-994-6772. For additional questions, customers are instructed to call the BPV Customer Support Center at 1-800-321-4254 Option #5. On 04/26/2019, a second communication "Urgent Medical Device Recall Notification" letter was sent to each of the US consignees via FedEx with proof of delivery notification. The letter explained the firm's records showing the customer purchased one or more units from the affected lot. The 2nd notice was send to confirm receipt of this recall information. Firm's records indicated they have not received all returned inventory from the customer. The firm's corrective action plan is still being developed. A field action is also 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.
Quantity in Commerce 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 (EverlinQ 4F EndoAVF System). The equivalent product is not approved or sold in the US.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = PQK and Original Applicant = C. R. Bard, Inc.
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