Z-1637-2020Class II

BD WAVELINQ 4F EndoAVF System, Arterial Catheter 50 cm, Venous Catheter 43 cm, Sterile EO, Rx only, Mfr. Bard...

Name: Z-1637-2020 BD WAVELINQ 4F EndoAVF System, Arterial Catheter 50 cm, Venous Catheter 43 cm, Sterile EO, Rx only, Mfr. Bard...
Creator: Bard Peripheral Vascular Inc
Published: 2019-04-12
License: https://open.fda.gov/license/

Bard Peripheral Vascular Inc / initiated 2019-04-12 / Terminated / root cause: manufacturing process

FDA source

Bard Peripheral Vascular Inc began a recall of 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... on 2019-04-12. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1637-2020
Classification: Class II
Status: Terminated
Initiated: 2019-04-12
Posted: 2020-04-02
Terminated: 2021-07-28
Recalling firm: Bard Peripheral Vascular Inc
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.
Product code: PQK Percutaneous Catheter For Creation Of An Arteriovenous Fistula For Hemodialysis Access
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.
Root cause tag: manufacturing process
FDA 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 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 [email protected] 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.
Product codes and lots: Product Code: W04200 Lot/Serial Number: S0053

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1637-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1637-2020	Class II	Terminated	Voluntary: Firm initiated	2020-04-08	2020-04-02

Product code PQK

K182796Class IIWavelinQ 4F EndoAVF SystemC.R. Bard, Inc. / cleared 2019-02-06

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)