FDA Device recall Z-1637-2020
BD WAVELINQ 4F EndoAVF System, Arterial Catheter 50 cm, Venous Catheter 43 cm, Sterile EO, Rx only, Mfr
- FDA Device
- Class II
- terminated
- Published 2020-04-08
On 2020-04-08 the FDA classified a Class II recall of BD WAVELINQ 4F EndoAVF System, Arterial Catheter 50 cm, Venous Catheter 43 cm, Sterile EO, Rx only, Mfr by Bard Peripheral Vascular, citing 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 ma….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1637-2020 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2019-04-12 |
| Published | 2020-04-08 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Bard Peripheral Vascular |
| Distribution | US |
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.
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.
Identifiers
| code_info | Product Code: W04200 Lot/Serial Number: S0053 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.
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Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1637-2020%22
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