# FDA recall Z-1637-2020

> **Bard Peripheral Vascular Inc** · Class II · device recall initiated 2019-04-12.

## 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 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

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.

## Key facts

- **Recall number:** Z-1637-2020
- **Recalling firm:** Bard Peripheral Vascular Inc
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2019-04-12
- **Report date:** 2020-04-08
- **Termination date:** 2021-07-28

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Tempe, AZ, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1637-2020

## Citation

> AI Analytics. FDA recall Z-1637-2020. Retrieved 2026-07-03 from https://api.ai-analytics.org/recall/Z-1637-2020. Source: US FDA. Licensed CC0.

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