Use cautionMedical device recall · FDA · Published April 12, 2019
Bard WavelinQ 4F EndoAVF System Recall: Magnetic Deficiency Risk for Diabetic Patients
Bard recalls WavelinQ 4F EndoAVF System due to potential magnetic deficiency in catheters, which may cause procedural delays and increased kidney risk for diabetic dialysis patients. Affected units include specific model and lot numbers.
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.
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Contact the company
📍Recalling firmBard Peripheral Vascular Inc1625 W 3rd St Bldg 1 · Tempe, AZ 85281-2438
✎ GovInfoNow plain-language explainer
Bard is recalling its WavelinQ 4F EndoAVF System catheters because they might have magnetic deficiencies that could delay procedures and increase kidney risks for diabetic patients needing dialysis. This is a serious issue for patients with chronic kidney disease who require hemodialysis. Read more at govinfonow.com/recall/68345-bard-wavelinq-4f-endoavf-system-recall-magnetic-deficiency-risk-for.
“Bard WavelinQ 4F EndoAVF System Recall: Magnetic Deficiency Risk for Diabetic Patients.” GovInfoNow, updated August 20, 2026. https://govinfonow.com/recall/68345-bard-wavelinq-4f-endoavf-system-recall-magnetic-deficiency-risk-for. Based on FDA recall #Z-1637-2020 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1637-2020%22&limit=1).
The FDA announced on April 12, 2019, that Bard Peripheral Vascular Inc voluntarily recalled the BD WAVELINQ 4F EndoAVF System due to a potential magnetic deficiency in its catheters. This defect may cause the magnets to fail to attract, resulting in procedural delays and increased risk to diabetic patients' kidney function.
How to tell if you have it
BD WAVELINQ 4F EndoAVF System
Arterial Catheter 50 cm
Venous Catheter 43 cm
Sterile EO, Rx only
Mfr. Bard
Ref W04200
Lot S0053
UPC 00801741182754
The hazard
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.
Context
GovInfoNow's records show Bard Peripheral Vascular Inc has 40 other recalls on record since September 22, 2017. Other recent recalls include the Bard Breast Biopsy System recall on August 20, 2026, and the Bard Peripheral Vascular Recall of Broviac Cutdown Trays on December 12, 2025.
How to tell if you have this one
Check for the product code W04200 and lot number S0053 on the packaging. The system is sold as a sterile, prescription-only product for creating arteriovenous fistulas in dialysis patients.
Brand
Bard
Product
BD WAVELINQ 4F EndoAVF System, Arterial Catheter 50 cm, Venous Catheter 43 cm, Sterile EO, Rx only, Mfr. Bard
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check Product Details
Look for the product code W04200 and lot number S0053 on the packaging or documentation.
Where it went and when
Where it was distributed
Distributed nationwide; the notice names 14 states.
Named in the notice
Covered by “nationwide”
Not listed
FDA 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…” States read from FDA’s own wording; “not listed” means the notice does not name it.
Named in the notice: Alabama, California, Florida, Georgia, Illinois, Indiana, Missouri, New Hampshire, New York, North Carolina, South Carolina, Tennessee, Texas, Virginia.
Recall timeline
FDA terminated this recall 2.3 years after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
4FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
Official source: FDA Recall #Z-1637-2020 (April 12, 2019) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1637-2020 to see it in context.
Plain-language summary written by qwen3:4b on August 20, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.