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.
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.
The catheters may have magnetic deficiencies that prevent them from attracting properly during procedures. This can lead to procedural delays and the need for additional contrast, which may increase the risk of kidney damage in diabetic patients.
Patients with chronic kidney disease who require hemodialysis and have diabetic conditions are most at risk. The affected product is used in creating arteriovenous fistulas for dialysis access.
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.
Look for the product code W04200 and lot number S0053 on the packaging or documentation.
The firm has become aware of a potential problem with the venous and arterial magnetic catheters possibly experiencing magnetic deficiency, which may cause procedural delays and increased kidney risk for diabetic patients.
Patients with chronic kidney disease who require hemodialysis and have diabetes are most at risk due to the potential for increased kidney damage.
Check for the product code W04200 and lot number S0053 on the packaging. If you have the affected product, contact Bard for further instructions.
We’ve drafted a message you can send Bard to request your refund or repair — edit it as you like.
Subject: Recall Z-1637-2020 — Bard Bard Hello, I own a Bard that is covered by recall Z-1637-2020 from Bard. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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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.
