Bard WavelinQ 4F EndoAVF System Recalled for Magnetic Deficiency
Bard Peripheral Vascular is recalling 150 units of the WavelinQ 4F EndoAVF System because magnetic catheters may fail to attract, potentially delaying fistula creation.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a risk-of-harm product where injury has not yet been reported, specifically an incremental risk to kidney function in diabetic patients due to potential procedural delays and additional contrast use.
Plain-English summary
Bard Peripheral Vascular, Inc. is recalling 150 units of the BD WAVELINQ 4F EndoAVF System, Reference W04200, Lot S0053. The product is indicated for the creation of an arteriovenous fistula in patients with chronic kidney disease who need hemodialysis. The recall is limited to the United States, with distribution in 14 states including New York, Texas, and California.
The firm identified a potential problem where the venous and arterial magnetic catheters may experience a magnetic deficiency. This defect may result in the magnets failing to attract to one another. Such a failure could cause procedural delays in obtaining or creating a functional fistula and may require the use of additional contrast for fluoroscopy. This can pose an incremental risk of harm to a diabetic patient's kidney function.
No specific instructions for consumers are provided in the source text, as this is a prescription-only medical device used in clinical settings. Healthcare providers should verify the lot number of their inventory against the recall details.
The recalled product
- 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…
- Manufacturer
- Bard Peripheral Vascular Inc
- Category
- Medical Device — Catheter
- Affected units
- 150
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Product Code: W04200 Lot/Serial Number: S0053
Distribution
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